Publications by authors named "Linong Ji"

320 Publications

Effect of Baseline Characteristics on Hypoglycaemia Risk with Insulin Glargine 100 U/mL: Post Hoc Analysis of the BEYOND 7 Study.

Diabetes Ther 2021 Jul 21. Epub 2021 Jul 21.

Peking University People's Hospital, Beijing, China.

Introduction: BEYOND 7 demonstrated that a higher starting dose (0.3 U/kg) of insulin glargine 100 U/mL (Gla-100) is as safe as the standard starting dose (0.2 U/kg) in Chinese individuals with type 2 diabetes who had uncontrolled hyperglycaemia despite receiving oral antihyperglycaemic drugs. This post hoc analysis determined the effect of baseline characteristics on hypoglycaemia risk in these individuals.

Methods: Participants from BEYOND 7 were assessed based on their age at baseline (< 60 vs. ≥ 60 years), duration of diabetes (< 10 vs. ≥ 10 years), glycated haemoglobin (HbA1c; < 9 vs. ≥ 9%) and fasting plasma glucose level (FPG; < 11 vs. ≥ 11 mmol/L). Endpoints included the proportion of participants with overall confirmed (≤ 3.9 mmol/L) and symptomatic hypoglycaemia, as well as the proportion of participants who achieved an HbA1c < 7% without hypoglycaemia, the time to first achievement of fasting blood glucose (FBG) < 7 mmol/L and the change in HbA1c from baseline between the two treatment arms in each of these subgroups.

Results: The proportion of participants with overall confirmed (6.1-16.7%) or symptomatic hypoglycaemia (5.7-18.4%) or the proportion who achieved HbA1c < 7.0% without hypoglycaemia (23.6-47.4%) was similar between the two treatment arms in all subgroups, with the exception of participants with a baseline duration of diabetes ≥ 10 years who experienced more symptomatic hypoglycaemia if initiating Gla-100 at a dose of 0.3 versus 0.2 U/kg. Participants aged < 60 years with an HbA1c < 9% or ≥ 9% or a duration of diabetes of 2-10 years achieved an FBG < 7.0 mmol/L in a significantly shorter time with Gla-100 starting dose of 0.3 U/kg versus 0.2 U/kg (all p < 0.001). No significant differences were seen among the subgroups in terms of change from baseline in HbA1c.

Conclusions: Baseline age, duration of diabetes, HbA1c level and FPG level do not affect the risk of hypoglycaemia with a higher starting dose of Gla-100 versus its standard starting dose.

Trial Registration: ClinicalTrials.gov: NCT02836704.
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http://dx.doi.org/10.1007/s13300-021-01112-zDOI Listing
July 2021

NAFLD or MAFLD: Which Has Closer Association With All-Cause and Cause-Specific Mortality?-Results From NHANES III.

Front Med (Lausanne) 2021 1;8:693507. Epub 2021 Jul 1.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

The recent change of terminology from non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated fatty liver disease (MAFLD) has raised heated discussion. We aim to investigate the association of MAFLD or NAFLD with all-cause and cause-specific mortality to compare the outcomes of the two diagnostic criteria in population-based study. We recruited 12,480 participants from the Third National Health and Nutrition Examination Survey (NHANES III) with matched mortality data in 2015. Participants were divided into four groups for survival analysis: without NAFLD or MAFLD, with only NAFLD, only MAFLD. Cox proportional hazard regression was used to estimate multivariable-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for all-cause and cause-specific mortality. Subgroup analysis were applied in MAFLD patients. The weighted prevalence of MAFLD and NAFLD was relatively 27.4 and 27.9%. Participants with NAFLD or MAFLD were largely overlapped (weighted Cohen's kappa coefficient 0.76). MAFLD increased the overall risk for total mortality in a greater magnitude than NAFLD [HR 2.07 (95% CI 1.86, 2.29) vs. 1.47 (1.20, 1.79)], However, the difference was non-significant after metabolic parameters were adjusted. Risks for cardiovascular, neoplasm, and diabetes-related mortality were similar between MAFLD and NAFLD. Referring to individuals without both NAFLD and MAFLD, individuals with only NAFLD showed reduced total mortality [HR 0.48 (0.34, 0.68)] and neoplasm mortality [HR 0.46 (0.24, 0.89)] in crude. Nevertheless, individuals with only MAFLD independently increased the risk for total mortality [adjusted HR 1.47 (1.22, 1.77)] and neoplasm mortality [aHR 1.58 (1.09, 2.28)]. The risk for overall mortality in MAFLD was consistent between subgroups except for race-ethnicity and whether secondary to viral hepatitis. Participants with MAFLD or NAFLD were highly concordant. MAFLD showed greater risk for all-cause mortality and equal risk for cause-specific mortality referring to NAFLD. The new terminology excluded participants with lower mortality risk and included participants with higher risk. Drug development for MAFLD should consider ethnic differences.
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http://dx.doi.org/10.3389/fmed.2021.693507DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8280321PMC
July 2021

Cardiovascular outcomes of antidiabetes medications by race/ethnicity: A systematic review and meta-analysis.

J Diabetes Complications 2021 Jun 27:107980. Epub 2021 Jun 27.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing 100044, China. Electronic address:

Background: The consistency of cardiovascular risk reduction by antidiabetes medications across racial and ethnic groups remains unclear. The aim of this study was to analyze racial/ethnic patterns in the results of cardiovascular outcomes trials of antidiabetes medications in people with type 2 diabetes.

Method: PubMed and Cochrane library databases were searched from the inception dates to December 2020. Cardiovascular outcome trials in type 2 diabetes that randomized participants to antidiabetes medication or control treatment and reported results by race/ethnic groups or region were included.

Results: A total of 19 studies were included in this meta-analysis. Among White participants, treatment with antidiabetes medications significantly decreased the risk of composite cardiovascular outcomes when compared with placebo treatment (OR = 0.88, 95% CI 0.83-0.94, p < 0.05). Among Asian participants, antidiabetes medications also significantly decreased the risk of composite cardiovascular outcomes when compared with control treatment (OR = 0.80, 95% CI 0.74-0.86, p < 0.05). A similar pattern was found when analyzing the effects of antidiabetes medications vs. control treatment in other racial/ethnic groups comprising mostly Hispanics and Pacific Islanders (OR = 0.87, 95% CI 0.78-0.98, p < 0.05). However, among Black participants, treatment with antidiabetes medications resulted in nominal but non-significant decreases in the composite cardiovascular outcomes when compared with control treatment (OR = 0.84, 95% CI 0.62-1.14, p = 0.26).

Conclusions: The present meta-analysis showed cardiovascular safety of antidiabetes medications in people with type 2 diabetes from all racial/ethnic groups studied; however, significant composite cardiovascular risk reductions were demonstrated only in White and Asian participants. To determine whether antidiabetes drugs confer consistent cardiovascular benefits in Black and other racial/ethnic participants requires more investigations in the future.
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http://dx.doi.org/10.1016/j.jdiacomp.2021.107980DOI Listing
June 2021

Early versus late intensification of glucose-lowering therapy in patients with type 2 diabetes: Results from the DISCOVER study.

Diabetes Res Clin Pract 2021 Jul 10;178:108947. Epub 2021 Jul 10.

Juntendo University, Tokyo, Japan.

Aims: To assess the effects of glycated haemoglobin (HbA) levels at time of glucose-lowering treatment intensification in DISCOVER, a global observational study of patients with type 2 diabetes (T2D) initiating second-line therapy. Outcomes of interest were glycaemic control, hypoglycaemia, and need for further intensification during 3 years of follow-up.

Methods: We included patients who intensified treatment (add-on or insulin initiation) upon initiation of second-line therapy (baseline). Outcomes were assessed according to baseline HbA: HbA ≤ 7·5% (early intensification) or HbA > 7·5% (late intensification). Factors associated with early or late intensification were assessed using multivariate logistic regression.

Results: Of the 9575 patients included, 3275 (34·2%) intensified treatment early and 6300 (65·8%) intensified treatment late. During follow-up, mean (SD) HbA was lower in the early- than in the late-intensification group (6·9% [0·95%] vs 7·5% [1·28%] at 36 months). More patients had HbA < 7·0% in the early- than in the late-intensification group (61·8% vs 37·9% at 36 months; p < 0·001). The risk of further intensification was higher in the late-intensification group (hazard ratio 1·88 [95% confidence interval 1·68-2·09]). Occurrence of hypoglycaemia was similar in both groups.

Conclusions: Late intensification of glucose-lowering therapy after first-line treatment failure reduces the likelihood of reaching recommended treatment goals.
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http://dx.doi.org/10.1016/j.diabres.2021.108947DOI Listing
July 2021

What are the factors associated with long-term glycaemic control in patients with type 2 diabetes and elevated HbA1c (≥7.0%) at initiation of second-line therapy? Results from the DISCOVER study.

Diabetes Obes Metab 2021 Jul 1. Epub 2021 Jul 1.

University of Leicester, Leicester, UK.

Aims: Glycaemic control is a cornerstone of type 2 diabetes (T2D) management. We assessed factors associated with good long-term glycaemic control in patients with glycated haemoglobin (HbA1c) ≥7.0% at initiation of second-line glucose-lowering therapy, using data from DISCOVER, a global, prospective, 3-year observational study of patients with T2D.

Materials And Methods: This analysis included patients with HbA1c ≥7.0% at baseline (initiation of second-line therapy). Multivariable regression models assessed factors associated with having HbA1c <7.0% at 3 years in 3 years in two distinct groups: patients with (1) HbA ≥7.0% and <9.0% and (2) HbA ≥9.0% at baseline.

Results: In total, 7575 patients with baseline HbA1c ≥7.0% were included (2233 with baseline HbA1c ≥9.0%). At 6 months, 43.7% and 24.2% of patients had an HbA level < 7.0% in group 1 and 2, respectively; the corresponding proportions at 3 years were 45.8% and 29.3%. Having HbA1c <7.0% at 6 months (vs. ≥7.0%) was the strongest predictor of having HbA1c <7.0% at 3 years in both group 1 and 2 (odds ratio [95% confidence interval]: 2.01 [1.77-2.27] and 2.68 [2.10-3.41], respectively). Longer T2D duration was associated with a decreased likelihood of having HbA1c <7.0% at 3 years.

Conclusions: In patients with poor glycaemic control at initiation of second-line therapy, early attainment of HbA1c <7.0% appears predictive of long-term glycaemic control, suggesting that timely modification of treatment strategies in patients with elevated HbA1c after 6 months is important to minimize therapeutic inertia. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/dom.14476DOI Listing
July 2021

Correction to: SGLT2 inhibitors and lower limb complications: an updated meta-analysis.

Cardiovasc Diabetol 2021 Jun 9;20(1):119. Epub 2021 Jun 9.

Department of Endocrinology and Metabolism, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.

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http://dx.doi.org/10.1186/s12933-021-01306-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8191054PMC
June 2021

Urinary C-peptide/creatinine ratio: A useful biomarker of insulin resistance and refined classification of type 2 diabetes mellitus.

J Diabetes 2021 May 29. Epub 2021 May 29.

Departments of Endocrinology and Metabolism, Peking University People's Hospital, Peking University Diabetes Center, Beijing, China.

Background: The urinary C-peptide/creatinine ratio (UCPCR) is low in patients with type 1 diabetes mellitus, but it has not been well characterized in patients with type 2 diabetes mellitus (T2DM). We aimed to measure the UCPCRs in patients with T2DM and explore the relationships among UCPCR, insulin resistance (IR), and chronic vascular complications of diabetes.

Methods: A cross-sectional study was performed of 1299 Chinese hospitalized patients with T2DM. Binary logistic regression was used to evaluate the relationships between the chronic vascular complications of diabetes and UCPCR. K-means analysis was used to allocate participants to subgroups with five to six variables (age at diagnosis, body mass index [BMI], glycosylated hemoglobin, homoeostasis model assessment 2-estimated beta-cell function (HOMA2-B), and HOMA2-insulin resistance (HOMA2-IR), with or without UCPCR).

Results: UCPCR positively correlated with HOMA2-IR (r = 0.448, P < .001). After adjustment for sex, age, duration of diabetes, and other cardiovascular risk factors, UCPCR was positively associated with diabetic kidney disease (DKD) (odds ratio [OR] = 1.198, 95% CI 1.019-1.408, P = .029) and coronary heart disease (CHD) (OR = 1.312, 95% CI 1.079-1.594, P = .006). When UCPCR was added, cluster analysis using the six variables identified five subgroups of T2DM, characterized by differing age at diagnosis, BMI, beta-cell function, IR, and prevalence of vascular complications.

Conclusions: UCPCR is positively associated with IR, DKD, and CHD and represents a promising biomarker that could refine the classification of T2DM.
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http://dx.doi.org/10.1111/1753-0407.13203DOI Listing
May 2021

A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients.

Diabetes Ther 2021 07 29;12(7):1887-1899. Epub 2021 May 29.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

Introduction: China has the world's largest diabetes epidemic and has been facing a serious shortage of primary care providers for chronic diseases including diabetes. To help primary care physicians follow guidelines and mitigate the workload in primary care communities in China, we developed a guideline-based decision tree. This study aimed to validate it at 3 months with real-world data.

Methods: The decision tree was developed based on the 2017 Chinese Type 2 Diabetes (T2DM) guideline and 2018 guideline for primary care. It was validated with the data from two registry studies: the NEW2D and ORBIT studies. Patients' data were divided into two groups: the compliance and non-compliance group, depending on whether the physician's prescription was consistent with the decision tree or not. The primary outcome was the difference of change in HbA1c from baseline to 3 months between the two groups. The secondary outcomes included the difference in the proportion of patients achieving HbA1c < 7% at 3 months between the two groups, the incidence of self-reported hypoglycemia at 3 months, and the proportion of patients (baseline HbA1c ≥ 7%) with a HbA1c reduction ≥ 0.3%. The statistical analysis was performed using linear or logistic regression with inverse probability of treatment weighting with adjustments of confounding factors.

Results: There was a 0.9% reduction of HbA1c in the compliance group and a 0.8% reduction in the non-compliance group (P < 0.001); 61.1% of the participants in the compliance group and 44.3% of the participants in the non-compliance group achieved a HbA1c level < 7% at 3 months (P < 0.001). The hypoglycemic events occurred in 7.1% of patients in the compliance group vs. 9.4% in the non-compliance group (P < 0.001).

Conclusion: The decision tree can help physicians to treat their patients so that they achieve their glycemic targets with fewer hypoglycemic risks. ( http://www.clinicaltrials.gov NCT01525693 & NCT01859598).
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http://dx.doi.org/10.1007/s13300-021-01075-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8266924PMC
July 2021

Generalizability of the Results of Cardiovascular Outcome Trials of Glucagon-Like Peptide 1 Receptor Agonists in Chinese Patients with Type 2 Diabetes Mellitus.

Diabetes Ther 2021 Jul 28;12(7):1861-1870. Epub 2021 May 28.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, 100044, China.

Introduction: This study aimed to investigate the generalizability of the results of cardiovascular outcome trials (CVOTs) of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) to Chinese patients with type 2 diabetes mellitus (T2DM).

Methods: The 3B (Blood Glucose, Blood Pressure, and Blood Lipid) population, a nationally representative population of patients with T2DM in China (n = 25,411), was examined for eligibility of enrollment in four GLP-1 RAs CVOTs (Dulaglutide-REWIND, Exenatide-EXSCEL, Liraglutide-LEADER, and Semaglutide-SUSTAIN-6). We first estimated the proportion of 3B population who would meet the six inclusion and exclusion (I/E) criteria, namely age, hemoglobin A1c (HbA1c), body mass index (BMI), estimated glomerular filtration rate (eGFR), history of cardiovascular disease (CVD), and antidiabetic medication, in each CVOT. Then we compared 11 baseline characteristics, namely age, gender, duration of diabetes, HbA1c, BMI, eGFR, history of CVD, prior myocardial infarction (MI), low-density lipoprotein cholesterol (LDL-c), diastolic blood pressure (DBP), and systolic blood pressure, between the population in each CVOT and the 3B population. Lastly, we estimated the proportion of 3B population that matched the characteristics in each CVOT population.

Results: On the basis of the I/E criteria, 31.1% of the 3B population would have been eligible for enrollment in REWIND, 15.0% for SUSTAIN-6, 12.9% for LEADER, and 11.3% for EXSCEL. On the basis of the baseline characteristics, REWIND most closely matched the 3B population on gender, duration of diabetes, HbA1c, DBP, LDL-c, history of CVD, and prior MI. The proportion of 3B population matching on at least eight or at least ten baseline characteristics with CVOT populations was highest for REWIND compared to other CVOTs.

Conclusion: Among the four GLP-1 RA CVOTs, the REWIND trial using once-weekly dulaglutide is most generalizable to Chinese patients with T2DM.

Trial Registration: Trial registration: NCT01128205 ( www.clinicaltrials.gov ).
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http://dx.doi.org/10.1007/s13300-021-01079-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8266933PMC
July 2021

Towards living guidelines on cardiorenal outcomes in diabetes: A pilot project of the Taskforce of the Guideline Workshop 2020.

Diabetes Res Clin Pract 2021 May 24;177:108870. Epub 2021 May 24.

Forschergruppe Diabetes e. V., Ingolstaedter Landstraße 1, 85764 Neuherberg (Munich), Germany. Electronic address:

In June 2020, the Taskforce of the Guideline Workshop 2019 convened via teleconferencing to initiate a pilot project that demonstrates the various processes and considerations involved in developing high-quality, evidence-based clinical practice guidelines for the medical management of individuals with type 2 diabetes (T2D) and its associated comorbidities, including cardiovascular disease (CVD) and chronic kidney disease (CKD). The goal of the pilot project was to create evidence-based guidelines for use of sodium-glucose transport protein 2 inhibitors (SGLT2-I) when managing very high risk T2D patients, evidenced by the presence of both CVD and CKD. For this purpose the Taskforce represented a guideline panel and made use of synthesized evidence from an ongoing BMJ Rapid Recommendations project on SGLT2-I and GLP-1 receptor agonists. Results from the Taskforce pilot project demonstrated the value, feasibility and utility of using a step-wise approach to identifying and grading evidence and then developing actionable recommendations for utilizing SGLT2-I in this at-risk T2D population. This report describes the various steps involved in the process and explains how it can be utilized to rapidly develop recommendations in a format that is easy to use and can be quickly updated as new evidence becomes available, also within the emerging concept of living guidelines.
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http://dx.doi.org/10.1016/j.diabres.2021.108870DOI Listing
May 2021

A case report of pseudohypoaldosteronism type II with a homozygous KLHL3 variant accompanied by hyperthyroidism.

BMC Endocr Disord 2021 May 22;21(1):103. Epub 2021 May 22.

Department of Endocrinology and Metabolism, Peking University People's Hospital, No 11, Xizhimen Nan Street, Xicheng District, 100044, Beijing, China.

Background: Pseudohypoaldosteronism type II (PHAII), also called Gordon syndrome, is a rare hereditary disease caused by variants in the WNK1, WNK4, KLHL3 and CUL3 genes. The combination of PHAII with hyperthyroidism and secondary hyperparathyroidism has not been reported previously.

Case Presentation: A 54-year-old female with recently diagnosed Graves' disease presented hyperkalemia, hypertension, hypercalciuria, elevated levels of parathyroid hormone (PTH) and normal renal function. PHAII was established based on the finding of a homozygous variant (c.328 A > G, T110A) in the KLHL3 gene. Low-dose thiazide diuretics normalized her potassium, calcium and PTH.

Conclusions: PHAII caused by a KLHL3 variant can affect adults later in life. This diagnosis should be considered in patients with hypertension, consistent hyperkalemia, and normal eGFR and can be corrected by thiazides. The patient also had hyperthyroidism and secondary hyperparathyroidism. The latter was also corrected by thiazide treatment. The hyperthyroidism was assumed to be unrelated to PHAII.
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http://dx.doi.org/10.1186/s12902-021-00767-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141237PMC
May 2021

SGLT2i increased the plasma fasting glucagon level in patients with diabetes: A meta-analysis.

Eur J Pharmacol 2021 Jul 3;903:174145. Epub 2021 May 3.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. Electronic address:

Increased glucagon level was hypothesized to participate in the ketoacidosis associated with sodium-glucose co-transporter 2 inhibitors (SGLT2i) treatment. However, the effect of SGLT2i on glucagon remains controversial. Hence, we conducted this meta-analysis to assess the overall effect of SGLT2i treatment on plasma fasting glucagon level in patients with diabetes. PubMed/MEDLINE, Embase, and Cochrane databases were searched for studies published before August 2020. Clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus with reports of glucagon changes before and after SGLT2i intervention were included. Eligible trials were analyzed by fixed-effect model, random effect model, and meta-regression analysis accordingly. In total, ten trials were included in this meta-analysis. Compared with the non-SGLT2i treatment group, SGLT2i treatment resulted in increased plasma fasting glucagon levels with significance (WMD, 8.35 pg/ml; 95% CI, 2.17-14.54 pg/ml, P<0.01) in patients with diabetes mellitus. Besides, when compared with non-SGLT2i control group, the insulin level decreased (WMD, -2.78 μU/ml; 95% CI, -5.11 to -0.46 μU/ml, P = 0.02) and ketone body level increased (WMD, 0.17 mmol/l; 95% CI, 0.09-0.25 mmol/l, P<0.01) in patients with type 2 diabetes. In conclusion, our result indicated SGLT2i intervention would increase the plasma fasting glucagon level in patients with diabetes mellitus. The increase in plasma fasting glucagon level may be associated with reduced insulin level. The increased glucagon-insulin ratio after the use of SGLT2i may make diabetic patients susceptible to ketosis.
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http://dx.doi.org/10.1016/j.ejphar.2021.174145DOI Listing
July 2021

Effect of empagliflozin on cardiorenal outcomes and mortality according to body mass index: A subgroup analysis of the EMPA-REG OUTCOME trial with a focus on Asia.

Diabetes Obes Metab 2021 Aug 3;23(8):1886-1891. Epub 2021 Jun 3.

Boehringer Ingelheim Norway KS, Asker, Norway.

Aim: To investigate whether the cardiorenal benefits of the sodium-glucose co-transporter-2 inhibitor empagliflozin are affected by body mass index (BMI) in type 2 diabetes patients with established cardiovascular (CV) disease, including Asians.

Methods: In this exploratory analysis of the EMPA-REG OUTCOME trial, we used Cox regression to evaluate the effects of empagliflozin on all-cause mortality, hospitalization for heart failure (HHF) or CV death, and incident or worsening nephropathy by baseline BMI category.

Results: Of the 7020 participants (1517 Asians [21.6%]), 934 (13.3%), 2465 (35.1%) and 3621 (51.6%) had a BMI of less than 25, 25 to less than 30, and 30 kg/m or higher, respectively. Overall, hazard ratios for empagliflozin versus placebo for all-cause mortality, HHF or CV death, and incident or worsening nephropathy were 0.68 (95% CI 0.57, 0.82), 0.66 (0.55, 0.79) and 0.61 (0.53, 0.70), respectively, and were consistent across BMI categories (P values for interaction between treatment and BMI were .6772, .3087 and .6265, respectively). Results were similar in Asians using these BMI categories and categories of less than 24, 24 to less than 28, and 28 kg/m or higher.

Conclusion: Empagliflozin reduced cardiorenal and mortality risk regardless of BMI at baseline, including in Asians with a lower BMI.
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http://dx.doi.org/10.1111/dom.14415DOI Listing
August 2021

Comparison of insulin glargine 300 U/mL versus glargine 100 U/mL on glycemic control and hypoglycemic events in East Asian patients with type 2 diabetes: A Patient-level meta-analysis of phase 3 studies.

Diabetes Res Clin Pract 2021 Jun 1;176:108848. Epub 2021 May 1.

Sanofi, Shanghai, China.

Aims: To evaluate efficacy and safety of Gla-300 with Gla-100 in a patient-level meta-analysis among large East Asian patients with type 2 diabetes mellitus (T2DM).

Methods: A patient level meta-analysis of three EDITION studies with similar design and endpoints were conducted over 6-months treatment period. The analysis included 547 patients treated with Gla-300 and 348 patients treated with Gla-100.

Results: Over 6-month treatment period, mean change in HbA1c was similar for Gla-300 [Least square (LS) mean, (SE): -1.13 (0.05) % and Gla-100: -1.14 (0.05) %], showing non-inferiority of Gla-300 to Gla-100 (LS mean difference: 0.02%, 95% CI: -0.08 to 0.11). Gla-300 was associated with reduced risk of hypoglycemic event (confirmed ≤ 3.9 mmol/L or severe) vs Gla-100 at any time of day or at night (00:00-05:59 h). The event rates of hypoglycemia were consistently lower with Gla-300 than Gla-100. Severe hypoglycemia was rare in both treatment groups. Weight gain was minimal in both treatment groups.

Conclusion: Gla-300 provides comparable glycemic control to Gla-100 in East Asian patients with broad clinical spectrum of T2DM, with consistently less hypoglycemia at any time of the day and night.
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http://dx.doi.org/10.1016/j.diabres.2021.108848DOI Listing
June 2021

Inappropriate intensification of glucose-lowering treatment in older patients with type 2 diabetes: the global DISCOVER study.

BMJ Open Diabetes Res Care 2021 05;9(1)

Institute for Biometrics and Epidemiology, German Diabetes Center Leibniz Institute for Diabetes Research at Heinrich Heine University Düsseldorf, Dusseldorf, Germany.

Introduction: Although individualized target glycated hemoglobin (HbA) levels are recommended in older people with type 2 diabetes, studies report high levels of potential overtreatment. We aimed to investigate the proportion of older patients (aged ≥65 years) who potentially received an inappropriately intensive treatment (HbA level <7.0% (53.0 mmol/mol)) in a global study. Factors associated with intensive glycemic management and using glucose-lowering medications associated with a high risk of hypoglycemia (high-risk medications (insulin, sulfonylureas, and meglitinides)) were also assessed.

Research Design And Methods: DISCOVER is a 3-year observational study program of 15 992 people with type 2 diabetes initiating second-line glucose-lowering therapy in 38 countries. Data were collected at baseline (initiation of second-line therapy) and at 6, 12, and 24 months. Factors associated with an inappropriately intensive treatment or using high-risk medications were assessed using a hierarchical regression model.

Results: Of the 3344 older patients with baseline HbA data in our analytic cohort, 23.5% received inappropriate treatment intensification. Among those who had follow-up HbA data, 55.2%, 54.2%, and 53.5% were inappropriately tightly controlled at 6, 12, and 24 months, respectively, with higher proportions in high-income than in middle-income countries. The proportion of patients receiving high-risk medications was higher in middle-income countries than in high-income countries. Gross national income (per US$5000 increment) was associated with increased odds of inappropriately intensive treatment but with decreased odds of receiving high-risk medications.

Conclusions: A large proportion of older DISCOVER patients received an inappropriately intensive glucose-lowering treatment across the 2 years of follow-up, with substantial regional variation. The use of high-risk medications in these patients is particularly concerning.
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http://dx.doi.org/10.1136/bmjdrc-2020-001585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8098925PMC
May 2021

SGLT2 inhibitors and lower limb complications: an updated meta-analysis.

Cardiovasc Diabetol 2021 04 28;20(1):91. Epub 2021 Apr 28.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

Background: To exam the associations between the use of sodium glucose co-transporter 2 inhibitor (SGLT2i) and the risk of lower limb complications, and to analyze the associated factors.

Methods: Pubmed, Medline, Embase, the Cochrane Center Register of Controlled Trials for Studies and Clinicaltrial.gov were searched from the inception to November 2020. Randomized controlled trials of SGLT2i conducted in population containing diabetic patients with reports of amputation, peripheral arterial disease (PAD) and diabetic foot (DF) events were included. Random-effect model, fixed-effect model and meta-regression analysis were accordingly used.

Result: The numbers of SGLT2i users versus non-SGLT2i users in the analyses of amputation, PAD and DF were 40,925/33,414, 36,446/28,685 and 31,907/25,570 respectively. Compared with non-SGLT2i users, the risks of amputation and PAD were slightly increased in patients with canagliflozin treatment (amputation: OR = 1.60, 95% CI 1.04 to 2.46; PAD: OR = 1.53, 95 % CI 1.14 to 2.05). Meta-regression analyses indicated that greater weight reduction in SGLT2i users was significantly associated with the increased risks of amputation (β = - 0.461, 95% CI - 0.726 to - 0.197), PAD (β = - 0.359, 95% CI - 0.545 to - 0.172) and DF (β = - 0.476, 95% CI - 0.836 to - 0.116). Lower baseline diastolic blood pressure (β = - 0.528, 95% CI - 0.852 to - 0.205), more systolic blood pressure reduction (β = - 0.207, 95% CI - 0.390 to - 0.023) and more diastolic blood pressure reduction (β = - 0.312, 95% CI - 0.610 to - 0.015) were significantly associated with the increased risks of amputation, PAD and DF respectively in patients with SGLT2i treatment.

Conclusions: The risks of amputation and PAD were slightly increased in patients with canagliflozin treatment. Reductions in body weight and blood pressure were associated with lower limb complications in patients with SGLT2i treatment.
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http://dx.doi.org/10.1186/s12933-021-01276-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8082772PMC
April 2021

Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study.

Endocrinol Diabetes Metab 2021 04 20;4(2):e00222. Epub 2021 Jan 20.

Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd. Beijing China.

Introduction: We evaluated the efficacy and safety of teneligliptin compared with placebo when added to metformin therapy in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Methods: This multicentre, randomized, double-blind, placebo-controlled, parallel-group study enrolled type 2 diabetes patients with glycosylated haemoglobin (HbA1c) 7.0%-<10.0% and fasting plasma glucose (FPG) <270 mg/dl, receiving a stable metformin dose ≥1000 mg/day. Teneligliptin 20 mg or placebo was administered orally once daily (qd) before breakfast for 24 weeks. The primary efficacy end-point was change in HbA1c from baseline to Week 24. Safety end-points included the incidence of adverse events (AEs).

Results: The least square mean (LSM) change from baseline (standard error [SE]) was -0.72 (0.07) (95% confidence intervals [CI], -0.87, -0.58) for teneligliptin and -0.01 (0.07) (95% CI, -0.16, 0.13) for placebo. The differences (LSM ± SE) between the placebo and teneligliptin groups in HbA1c and FPG were -0.71% ± 0.11% ( < .0001) and -16.5 ± 4.7 mg/dl ( = .0005), respectively. Teneligliptin yielded significant changes in HbA1c (-0.81%;  < .0001) and FPG (-22.2 mg/dl;  < .0001) at Week 12. At Week 24, more patients achieved HbA1c <7.0% with teneligliptin (41.7%) compared with placebo (16.1%;  < .0001). Treatment-emergent AE incidence was similar with teneligliptin (58.9%) and placebo (68.3%); upper respiratory tract infection, hyperuricaemia and hyperlipidaemia were the most common AEs.

Conclusions: Teneligliptin 20 mg qd for 24 weeks added to ongoing metformin treatment significantly decreased HbA1c and FPG levels compared with placebo in Chinese type 2 diabetes patients. The combination was safe and tolerable.
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http://dx.doi.org/10.1002/edm2.222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8029565PMC
April 2021

Associations between second-line glucose-lowering combination therapies with metformin and HbA1c, body weight, quality of life, hypoglycaemic events and glucose-lowering treatment intensification: The DISCOVER study.

Diabetes Obes Metab 2021 Aug 3;23(8):1823-1833. Epub 2021 May 3.

AstraZeneca, Gaithersburg, Maryland, USA.

Aim: To explore the effects of second-line combination therapies with metformin on body weight, HbA1c and health-related quality of life, as well as the risks of hypoglycaemia and further treatment intensification in the DISCOVER study, a 3-year, prospective, global observational study of patients with type 2 diabetes initiating second-line glucose-lowering therapy.

Materials And Methods: Adjusted changes from baseline in weight, HbA1c and 36-item Short Form Health Survey version 2 (SF-36v2) summary scores at 6, 12, 24 and 36 months were assessed using linear mixed models. Risk of hypoglycaemia and further intensification were assessed using interval censored analyses.

Results: At baseline, 7613 patients received metformin in combination with a sulphonylurea (SU; 40.9%), a dipeptidyl peptidase-4 (DPP-4) inhibitor (48.3%), a sodium-glucose co-transporter-2 (SGLT-2) inhibitor (8.3%) or a glucagon-like peptide-1 (GLP-1) receptor agonist (2.4%). After 36 months, all combinations showed similar reductions in HbA1c (0.8%-1.0%), however, metformin plus a DPP-4 inhibitor, an SGLT-2 inhibitor or a GLP-1 receptor agonist was associated with greater weight loss (1.9, 2.9 and 5.0 kg, respectively) than metformin plus an SU (1.3 kg, P < .0001). Proportions of further treatment intensification were similar across combinations (19.9%-26.2%). Patients prescribed metformin plus an SU more often reported one or more hypoglycaemic events (11.9%) than other combinations (3.9%-6.4%, P < .0001). SF-36v2 summary scores were typically lowest among patients prescribed metformin and an SU.

Conclusions: Combinations of metformin with an SU were associated with the lowest weight reduction, highest risk of hypoglycaemia and lower SF-36v2 scores.
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http://dx.doi.org/10.1111/dom.14400DOI Listing
August 2021

Prevalence and progression of chronic kidney disease among patients with type 2 diabetes: Insights from the DISCOVER study.

Diabetes Obes Metab 2021 Aug 3;23(8):1956-1960. Epub 2021 May 3.

Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.

We report the prevalence and change in severity of chronic kidney disease (CKD) in DISCOVER, a global, 3-year, prospective, observational study of patients with type 2 diabetes (T2D) initiating second-line glucose-lowering therapy. CKD stages were defined according to estimated glomerular filtration rate (eGFR). Overall, 7843 patients from 35 countries had a baseline serum creatinine measurement. Of these (56.7% male; mean age: 58.1 years; mean eGFR: 87.5 mL/min/1.73 m ), baseline prevalence estimates for stage 0-1, 2, 3 and 4-5 CKD were 51.4%, 37.7%, 9.4% and 1.4%, respectively. A total of 5819 patients (74.2%) also had at least one follow-up serum creatinine measurement (median time between measurements: 2.9 years, interquartile range: 1.9-3.0 years). Mean eGFR decreased slightly to 85.7 mL/min/1.73 m over follow-up. CKD progression (increase of ≥1 stage) occurred in 15.7% of patients, and regression (decrease of ≥1 stage) in 12.0%. In summary, a substantial proportion of patients with T2D developed CKD or had CKD progression after the initiation of second-line therapy. Renal function should be regularly monitored in these patients, to ensure early CKD diagnosis and treatment.
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http://dx.doi.org/10.1111/dom.14401DOI Listing
August 2021

Non-Insulin Antidiabetes Treatment in Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

Diabetes Metab J 2021 May 15;45(3):312-325. Epub 2021 Mar 15.

Department of Endocrine and Metabolism, Peking University People's Hospital, Beijing, China.

In order to evaluate the efficacy and side effects of the non-insulin antidiabetes medications as an adjunct treatment in type 1 diabetes mellitus (T1DM), we conducted systematic searches in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials published between the date of inception and March 2020 to produce a systematic review and meta-analysis. Overall, 57 studies were included. Compared with placebo, antidiabetes agents in adjunct to insulin treatment resulted in significant reduction in glycosylated hemoglobin (weighted mean difference [WMD], -0.30%; 95% confidence interval [CI], -0.34 to -0.25%; P<0.01) and body weight (WMD, -2.15 kg; 95% CI, -2.77 to -1.53 kg; P<0.01), and required a significantly lower dosage of insulin (WMD, -5.17 unit/day; 95% CI, -6.77 to -3.57 unit/day; P<0.01). Compared with placebo, antidiabetes agents in adjunct to insulin treatment increased the risk of hypoglycemia (relative risk [RR], 1.04; 95% CI, 1.01 to 1.08; P=0.02) and gastrointestinal side effects (RR, 1.99; 95% CI, 1.61 to 2.46; P<0.01) in patients with T1DM. Compared with placebo, the use of non-insulin antidiabetes agents in addition to insulin could lead to glycemic improvement, weight control and lower insulin dosage, while they might be associated with increased risks of hypoglycemia and gastrointestinal side effects in patients with T1DM.
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http://dx.doi.org/10.4093/dmj.2020.0171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164953PMC
May 2021

Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study.

Diabetologia 2021 May 9;64(5):1066-1078. Epub 2021 Mar 9.

Department of Endocrinology, West China Hospital Sichuan University, Sichuan, China.

Aims/hypothesis: Glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as exenatide are used as monotherapy and add-on therapy for maintaining glycaemic control in patients with type 2 diabetes mellitus. The current study investigated the safety and efficacy of once-weekly PB-119, a PEGylated exenatide injection, in treatment-naive patients with type 2 diabetes.

Methods: In this Phase II, randomised, placebo-controlled, double-blind study, we randomly assigned treatment-naive Chinese patients with type 2 diabetes in a 1:1:1:1 ratio to receive subcutaneous placebo or one of three subcutaneous doses of PB-119 (75, 150, and 200 μg) for 12 weeks. The primary endpoint was the change in HbA from baseline to week 12, and other endpoints were fasting plasma glucose, 2 h postprandial glucose (PPG), and proportion of patients with HbA < 53 mmol/mol (<7.0%) and ≤48 mmol/mol (≤6.5%) at 2, 4, 8 and 12 weeks of treatment. Safety was assessed in all patients who received at least one dose of study drug.

Results: We randomly assigned 251 patients to one of the four treatment groups (n = 62 in placebo and 63 each in PB-119 75 μg, 150 μg and 200 μg groups). At the end of 12 weeks, mean differences in HbA in the treatment groups were -7.76 mmol/mol (95% CI -9.23, -4.63, p < 0.001) (-0.72%, 95% CI -1.01, -0.43), -12.89 mmol/mol (95% CI -16.05, -9.72, p < 0.001) (-1.18%, 95% CI -1.47, -0.89) and -11.14 mmol/mol (95% CI -14.19, -7.97, p <0 .001) (-1.02%, 95% CI -1.30, -0.73) in the 75 μg, 150 μg and 200 μg PB-119 groups, respectively, compared with that in the placebo group after adjusting for baseline HbA. Similar results were also observed for other efficacy endpoints across different time points. There was no incidence of treatment-emergent serious adverse event, severe hypoglycaemia or death.

Conclusions/interpretation: All tested PB-119 doses had superior efficacy compared with placebo and were safe and well tolerated over 12 weeks in treatment-naive Chinese patients with type 2 diabetes.

Trial Registration: ClinicalTrials.gov NCT03520972 FUNDING: The study was funded by National Major Scientific and Technological Special Project for Significant New Drugs Development and PegBio.
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http://dx.doi.org/10.1007/s00125-021-05392-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012337PMC
May 2021

Correlation between OSAHS and Early Peripheral Atherosclerosis Indices in Patients with Type 2 Diabetes Mellitus in China: A Cross-Sectional Inpatient Study.

J Diabetes Res 2021 10;2021:6630020. Epub 2021 Feb 10.

Endocrinology Department, cc, Beijing, China.

Objective: To analyze the differences of early atherosclerosis indices in type 2 diabetes mellitus (T2DM) patients with different degrees of obstructive sleep apnea-hypopnea syndrome (OSAHS) and explore the correlation between them, so as to provide a new clinical basis for the prevention and treatment of early atherosclerosis in patients with T2DM and OSAHS. . A prospective study was conducted in 312 patients with T2DM and snoring who were hospitalized in the Department of Endocrinology, Peking University International Hospital from January 2017 to January 2020. According to the monitoring results, 312 patients were divided into 4 groups including the control group (208 cases), mild OSAHS group (18 cases), moderate OSAHS group (38 cases), and severe OSAHS group (48 cases). Multivariate logistic regression analysis was used to analyze the early atherosclerosis indices including brachial-ankle pulse wave velocity (PWV) and ankle-brachial index (ABI) in patients with T2DM coexistence with different degrees of OSAHS. . (1) As the degree of OSAHS increased, ABI decreased gradually and was lower than that in the control group, but PWV increased and was higher than that in the control group ( < 0.05, respectively). (2) The apnea-hypopnea index (AHI) positively correlated with PWV (r = 0.36, < 0.05) and negatively correlated with ABI ( = -0.37, < 0.05). (3) Multivariate logistic regression showed that after adjusting for age, gender, duration, BMI, blood pressure, blood glucose, blood lipid, and other factors, OSAHS was a risk factor of lower extremity arterial disease (LEAD) in patients with T2DM. With the increase of degree of OSAHS, the risk of lower extremity atherosclerosis gradually increased. . OSAHS is an independent risk factor of LEAD in patients with T2DM, and with the increase of AHI, the ABI and PWV have changed, which provides a new clinical basis for the prevention and the treatment of early atherosclerosis in patients with T2DM and OSAHS.
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http://dx.doi.org/10.1155/2021/6630020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895581PMC
February 2021

A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience.

Diabetes Ther 2021 Mar 22;12(3):931-941. Epub 2021 Feb 22.

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

Introduction: According to Chinese guidelines, basal insulin (BI) or premixed insulins are recommended insulin starters following the failure of oral antihyperglycemic medication (OAM) in Chinese patients with type 2 diabetes (T2D). This pragmatic study investigated the long-term effectiveness, safety, and cost of add-on BI and mid-mixture insulin analog (MMI) regimens in Chinese patients with T2D.

Methods: This multicenter, open-label, pragmatic study randomized patients 1:1 to receive either BI or MMI with OAMs adjusted according to current standards of care. We evaluated the change in glycated hemoglobin (HbA1c) from baseline, safety parameters, and antidiabetic medication costs.

Results: Change in HbA1c from baseline showed a statistically greater decrease at week 48 in the MMI group (MMI: - 2.03% [0.06] vs. BI: - 1.82% [0.06]; P < 0.05). Both groups showed decreases in fasting plasma glucose (mmol/L) (MMI: - 2.53 [0.14] vs. BI: - 3.19 [0.14]; P < 0.01) and postprandial glucose (mmol/L) (MMI: - 4.35 [0.22] vs. BI: - 4.33 [0.23]). More patients in the BI group showed increases in OAM use, while OAM use decreased in the MMI group. Both groups showed stable glycemic control with a very limited insulin dose change from week 24 to week 48. The incidence of total hypoglycemia was higher in the MMI group (MMI: 124% [30.7] vs. BI: 76% [18.5], P < 0.0001), but no incidence of severe hypoglycemia was reported in either group. Treatment costs, in terms of average daily cost and cost of glycemic control, were higher in the BI group.

Conclusion: In long-term real-world use, the MMI and BI groups demonstrated improved glycemic control, with the MMI group showing more significant improvement than the BI group. Hypoglycemia incidence was higher in the MMI group, with no major safety issues through week 48. MMI is likely to provide better price value than BI for the treatment of T2D in Chinese patients.

Trial Registration: ClinicalTrials.gov identifier: NCT03018938.
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http://dx.doi.org/10.1007/s13300-021-01007-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7947078PMC
March 2021

Chinese clinical practice guidelines for perioperative blood glucose management.

Diabetes Metab Res Rev 2021 Jan 21:e3439. Epub 2021 Jan 21.

Department of Endocrinology, the First Medical Center, Chinese PLA General Hospital, Beijing, China.

With the increased incidence of diabetes, the number of diabetic patients who require surgical treatment is also increasing. Unfortunately, practices in this area lack standardisation. The purpose of this multidisciplinary, evidence-based guidelines for perioperative blood glucose management is to provide a comprehensive set of recommendations for clinicians treating diabetes with different types of surgery. The intended audience comprises Chinese endocrinologists, surgeons, anaesthetists, clinical pharmacists, nurses and professionals involved in perioperative blood glucose management. The guidelines were formulated as follows. First, a multidisciplinary expert group was established to identify and formulate key research questions on topics of priority according to the Population, Intervention, Comparator and Outcomes (PICO) process. We conducted a meta-analysis of available studies using Review Manager version 5.3, as appropriate. We pooled crude estimates as odds ratios with 95% confidence intervals using a random-effects model, and used the Grading of Recommendations Assessment, Development, and Evaluation methods to assess the quality of the retrieved evidence. Finally, 32 recommendations were gathered that covered 11 fields-management and coordination, endocrinologists' consultation, diabetes diagnosis, surgery timing and anaesthesia method, blood glucose target values and monitoring frequency, hypoglycaemia treatment, oral administration of blood glucose lowering drugs, use of insulin, enteral and parenteral nutritional, postoperative treatment and medication and education and training. Twenty-five systematic reviews and meta-analyses were conducted for these guidelines to address the PICO questions. These guidelines are intended to improve perioperative blood glucose management and help doctors in specifying medical diagnosis and treatment, and will be implemented / disseminated extensively in China.
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http://dx.doi.org/10.1002/dmrr.3439DOI Listing
January 2021

Association between non-alcoholic fatty liver disease and diabetes-related microvascular complications: A retrospective cross-sectional study of hospitalized patients.

Endocr Pract 2021 Feb 15. Epub 2021 Feb 15.

Department of Endocrinology and Metabolism, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing 100044, China. Electronic address:

Objective: Owing to limited research, the effect of non-alcoholic fatty liver disease (NAFLD) on type 2 diabetes outcomes remains unclear. This study aimed to investigate the association between NAFLD and microvascular complications in hospitalized patients with type 2 diabetes.

Methods: We included 1982 patients with type 2 diabetes. NAFLD was defined as hepatic steatosis detected by ultrasound without secondary causes of fat accumulation. The diagnosis of diabetic retinopathy (DR), diabetic kidney disease (DKD) and diabetic neuropathy was based on clinical medical records. Risk for advanced liver fibrosis was categorized as "low risk," "indeterminate risk," and "high risk," based on the NAFLD Fibrosis Score (NAFLD-FS). Logistic regression was used to test the association between NAFLD, risk for advanced fibrosis and the presence of DR, DKD, and diabetic neuropathy.

Results: The prevalence of NAFLD was 61.3%. The presence of DR (odds ratio [OR]: 0.749, 95% confidence interval [CI]: 0.578-0.971), and DKD (OR: 0.667, 95% CI: 0.515-0.864) was inversely associated with NAFLD, after adjusting for covariates. The presence of DR and DKD was higher in the "indeterminate risk" (DR: OR: 1.237, 95% CI: 0.730-2.096; DKD: OR: 1.009, 95% CI: 0.640-1.591, respectively) and "high risk" group (DR: OR: 1.341, 95% CI: 0.730-2.463; DKD: OR: 1.732, 95% CI: 1.021-2.940, respectively) than in the "low risk" group, after adjusting for the same covariates. Only the presence of DKD significantly increased with high NAFLD-FS (P=0.01 for trend).

Conclusion: The presence of DR and DKD was inversely associated with NAFLD among hospitalized patients with type 2 diabetes. DKD was closely associated with high NAFLD-FS among patients with NAFLD.
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http://dx.doi.org/10.1016/j.eprac.2021.02.004DOI Listing
February 2021

Type 2 diabetes and heart failure: insights from the global DISCOVER study.

ESC Heart Fail 2021 04 11;8(2):1711-1716. Epub 2021 Feb 11.

Saint Luke's Mid America Heart Institute, 4401 Wornall Rd, Kansas City, MO, 64111, USA.

Aims: Heart failure (HF) is increasingly recognized as a major cause of morbidity and mortality in patients with type 2 diabetes (T2D), but the global epidemiology and treatment of HF in T2D are not well defined. This study aimed to examine the global prevalence of HF and the incidence of HF over 3 years of follow-up in patients with T2D [by presence and absence of co-existing coronary artery disease (CAD)].

Methods And Results: DISCOVER was a 3 year, prospective, observational study of T2D patients enrolled at initiation of second-line glucose-lowering therapy. Among 14 057 patients with T2D from 36 countries, 289 (2.1%) had a diagnosis of HF at enrolment; median prevalence across countries was 2.0% (inter-quartile range 1.0-3.1%). Patients with HF at baseline were more likely to be older [HF vs. no HF: 67 ± 12 vs. 57 ± 12 years, standardized difference (StDiff) = 84%] and have longer duration of T2D (8.1 ± 7.2 vs. 5.6 ± 5.2 years, StDiff = 40%), CAD (44% vs. 6%, StDiff = 97%), atrial fibrillation (21% vs. 1%, StDiff = 66%), and kidney disease (23% vs. 4%, StDiff = 55%). Patients with HF were less likely to be on metformin (66% vs. 79%, StDiff = 28%) and thiazolidinediones (5.5% vs. 10.6%, StDiff = 19%) but had similar use of other glucose-lowering medications. Among 9313 patients with follow-up data, there were 70 incident cases of HF, which translates to an incidence of 2.6 cases per 1000 person years. Of these incident HF cases, 60% occurred in the absence of pre-existing or concomitant CAD, and 73% were diagnosed in the outpatient setting.

Conclusions: In a large, global cohort of patients with T2D, the majority of incident cases of HF occurred in outpatients and in the absence of known CAD. These findings highlight the need for greater awareness of HF risk in patients with T2D.
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http://dx.doi.org/10.1002/ehf2.13235DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006680PMC
April 2021

Sex differences in the prevalence of obesity in 800,000 Chinese adults with type 2 diabetes.

Endocr Connect 2021 Feb;10(2):139-145

Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

Aims: To estimate the sex differences in the prevalence of overweight and obesity aged 20-89 in Chinese patients with type 2 diabetes (T2D).

Methods: 811,264 patients with T2D from six hospital-based, cross-sectional studies, and 46,053 subjects from the general population were included in our analysis. Prevalence of underweight, overweight, obesity were calculated in each sex.

Results: In patients with T2D, the standardized prevalence of underweight (BMI <18.5 kg/m2), overweight (24 kg/m2 ≤ BMI < 28 kg/m2), and general obesity (BMI ≥28 kg/m2) were 2.2%, 43.2%, and 11.6%, respectively. Similar trend patterns of the prevalence of underweight and overweight were observed in general and T2D population, in males and females with T2D (all P for trend <0.01). In patients with T2D, patients at a younger age and older age were more likely to be underweight. The prevalence of overweight increased first, then stabilized or decreased with age. However, different trend patterns of the prevalence of obesity in males and females were found. In males, the prevalence of obesity decreased first, and then stabilized after 60 years of age. In females, the prevalence of obesity decreased first, then increased after 50 years of age. In the general population, the prevalence of obesity increased with age in females, while, the trend of prevalence of obesity with age in males was not obvious.

Conclusion: Different trends in the prevalence of obesity with age in different sex were found in Chinese patients with T2D.
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http://dx.doi.org/10.1530/EC-20-0547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983479PMC
February 2021

Serum Ratio of Free Triiodothyronine to Thyroid-Stimulating Hormone: A Novel Index for Distinguishing Graves' Disease From Autoimmune Thyroiditis.

Front Endocrinol (Lausanne) 2020 8;11:620407. Epub 2021 Jan 8.

Departments of Endocrinology and Metabolism, Peking University People's Hospital, Peking University Diabetes Center, Beijing, China.

Objective: Graves' disease (GD) and autoimmune thyroiditis (AIT) are two major causes of thyrotoxicosis that require correct diagnosis to plan appropriate treatment. The objectives of this study were to evaluate the usefulness of thyroid-related parameters for distinguishing GD from AIT and identify a novel index for differential diagnosis of thyrotoxicosis.

Design: This retrospective study was performed using electronic medical records in Peking University People's Hospital (Beijing, China).

Methods: In total, 650 patients with GD and 155 patients with AIT from December 2015 to October 2019 were included in cohort 1. Furthermore, 133 patients with GD and 14 patients with AIT from December 2019 to August 2020 were included in cohort 2 for validation of the novel index identified in cohort 1. All patients were of Chinese ethnicity and were newly diagnosed with either GD or AIT. Thyroid-related clinical information was collected before intervention by reviewing the patients' electronic medical records. Receiver operating characteristic curve analysis was used to identify the optimal cutoff for distinguishing GD from AIT.

Results: In cohort 1, thyroid-stimulating hormone (TSH) receptor antibody was identified as the best indicator for distinguishing GD from AIT. The area under the receiver operating characteristic curve was 0.99(95% confidence interval: 0.98-0.99, p<0.0001)and the optimal cutoff was 0.84 IU/l (98% sensitivity and 99% specificity). The free triiodothyronine (FT3)/TSH ratio (FT3/TSH) was the second -best for distinguishing GD from AIT, the area under the receiver operating characteristic curve of FT3/TSH was 0.86 (95% confidence interval: 0.84-0.88, p<0.0001); its optimal cutoff was 1.99 pmol/mIU (79% sensitivity and 80% specificity). Its effectiveness was confirmed in cohort 2 (81% sensitivity and 100% specificity).

Conclusions: The FT3/TSH ratio is a new useful index for differential diagnosis of thyrotoxicosis, especially when combined with TRAb.
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http://dx.doi.org/10.3389/fendo.2020.620407DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821852PMC
May 2021

Retracted: Western pacific consensus proposals for management of prediabetes.

Int J Clin Pract 2021 Jan 22:e14019. Epub 2021 Jan 22.

Vietnamese Association of Diabetes and Endocrinology, Hochiminh, Vietnam.

Prediabetes and diabetes burden become the strong challenge in the Western Pacific region. Prediabetes with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and the mixed status (IFG + IGT) are considered as risk factors for the development of diabetes. Effective early intervention for prediabetes can significantly delay the progression of the onset of diabetes, even if reverse blood glucose to normal. Increasing evidence shows that without targeted intervention, the progression from prediabetes to diabetes occurs more frequently in Asians compared with Caucasians. Consequently, it is essential to timely detect the populations at higher risk and effectively implement intervention and management to prevent diabetes. Significant evidence also supports the effectiveness of adjusting lifestyle in combination with medication to delay the onset of diabetes. A working group of Western Pacific expertise in diabetes conducted to develop evidence-based consensus recommendations to guide the management of patients with prediabetes. These consensual recommendations are intended to provide a clear and concise approach to the management of individuals with prediabetes.
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http://dx.doi.org/10.1111/ijcp.14019DOI Listing
January 2021