A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment.

Authors:
Dr Paul Norwood, MD
Dr Paul Norwood, MD
University of California at San Francisco
Associate Clinical Professor of Medicine at UC San Francisco
Diabetes, cholesterol, hypertension,
Fresno, CA | United States
Arnaud Bastien
Arnaud Bastien
and Blood Institute
United States
James F List
James F List
Howard Hughes Medical Institute
United States
Fred T Fiedorek
Fred T Fiedorek
Scripps Clinic
United States

Diabetes Care 2009 Sep 15;32(9):1656-62. Epub 2009 Jun 15.

University of Liverpool, School of Clinical Sciences, Liverpool, England.

Objective: To determine whether dapagliflozin, which selectively inhibits renal glucose reabsorption, lowers hyperglycemia in patients with type 2 diabetes that is poorly controlled with high insulin doses plus oral antidiabetic agents (OADs).

Research Design And Methods: This was a randomized, double-blind, three-arm parallel-group, placebo-controlled, 26-center trial (U.S. and Canada). Based on data from an insulin dose-adjustment setting cohort (n = 4), patients in the treatment cohort (n = 71) were randomly assigned 1:1:1 to placebo, 10 mg dapagliflozin, or 20 mg dapagliflozin, plus OAD(s) and 50% of their daily insulin dose. The primary outcome was change from baseline in A1C at week 12 (dapagliflozin vs. placebo, last observation carried forward [LOCF]).

Results: At week 12 (LOCF), the 10- and 20-mg dapagliflozin groups demonstrated -0.70 and -0.78% mean differences in A1C change from baseline versus placebo. In both dapagliflozin groups, 65.2% of patients achieved a decrease from baseline in A1C > or =0.5% versus 15.8% in the placebo group. Mean changes from baseline in fasting plasma glucose (FPG) were +17.8, +2.4, and -9.6 mg/dl (placebo, 10 mg dapagliflozin, and 20 mg dapagliflozin, respectively). Postprandial glucose (PPG) reductions with dapagliflozin also showed dose dependence. Mean changes in total body weight were -1.9, -4.5, and -4.3 kg (placebo, 10 mg dapagliflozin, and 20 mg dapagliflozin). Overall, adverse events were balanced across all groups, although more genital infections occurred in the 20-mg dapagliflozin group than in the placebo group.

Conclusions: In patients receiving high insulin doses plus insulin sensitizers who had their baseline insulin reduced by 50%, dapagliflozin decreased A1C, produced better FPG and PPG levels, and lowered weight more than placebo.

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Source
http://dx.doi.org/10.2337/dc09-0517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2732143PMC

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September 2009
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