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Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial.

ABSTRACT: Dapagliflozin, a highly selective inhibitor of the renal sodium-glucose cotransporter-2, increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner. We evaluated the efficacy and safety of dapagliflozin in treatment-naive patients with type 2 diabetes.This was a 24-week parallel-group, double-blind, placebo-controlled phase 3 trial. Patients with A1C 7.0-10% (n = 485) were randomly assigned to one of seven arms to receive once-daily placebo or 2.5, 5, or 10 mg dapagliflozin once daily in the morning (main cohort) or evening (exploratory cohort). Patients with A1C 10.1-12% (high-A1C exploratory cohort; n = 73) were randomly assigned 1:1 to receive blinded treatment with a morning dose of 5 or 10 mg/day dapagliflozin. The primary end point was change from baseline in A1C in the main cohort, statistically tested using an ANCOVA.In the main cohort, mean A1C changes from baseline at week 24 were -0.23% with placebo and -0.58, -0.77 (P = 0.0005 vs. placebo), and -0.89% (P < 0.0001 vs. placebo) with 2.5, 5, and 10 mg dapagliflozin, respectively. Signs, symptoms, and other reports suggestive of urinary tract infections and genital infection were more frequently noted in the dapagliflozin arms. There were no major episodes of hypoglycemia. Data from exploratory cohorts were consistent with these results.Dapagliflozin lowered hyperglycemia in treatment-naive patients with newly diagnosed type 2 diabetes. The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for type 2 diabetes.

SUBMITTER: Ferrannini E

PROVIDER: S-EPMC2945163 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial.

Ferrannini Ele E Ramos Silvia Jimenez SJ Salsali Afshin A Tang Weihua W List James F JF

Diabetes care 20100621 10

<h4>Objective</h4>Dapagliflozin, a highly selective inhibitor of the renal sodium-glucose cotransporter-2, increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner. We evaluated the efficacy and safety of dapagliflozin in treatment-naive patients with type 2 diabetes.<h4>Research design and methods</h4>This was a 24-week parallel-group, double-blind, placebo-controlled phase 3 trial. Patients with A1C 7.0-10% (n = 485) were randomly assigned to one ...[more]

PMID: 20566676

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Project description:IntroductionMaintenance of drug efficacy and safety over the long term is important to investigate for progressive conditions like type 2 diabetes mellitus (T2DM). This study aimed to evaluate whether efficacy of dapagliflozin added to glimepiride observed at 24 weeks was maintained at 48 weeks, and to provide further safety and tolerability data in patients with T2DM.MethodsThis 24-week randomized, double-blind, parallel-group, placebo-controlled trial with a 24-week double-blind extension period enrolled adults whose T2DM was inadequately controlled [glycated hemoglobin (HbA1c) 7.0-10.0%] on sulfonylurea monotherapy. Patients were randomized to placebo (n = 146) or dapagliflozin 2.5 mg (n = 154), 5 mg (n = 145), or 10 mg (n = 151) per day added to open-label glimepiride 4 mg/day.ResultsIn total, 519 patients (87.1%) completed the study. At 48 weeks, HbA1c adjusted mean changes from baseline for the placebo versus dapagliflozin 2.5/5/10-mg groups were -0.04% versus -0.41%, -0.56% and -0.73%, respectively. There were no meaningful differences in HbA1c changes from baseline from 24 to 48 weeks, indicating that glycemic efficacy was maintained. Improvements in fasting plasma glucose and post-challenge plasma glucose were also observed with dapagliflozin over 48 weeks. Dapagliflozin 2.5/5/10 mg produced sustained reductions in weight (-1.36/-1.54/-2.41 kg) versus placebo (-0.77 kg). Adjusted mean reductions from baseline in systolic blood pressure were also greater than placebo for all dapagliflozin doses. In the placebo versus dapagliflozin groups, serious adverse events were 8.9% versus 8.6-11.0%, hypoglycemic events were 6.8% versus 9.7-11.3%, and events suggestive of genital infection were 1.4% versus 5.2-8.6%.ConclusionDapagliflozin added to glimepiride improved glycemic control and body weight, with short-term findings maintained during the study's extension period. Therapy was generally well tolerated over 48 weeks; hypoglycemic events and events suggestive of genital infection were reported more often in patients receiving dapagliflozin.

Dataset Information

Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial.

Publications

Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial.

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