A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea

AstraZeneca1 site in 1 country311 target enrollmentOctober 2011

ConditionsType 2 Diabetes Mellitus High HbA1c Level Inadequate Glycaemic Control

Interventionsdapagliflozin placebo

Drugsdapagliflozin placebo

Overview

Phase: Phase 3
Intervention: dapagliflozin
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 311
Locations: 1
Primary Endpoint: Adjusted Mean Change From Baseline in HbA1c Levels
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

August 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes mellitus
•Men or women age ≥ 18 years old
•Stable dose combination of metformin and sulfonylurea
•HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria

•Type 1 diabetes mellitus or diabetes insipidus
•Recent cardiovascular events
•Kidney or urological disorders
•Hepatic disorders

Arms & Interventions

Dapagliflozin 10 mg tablet

Intervention: dapagliflozin

matching placebo tablet

Intervention: placebo

Outcomes

Primary Outcomes

Adjusted Mean Change From Baseline in HbA1c Levels

Time Frame: Baseline to week 24

To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.

Secondary Outcomes

Adjusted Mean Change From Baseline in FPG(Baseline to week 24)
Adjusted Mean Change From Baseline in Total Body Weight(Baseline to week 24)
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)(Baseline to week 24)
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure(Baseline to week 8)