Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; High HbA1c Level; Inadequate Glycaemic Control
• Interventions: Drug: dapagliflozin; Drug: placebo

• Registration Number: NCT01392677
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Study Start: 2011-10
• Primary Completion: 2013-01
• Study Completion: 2013-08
• Results First Submitted: 2013-11-05
• Results First Submitted QC: 2013-11-05
• Results First Posted: 2013-12-27
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin 10 mg tablet	dapagliflozin	-
matching placebo tablet	placebo	-

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in HbA1c Levels	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 Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in FPG	Baseline to week 24	To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
Adjusted Mean Change From Baseline in Total Body Weight	Baseline to week 24	To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)	Baseline to week 24	To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, at week 24 (LOCF) between dapagliflozin and placebo
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure	Baseline to week 8	To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo

Trial Locations

Locations (1)

Research Site; 🇪🇸 Sta Coloma de Gramenet (BCN), Spain