Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Inadequate Glycaemic Control; Cardiovascular Disease; Hypertension
• Interventions: Drug: Dapagliflozin; Drug: Placebo

• Registration Number: NCT01031680
• Lead Sponsor: AstraZeneca

Brief Summary

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Study Start: 2010-02
• Primary Completion: 2011-05
• Study Completion: 2012-12
• Results First Submitted: 2013-01-21
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-08-23
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 922

Inclusion Criteria

• Type 2 diabetes mellitus.
• Cardiovascular disease
• Hypertension

Exclusion Criteria

• Patients with type 1 diabetes or diabetes insipidus
• Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
• Any clinically significant illness, which would compromise the patient's safety and their participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dapagliflozin	Dapagliflozin 10 mg tablet
2	Placebo	Matching placebo tablet

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c Levels	Baseline to Week 24	To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit	Baseline to week 24	To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)	Baseline to Week 24	To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²	Baseline to Week 24	To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.
Adjusted Mean Percent Change in Body Weight	Baseline to Week 24	To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)	Baseline to Week 8	To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam