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

Phase 3

Completed

Conditions: Cardiovascular Disease
Type 2 Diabetes Mellitus
Inadequate Glycaemic Control

Brief Summary: This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's 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 and cardiovascular disease

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
2	Placebo	matching placebo tablet
1	Dapagliflozin	dapagliflozin 10 mg 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, 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 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 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.
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 Change in Systolic Blood Pressure at Week 8 (LOCF)	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.
Adjusted Mean Change in Seated Systolic Blood Pressure 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.
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg	Baseline to Week 8	To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.