Conditions: Type 2 Diabetes Mellitus Cardiovascular Disease Hypertension Inadequate Glycaemic Control
Keywords: dapagliflozin diabetes cardiovascular disease hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 922
Healthy volunteers: no

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:

Arms:
arm 1: Dapagliflozin 10 mg tablet arm 2: Matching placebo tablet

Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period intervention 2: Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Protocol document: