Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2996
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

Detailed description:

Arms:
arm 1: Oral tablets administered as 10 mg once daily for up to 12 weeks arm 2: Oral tablets administered once daily in the morning arm 3: Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8) arm 4: Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)

Interventions: intervention 1: Dapagliflozin intervention 2: Placebo-matching dapagliflozin
Intervention descriptions: intervention 1: Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks intervention 2: Oral tablets administered as 0 mg once daily for up to 12 weeks

Protocol document: