Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 631
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Detailed description:
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, Once Daily, 104 weeks intervention 2: Tablets, Oral, 5 mg, Once Daily, 104 weeks intervention 3: Tablets, Oral, 0 mg, Once Daily, 104 weeks

Protocol document: