Conditions: Type 2 Diabetes
Keywords: Dapagliflozin efficacy safety add on to insulin Oral AntiDiabetic Type 2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1240
Healthy volunteers: no

Brief summary:
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Detailed description:

Arms:
arm 1: 2.5mg arm 2: 5mg arm 3: 10mg arm 4: None

Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Dapagliflozin intervention 4: Placebo intervention 5: Dapagliflozin intervention 6: Dapagliflozin
Intervention descriptions: intervention 1: tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 2: Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 3: Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 4: Placebo intervention 5: tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II) intervention 6: tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Protocol document: