Conditions: Type 2 Diabetes
Keywords: Dapagliflozin efficacy safety sulphonylurea Type 2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 597
Healthy volunteers: no

Brief summary:
This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Detailed description:

Arms:
arm 1: dapagliflozin 2.5mg + Glimepiride arm 2: dapagliflozin 5mg + Glimepiride arm 3: dapagliflozin 10mg + Glimepiride arm 4: Placebo + Glimepiride

Interventions: intervention 1: dapagliflozin intervention 2: Glimepiride intervention 3: metformin hydrochloride intervention 4: pioglitazone hydrochloride intervention 5: Rosiglitazone
Intervention descriptions: intervention 1: tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks intervention 2: tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks intervention 3: rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice intervention 4: rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice intervention 5: rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Protocol document: