Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Exenatide Dapagliflozin Diabetes medication Treatment efficacy Placebo Metabolism Cardiovascular metabolic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 695
Healthy volunteers: no

Brief summary:
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Detailed description:

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

Interventions: intervention 1: Exantide with Dapagliflozin intervention 2: Exentide intervention 3: Dapagliflozin
Intervention descriptions: intervention 1: 2 mg weekly suspension injection and 10 mg Dapagliflozin intervention 2: 2 mg intervention 3: 10 mg once daily Dapagliflozin

Protocol document: