Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Exenatide Diabetes drug Treatment efficacy Placebo Metabolism Cardiovascilar metabolic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 464
Healthy volunteers: no

Brief summary:
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Detailed description:

Arms:
arm 1: Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin arm 2: Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin

Interventions: intervention 1: Exenatide intervention 2: Exenatide matching placebo
Intervention descriptions: intervention 1: 2 mg weekly suspension injection intervention 2: Once weekly Placebo injection

Protocol document: