Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta Amylin Lilly
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: no

Brief summary:
This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.

Detailed description:

Arms:
arm 1: A single 10-mg dose of exenatide once weekly suspension given to healthy participants via 3 subcutaneous (SC) injections at Day 1. arm 2: On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. arm 3: On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks.

Interventions: intervention 1: exenatide once weekly intervention 2: exenatide once weekly intervention 3: Placebo
Intervention descriptions: intervention 1: subcutaneous injection, 10.0 mg, single injection intervention 2: subcutaneous injection, 2.0 mg, once a week for 12 weeks intervention 3: subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks

Protocol document: