Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• At least 18 years old

• Diagnosed with type 2 diabetes mellitus

• HbA1c 7.1 to 11%, inclusive, at screening

• Fasting plasma glucose <280 mg/dL (15.5 mmol/L)

• Body mass index (BMI) <=45 kg/m2, inclusive, at screening

• Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria:

• History of pancreatitis or triglycerides >=500 mg/dL

• Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either

• Active cardiovascular disease

• Presence of congestive heart failure

• Liver disease

• History of severe gastrointestinal diseases

• Repeated severe hypoglycemia within the last 6 months

• Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog

• Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months