Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Exenatide; Metformin

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks

• Hemoglobin A1c (HbA1c) 7% to 10% at screening

• Body mass index (BMI) < or = to 45 kg/m2

Exclusion Criteria:

• History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening

• History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening

• History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study

• History of prescription or over the counter weight loss medication during 3 months prior to screening

• Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening