A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Have been diagnosed with type 2 diabetes.

• Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.

• Have a body mass index (BMI) of >21 kg/m2 and <35 kg/m2, inclusive.

• Have a history of stable body weight (not varying by >5% for at least 90 days prior to study start).

• Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.

Exclusion Criteria:

• Have any contraindication for the OAD(s) that they use.

• Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.

• Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.

• Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.

• Have been treated for >2 weeks with any of the following excluded medications within 90 days prior to study start:

• Insulin

• Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)

• Pramlintide acetate

• Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.

• Have had prior exposure to exenatide

• Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

• Are currently enrolled in any other clinical study.