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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide once weekly

Drug: exenatide twice daily

Study type

Interventional

Funder types

Industry

Identifiers

NCT00917267

H8O-MC-GWCK

Details and patient eligibility

About

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.

Enrollment

691 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.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