Status:
COMPLETED
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 pop...
Eligibility Criteria
Inclusion
- 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
- 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- Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
691 Patients enrolled
Trial Details
Trial ID
NCT00917267
Start Date
July 1 2009
End Date
April 1 2011
Last Update
April 9 2015
Active Locations (42)
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1
Research Site
Beijing, China
2
Research Site
Chengdu, China
3
Research Site
Chongqin, China
4
Research Site
Guangzhou, China