Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Information source: Amylin Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: exenatide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amylin Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company
Summary
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic
(OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.
Clinical Details
Official title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.
Secondary outcome: To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Treated with a stable dose of one of the following for at least 3 months prior to
screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and
sulfonylurea; or sulfonylurea/metformin combination therapy.
- HbA1c between 7. 1% and 11. 0%, inclusive.
- Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2.
Exclusion Criteria:
- Have participated in this study previously, or any other study using exenatide or
GLP-1 analogs.
- Have participated in an interventional, medical, surgical, or pharmaceutical study
within 30 days of screening.
- Have characteristics contraindicating metformin or sulfonylurea use.
- Have been treated with exogenous insulin for more than 1 week within the 3 months
prior to screening.
- Have used drugs for weight loss within 1 month of screening.
Locations and Contacts
Research Site, Beijing, China
Research Site, Guangzhou, China
Research Site, Nanjing, China
Research Site, Shanghai, China
Research Site, Sichuan, China
Research Site, Pune, India
Research Site, Chennai, India
Research Site, Mumbai, India
Research Site, Seoul, Korea, Republic of
Research Site, Sungnam City, Korea, Republic of
Research Site, Taipei, Taiwan
Research Site, Chiayi, Taiwan
Research Site, Taichung, Taiwan
Research Site, Tainan, Taiwan
Additional Information
Starting date: January 2006
Ending date: September 2007
Last updated: October 31, 2007
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