Official Title: “Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)”

This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: exenatide
  • subcutaneous injection (5mcg or 10mcg), twice a day
• Drug: glimepiride
  • oral tablet (titrated to maximally tolerated dose), once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A
• Active Comparator: Group B

Primary Measures

• To test the hypothesis that exenatide injected twice daily is non-inferior to glimepiride given once-daily before breakfast to patients with type 2 diabetes.
  • Time Frame: open ended
    Safety Issue?: No

Secondary Measures

• To compare the effects of exenatide and glimepiride on beta-cell function.
  • Time Frame: open ended
    Safety Issue?: No
• To compare the effects of exenatide and glimepiride on various pharmacodynamic measures.
  • Time Frame: open ended
    Safety Issue?: No
• To compare the safety and tolerability of exenatide and glimepiride.
  • Time Frame: open ended
    Safety Issue?: No
• To compare the effects of exenatide and glimepiride on the occurrence of hypoglycemic episodes.
  • Time Frame: open ended
    Safety Issue?: No
• To study the efficacy and safety of different treatment options.
  • Time Frame: open ended
    Safety Issue?: No
• To study the level of anti-exenatide antibodies in patients randomized to exenatide.
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Diagnosed with type 2 diabetes mellitus.
• Treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening.
• HbA1c >=6.5% and <=9.0%.
• Body Mass Index (BMI) >=25 kg/m^2 and <40 kg/m^2.

Exclusion Criteria:

• Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening.
• Characteristics contraindicating metformin or glimepiride use.
• Receiving drugs that directly affect gastrointestinal motility.
• Receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy.
• Have used any prescription drug to promote weight loss within 3 months prior to screening.
• Treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: *insulin; *thiazolidinediones; *alpha-glucosidase inhibitors;
• *sulfonylurea; *meglitinides

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Amylin Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

James Malone, MD Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00359762

Study ID Number: H8O-EW-GWBE

ClinicalTrials.gov Identifier: NCT00359762

Health Authority: Austria: Federal Ministry for Health and Women