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Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

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); glimepiride (Drug)

Phase: Phase 3

Status: Active, not recruiting

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

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome:

To compare the effects of exenatide and glimepiride on beta-cell function.

To compare the effects of exenatide and glimepiride on various pharmacodynamic measures.

To compare the safety and tolerability of exenatide and glimepiride.

To compare the effects of exenatide and glimepiride on the occurrence of hypoglycemic episodes.

To study the efficacy and safety of different treatment options.

To study the level of anti-exenatide antibodies in patients randomized to exenatide.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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Additional Information

Starting date: September 2006
Ending date: December 2009
Last updated: December 18, 2007

Page last updated: June 20, 2008

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