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Exenatide Versus Glimepiride in Patients With Type 2 Diabetes

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Patients With Treatment Failure

Time to Treatment Failure

Secondary outcome:

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3

Change in HOMA-B From Baseline to Endpoint

Fasting Proinsulin/Insulin Ratio at Year 3

Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.

Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3

Change in DI30/DG30 Ratio From Baseline to Endpoint

Disposition Index at Year 3

Change in Disposition Index From Baseline to Endpoint

Change in HbA1c From Baseline to Year 3

Change in HbA1c From Baseline to Endpoint

Fasting Plasma Glucose at Year 3

Change in Fasting Plasma Glucose From Baseline to Endpoint

Postprandial (2 Hours) Plasma Glucose at Year 3

Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint

Change in Body Weight From Baseline to Year 3

Systolic Blood Pressure at Year 3

Diastolic Blood Pressure at Year 3

Heart Rate at Year 3

Triglycerides at Year 3

Total Cholesterol at Year 3

High-density Lipoprotein (HDL) Cholesterol at Year 3

Hypoglycemia Rate Per Year

Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III

Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III

Hypoglycemia Rate Per Year in Period III

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

Research Site, Graz, Austria

Research Site, Innsbruck, Austria

Research Site, Salzburg, Austria

Research Site, Vienna, Austria

Research Site, Beroun, Czech Republic

Research Site, Ceske Budejovice, Czech Republic

Research Site, Hradec Kralove, Czech Republic

Research Site, Liberec, Czech Republic

Research Site, Pisek, Czech Republic

Research Site, Praha, Czech Republic

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Research Site, Alencon, France

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Research Site, Aschaffenburg, Germany

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Research Site, Celaya, Guanajuato, Mexico

Research Site, Pachuca, Hidalgo, Mexico

Research Site, Monterrey, Nuevo Leon, Mexico

Additional Information

Starting date: September 2006
Last updated: May 26, 2015

Page last updated: August 23, 2015

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