Exenatide Versus Glimepiride in Patients With Type 2 Diabetes - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00359762

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide Drug: glimepiride	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	1054
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	Drug: exenatide subcutaneous injection (5mcg or 10mcg), twice a day Other Name: Byetta
Active Comparator: Group B	Drug: glimepiride oral tablet (titrated to maximally tolerated dose), once daily Other Name: Amaryl

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359762

Show 141 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	James Malone, MD, Study Director, Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00359762 History of Changes
Other Study ID Numbers:	H8O-EW-GWBE
Study First Received:	July 31, 2006
Last Updated:	May 4, 2010
Health Authority:	Austria: Federal Ministry for Health and Women Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Israel: Israeli Health Ministry Pharmaceutical Administration Italy: The Italian Medicines Agency Mexico: Ministry of Health Poland: Ministry of Health Spain: Spanish Agency of Medicines Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

exenatide
diabetes
Amylin
Lilly
glimepiride

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Exenatide
Hypoglycemic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012