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 III

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

MedlinePlus related topics: Diabetes

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:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

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:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-EW-GWBE
Study First Received:	July 31, 2006
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00359762 History of Changes
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:

Metabolic Diseases
Exenatide
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010