Effects of Exenatide and Insulin Glargine in Subjects 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:	NCT00097500

Purpose

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide Drug: Insulin glargine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Open Label, Comparator Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Exenatide Insulin glargine

U.S. FDA Resources

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

Primary Outcome Measures:

To compare beta-cell function after intensified therapy with exenatide or insulin glargine in subjects with type 2 diabetes treated with metformin. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
To compare postprandial beta-cell function after long-term therapy with exenatide or insulin glargine in subjects with type 2 diabetes mellitus. [ Time Frame: 122 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the effects of intensified therapy with exenatide or insulin glargine in subjects with type 2 diabetes treated with metformin with respect to various pharmacodynamic measurements as well as safety and tolerability. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
To compare the effects following cessation of intensified therapy with exenatide or insulin glargine in subjects with type 2 diabetes treated with metformin on various pharmacodynamic measurements. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
To compare the effects following cessation of long-term intensified therapy with exenatide or insulin glargine in subjects with type 2 diabetes treated with metformin on various pharmacodynamic measurements. [ Time Frame: 122 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exenatide subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
2: Active Comparator	Drug: Insulin glargine subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HbA1c between 6.6% and 9.5%, inclusive.
Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
Treated with a stable dose of metformin for at least 3 months prior to screening.

Exclusion Criteria:

Patients previously in a study using exenatide.
Treated with oral anti-diabetic medications other than metformin within 3 months of screening.
Treated with insulin within 3 months of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097500

Locations

Finland
Research Site
Helsinki, Finland
Netherlands
Research Site
Amsterdam, Netherlands
Sweden
Research Site
Goteborg, Sweden

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director )
Study ID Numbers:	2993-114
Study First Received:	November 24, 2004
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00097500 History of Changes
Health Authority:	United States: Food and Drug Administration; Finland: Finnish Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Sweden: Medical Products Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
exendin-4
Amylin
Lilly

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010