An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus - Tabular View

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An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

This study has been completed.

Study NCT00135330. Last updated on July 23, 2008. Information provided by Amylin Pharmaceuticals, Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

Official Title ^†

An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Brief Summary

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

To test the hypothesis that in patients with type 2 diabetes who have not achieved adequate glycemic control with metformin treatment, the addition of exenatide and rosiglitazone will provide superior beta-cell function [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Compare the effects of exenatide, rosiglitazone, and a combination of exenatide and rosiglitazone in subjects with type 2 diabetes treated with metformin on various pharmacodynamic measurements and safety and tolerability [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Compare total insulin secretion between the exenatide group, rosiglitazone group, and the exenatide plus rosiglitazone group [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

Drug: exenatide
Drug: rosiglitazone

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

140

Start Date ^†

October 2005

Completion Date

July 2008

Eligibility Criteria ^†

Inclusion Criteria:

HbA1c of 6.8% to 10.0%, inclusive.
Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

Exclusion Criteria:

Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors
Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.
Treated with any of the following medications:
- Thiazolidinedione within 5 months of screening;
- Sulfonylurea within 3 months of screening;
- Metformin/sulfonylurea combination therapy within 3 months of screening;
- Alpha-glucosidase inhibitor within 3 months of screening;
- Meglitinide within 3 months of screening;
- Insulin for more than 1 week within the 3 months prior to screening.
- Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
- Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
- Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
- Systemic antineoplastic agent
- Systemic transplantation medication
- Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00135330

Organization ID

H8O-US-GWAY

Secondary IDs ^††

Study Sponsor ^†

Amylin Pharmaceuticals, Inc.

Collaborators ^††

Eli Lilly and Company

Investigators ^†

Study Director:

James Malone, MD

Eli Lilly and Company

Information Provided By

Amylin Pharmaceuticals, Inc.

Verification Date

July 2008

First Received Date ^†

August 24, 2005

Last Updated Date

July 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.