Status:
COMPLETED
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- HbA1c of 6.8% to 10.0%, inclusive.
- Body mass index (BMI) of 25 kg/m\^2 to 40 kg/m\^2, inclusive.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00135330
Start Date
October 1 2005
End Date
July 1 2008
Last Update
April 7 2015
Active Locations (19)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
San Francisco, California, United States
3
Research Site
Jacksonville, Florida, United States
4
Research Site
Orlando, Florida, United States