An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
1 other identifier
interventional
137
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Oct 2005
Longer than P75 for phase_3 diabetes-mellitus-type-2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
August 28, 2009
CompletedApril 7, 2015
March 1, 2015
2.8 years
August 24, 2005
July 21, 2009
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ASIiAUC During a Hyperglycemic Clamp Test.
Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.
20 weeks
Secondary Outcomes (28)
Change in AUC for Glucose During a Meal Challenge Test (MCT).
Week 20
Change in Insulin Sensitivity Index as Measured by M-value.
Week 20
Change in Insulin AUC in the First Stage From Baseline to Endpoint.
Week 20
Change in Insulin iAUC From Baseline to Endpoint.
Week 20
Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
Week 20
- +23 more secondary outcomes
Study Arms (3)
Exenatide Arm
EXPERIMENTALExenatide plus Rosiglitazone Arm
EXPERIMENTALRosiglitazone Arm
EXPERIMENTALInterventions
subcutaneous injection, 5mcg or 10mcg, twice a day
oral tablet, 2mg or 4mg, twice a day
Eligibility Criteria
You may qualify if:
- HbA1c of 6.8% to 10.0%, inclusive.
- Body mass index (BMI) of 25 kg/m\^2 to 40 kg/m\^2, inclusive.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (19)
Research Site
Phoenix, Arizona, United States
Research Site
San Francisco, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Pittsfield, Massachusetts, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
Syracuse, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
League City, Texas, United States
Research Site
New Braunfels, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Renton, Washington, United States
Research Site
Spokane, Washington, United States
Related Publications (2)
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PMID: 22236356DERIVEDDeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC. Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin. Diabetes Care. 2010 May;33(5):951-7. doi: 10.2337/dc09-1521. Epub 2010 Jan 27.
PMID: 20107105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 26, 2005
Study Start
October 1, 2005
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 7, 2015
Results First Posted
August 28, 2009
Record last verified: 2015-03