Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
1 other identifier
interventional
165
5 countries
25
Brief Summary
This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate 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 type-2-diabetes-mellitus
Started Jan 2008
25 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
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
September 2, 2010
CompletedApril 7, 2015
March 1, 2015
1.5 years
January 17, 2008
July 20, 2010
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)
baseline and 26 weeks
Secondary Outcomes (10)
Percentage of Patients Achieving HbA1c <= 7%
26 weeks
Percentage of Patients Achieving HbA1c <= 6.5%
26 weeks
Change in Fasting Serum Glucose (FSG)
baseline and 26 weeks
Change in Body Weight
baseline and 26 weeks
Change in Waist Circumference
baseline and 26 weeks
- +5 more secondary outcomes
Study Arms (2)
Exenatide twice daily (BID)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes
- If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
- The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
- The metformin dose has been stable for at least 90 days
- Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
- Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2.
You may not qualify if:
- Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
- 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 screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
- Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
- Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
- Are currently treated with any of the following excluded medications:
- Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
- Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
- Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
- Pramlintide acetate injection within 3 months prior to screening
- Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (25)
Research Site
Birmingham, Alabama, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
Denver, Colorado, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Mogadore, Ohio, United States
Research Site
Corvallis, Oregon, United States
Research Site
New Westminster, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Chihuahua City, Chihuahua, Mexico
Research Site
Celaya, Guanajuato, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
Mexico City, Mexico
Research Site
Baia Mare, Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Dolj, Romania
Research Site
Iași, Romania
Research Site
Suceava, Romania
Research Site
Johannesburg, South Africa
Research Site
Pretoria, South Africa
Related Publications (2)
Liutkus J, Rosas Guzman J, Norwood P, Pop L, Northrup J, Cao D, Trautmann M. A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. Diabetes Obes Metab. 2010 Dec;12(12):1058-65. doi: 10.1111/j.1463-1326.2010.01251.x.
PMID: 20977576RESULTPencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
PMID: 22913891DERIVED
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
Chief Medical Officer, 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 29, 2008
Study Start
January 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
April 7, 2015
Results First Posted
September 2, 2010
Record last verified: 2015-03