Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
1 other identifier
interventional
182
3 countries
51
Brief Summary
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.
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 May 2004
Shorter than P25 for phase_3 type-2-diabetes-mellitus
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFebruary 23, 2015
January 1, 2015
1.3 years
December 10, 2004
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
Baseline, Week 4, Week 8, Week 12, Week 16
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Baseline, Week 16
Secondary Outcomes (5)
Percentage of subjects reaching the target HbA1c (<7%)
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Change in body weight from Baseline to Week 16
Baseline, Week 16
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Baseline, Week 16
Changes in beta cell function and insulin sensitivity between Baseline and Week 16
Baseline, Week 16
Changes in lipids between Baseline and Week 16
Baseline, Week 16
Study Arms (2)
Exenatide
EXPERIMENTALAfter a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
Placebo
PLACEBO COMPARATORAfter a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
Interventions
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units \[5 μg\] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units \[10 μg\] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.
Eligibility Criteria
You may qualify if:
- Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
- HbA1c between 7.1% and 10.0%, inclusive.
- Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.
You may not qualify if:
- Patient previously in a study using exenatide or GLP-1 analogs.
- Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
- Treated with oral insulin within 3 months of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (51)
Research Site
Birmingham, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
San Mateo, California, United States
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Santa Barbara, California, United States
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Spring Valley, California, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Baton Rouge, Louisiana, United States
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Kalamazoo, Michigan, United States
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Troy, Michigan, United States
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Butte, Montana, United States
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McCook, Nebraska, United States
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North Platte, Nebraska, United States
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Omaha, Nebraska, United States
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Scottsbluff, Nebraska, United States
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Princeton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Greenville, North Carolina, United States
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Cleveland, Ohio, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Georgetown, Texas, United States
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San Antonio, Texas, United States
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The Colony, Texas, United States
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Olympia, Washington, United States
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Renton, Washington, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, United States
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Huntington, West Virginia, United States
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Dartmouth, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Granada, Spain
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Seville, Spain
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Valencia, Spain
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Valladolid, Spain
Research Site
Zaragoza, Spain
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: 22236356DERIVEDZinman B, Hoogwerf BJ, Duran Garcia S, Milton DR, Giaconia JM, Kim DD, Trautmann ME, Brodows RG. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Apr 3;146(7):477-85. doi: 10.7326/0003-4819-146-7-200704030-00003.
PMID: 17404349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
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
December 10, 2004
First Posted
December 13, 2004
Study Start
May 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
February 23, 2015
Record last verified: 2015-01