Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
NCT ID: NCT00099320
Last Updated: 2015-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2004-05-31
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Exenatide
After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
exenatide
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.
Placebo
After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
Placebo
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.
Interventions
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exenatide
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c between 7.1% and 10.0%, inclusive.
* Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.
Exclusion Criteria
* 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.
21 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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James Malone, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
San Mateo, California, United States
Research Site
Santa Barbara, California, United States
Research Site
Spring Valley, California, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Butte, Montana, United States
Research Site
McCook, Nebraska, United States
Research Site
North Platte, Nebraska, United States
Research Site
Omaha, Nebraska, United States
Research Site
Scottsbluff, Nebraska, United States
Research Site
Princeton, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Albany, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Greenville, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Greenville, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Georgetown, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
The Colony, Texas, United States
Research Site
Olympia, Washington, United States
Research Site
Renton, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Charleston, West Virginia, United States
Research Site
Huntington, West Virginia, United States
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Dartmouth, Nova Scotia, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Granada, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Valladolid, , Spain
Research Site
Zaragoza, , Spain
Countries
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References
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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.
Zinman 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.
Other Identifiers
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H8O-MC-GWAP
Identifier Type: -
Identifier Source: org_study_id
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