Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
NCT ID: NCT00324363
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
466 participants
INTERVENTIONAL
2006-01-31
2007-04-30
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
Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
Placebo
Placebo in volume equal to exenatide
Placebo
subcutaneous injection twice daily in volumes equal to exenatide
Interventions
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exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks
Placebo
subcutaneous injection twice daily in volumes equal to exenatide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c between 7.1% and 11.0%, inclusive.
* Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2.
Exclusion Criteria
* Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
* Have characteristics contraindicating metformin or sulfonylurea use.
* Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
* Have used drugs for weight loss within 1 month 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
Beijing, , China
Research Site
Guangzhou, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Sichuan, , China
Research Site
Chennai, , India
Research Site
Mumbai, , India
Research Site
Pune, , India
Research Site
Seoul, , South Korea
Research Site
Sungnam City, , South Korea
Research Site
Chiayi City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
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.
Gao Y, Yoon KH, Chuang LM, Mohan V, Ning G, Shah S, Jang HC, Wu TJ, Johns D, Northrup J, Brodows R. Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea. Diabetes Res Clin Pract. 2009 Jan;83(1):69-76. doi: 10.1016/j.diabres.2008.09.037. Epub 2008 Nov 18.
Other Identifiers
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H8O-MC-GWBA
Identifier Type: -
Identifier Source: org_study_id
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