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
233 participants
INTERVENTIONAL
2006-09-30
2007-09-30
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 5 mcg/exenatide 5 mcg
Exenatide 5 mcg; then exenatide 5 mcg
exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
Exenatide 5 mcg/exenatide 10 mcg
Exenatide 5 mcg, then exenatide 10 mcg
exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
Placebo
Placebo in volumes equivalent to exenatide
placebo
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
Interventions
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exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
placebo
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treating diabetes with diet and exercise
* HbA1c between 6.5% and 10.0%, inclusive
* Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive
Exclusion Criteria
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have been treated with any antidiabetic agent
* Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
* Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
18 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
Idaho Falls, Idaho, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Aligarh, , India
Research Site
Bangalore, , India
Research Site
Chennai, , India
Research Site
Indore, , India
Research Site
Karnāl, , India
Research Site
New Delhi, , India
Research Site
Vellore, , India
Research Site
Manatí, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
Alba Iulia, , Romania
Research Site
Baia Mare, , Romania
Research Site
Bucharest, , Romania
Research Site
Galati, , Romania
Research Site
Oradea, , Romania
Research Site
Târgu Mureş, , Romania
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Countries
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References
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Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2008 Aug;30(8):1448-60. doi: 10.1016/j.clinthera.2008.08.006.
Pencek 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.
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.
Other Identifiers
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H8O-MC-GWBJ
Identifier Type: -
Identifier Source: org_study_id
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