Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
NCT ID: NCT00359879
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
377 participants
INTERVENTIONAL
2006-09-30
2007-07-31
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
NONE
Study Groups
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1 - exenatide before breakfast and dinner
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
2 - exenatide before lunch and dinner
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Interventions
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exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been treated with one of the following treatment regimens for at least three months prior to screening: \*metformin alone; \*sulfonylurea (SU) alone; \*thiazolidinedione (TZD) alone; \*a combination of metformin and SU; \*a combination of metformin and TZD.
* HbA1c between 7.1% and 10.0%, inclusive.
* Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2
Exclusion Criteria
* Have characteristics contraindicating metformin, SU, or TZD use.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
* Have used any prescription drug to promote weight loss within 3 months prior to screening.
* Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: \*insulin within 3 months prior to screening; \*alpha-glucosidase inhibitors within 3 months prior to screening; \*meglitinides within 3 months prior to screening; \*drugs that directly affect gastrointestinal motility
18 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
Campinas, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Fortaleza, , Brazil
Research Site
Goiânia, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Salvador, , Brazil
Research Site
São José do Rio Preto, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Aguascalientes, Aguascalientes, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
San Luis Potosí City, San Luis Potosí, Mexico
Research Site
Mérida, Yucatán, Mexico
Research Site
Mexico City, , Mexico
Countries
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References
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Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24.
Other Identifiers
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H8O-CR-GWBH
Identifier Type: -
Identifier Source: org_study_id
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