A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
NCT ID: NCT00382239
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
PHASE2
153 participants
INTERVENTIONAL
2006-09-30
2007-05-31
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 5 mcg/exenatide 10 mcg
exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
Exenatide 5 mcg/exenatide 5 mcg
exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
Exenatide 2.5 mcg/exenatide 2.5 mcg
exenatide (LY2148568)
subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
Placebo/placebo
Placebo
subcutaneous injection twice daily, 0.02 mL to 0.04 mL
Interventions
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exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
exenatide (LY2148568)
subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
Placebo
subcutaneous injection twice daily, 0.02 mL to 0.04 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body weight of \>=50 kg.
Exclusion Criteria
* Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
* Are treated with any exogenous insulin within 3 months of screening.
* Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): \*drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
* Have characteristics contraindicating for concomitant medication, according to product-specific label.
* Have severe allergy or hypersensitivity to any drug.
20 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
Fukuoka, , Japan
Research Site
Fukushima, , Japan
Research Site
Gunma, , Japan
Research Site
Hiroshima, , Japan
Research Site
Hyōgo, , Japan
Research Site
Ibaraki, , Japan
Research Site
Kanagawa, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kyoto, , Japan
Research Site
Nagano, , Japan
Research Site
Okayama, , Japan
Research Site
Osaka, , Japan
Research Site
Ōita, , Japan
Research Site
Tokyo, , Japan
Countries
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References
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Kadowaki T, Namba M, Yamamura A, Sowa H, Wolka AM, Brodows RG. Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes. Endocr J. 2009;56(3):415-24. doi: 10.1507/endocrj.k08e-296. Epub 2009 Feb 4.
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-JE-GWAV
Identifier Type: -
Identifier Source: org_study_id
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