A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes
NCT ID: NCT00612794
Last Updated: 2015-02-24
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
PHASE1
30 participants
INTERVENTIONAL
2007-09-30
2008-05-31
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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1
exenatide once weekly, 0.8mg
exenatide once weekly
subcutaneous injection, once weekly
2
exenatide once weekly, 2.0mg
exenatide once weekly
subcutaneous injection, once weekly
3
volume equivalent to 0.8mg of exenatide once weekly
placebo
subcutaneous injection, once weekly
4
volume equivalent to 2.0mg of exenatide once weekly
placebo
subcutaneous injection, once weekly
Interventions
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exenatide once weekly
subcutaneous injection, once weekly
placebo
subcutaneous injection, once weekly
Eligibility Criteria
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Inclusion Criteria
* Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: \*6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; \*6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.
* Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® \[acarbose\], Basen® \[voglibose\], or Seibule® \[miglitol\]) or meglitinide derivatives (Glufast® \[mitiglinide\] or Fastic®/Starsis® \[nateglinide\]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.
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 participated and received at least one dose of exenatide or other GLP-1 analogs 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).
* Females who are breastfeeding.
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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Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Research Site
Fukuoka, , Japan
Research Site
Kanagawa, , Japan
Research Site
Osaka, , Japan
Research Site
Tokyo, , Japan
Countries
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References
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Iwamoto K, Nasu R, Yamamura A, Kothare PA, Mace K, Wolka AM, Linnebjerg H. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J. 2009;56(8):951-62. doi: 10.1507/endocrj.k09e-147. Epub 2009 Aug 25.
Other Identifiers
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H8O-JE-GWBW
Identifier Type: -
Identifier Source: org_study_id
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