A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT01001104 |
Recruitment Status :
Completed
First Posted : October 23, 2009
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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Tracking Information | ||||
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First Submitted Date ICMJE | October 22, 2009 | |||
First Posted Date ICMJE | October 23, 2009 | |||
Results First Submitted Date ICMJE | October 3, 2014 | |||
Results First Posted Date ICMJE | September 28, 2015 | |||
Last Update Posted Date | September 28, 2015 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks [ Time Frame: Baseline, 12 weeks ] Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
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Original Primary Outcome Measures ICMJE |
Change in glycosylated hemoglobin (HbA1c) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of LY2189265 in Japanese Patients With Type 2 Diabetes | |||
Official Title ICMJE | Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes | |||
Brief Summary | The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
145 | |||
Original Estimated Enrollment ICMJE |
144 | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01001104 | |||
Other Study ID Numbers ICMJE | 12840 H9X-JE-GBCZ ( Other Identifier: Eli Lilly and Company ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Eli Lilly and Company | |||
Study Sponsor ICMJE | Eli Lilly and Company | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Eli Lilly and Company | |||
Verification Date | August 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |