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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00791479 |
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on HbA1c at 12 weeks in patients with type 2 diabetes mellitus.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: LY2189265 and Lifestyle Measures Drug: Placebo solution and Lifestyle Measures |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions |
Estimated Enrollment: | 225 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
0.1 mg LY2189265 subcutaneous(SC) once weekly (QW)
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Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
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2: Experimental
0.5 mg LY2189265 SC QW
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Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
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3: Experimental
1.0 mg LY2189265 SC QW
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Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
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4: Experimental
3.0 mg LY2189265 SC QW
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Drug: LY2189265 and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
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5: Placebo Comparator
Placebo solution injected SC QW
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Drug: Placebo solution and Lifestyle Measures
Subcutaneous injection once-weekly for up to 12 weeks
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Patients in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-3 mg) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, hemoglobin A1c is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which patients will be randomized into 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via SC injections.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Study Chair: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( Chief Medical Officer ) |
Study ID Numbers: | 12565, H9X-MC-GBCK |
Study First Received: | November 12, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00791479 |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health; Poland: Ministry of Health; Croatia: Ministry of Health and Social Care; India: Ministry of Health; Denmark: Danish Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Ministry of Health |
Diabetes, type 2 diabetes |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |