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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00767000 |
The purpose of this study is to test the effect of MK0941 as add-on therapy for patients taking insulin for Type 2 Diabetes.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Comparator: MK0941 Drug: Comparator: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin |
Estimated Enrollment: | 550 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MK0941
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Drug: Comparator: MK0941
Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
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2: Experimental
MK0941
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Drug: Comparator: MK0941
Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
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3: Experimental
MK0941
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Drug: Comparator: MK0941
Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
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4: Experimental
MK0941
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Drug: Comparator: MK0941
Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
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5: Placebo Comparator
Placebo
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Drug: Comparator: Placebo
Placebo to MK0941
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Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_557, MK0941-007 |
Study First Received: | October 3, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00767000 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |