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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00479466 |
A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: MK0893 Drug: Comparator: metformin Drug: Comparator: placebo (unspecified) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
Estimated Enrollment: | 705 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm 1: MK0893 80 mg tablet once daily.
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Drug: MK0893
MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
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2: Experimental
Arm 2: MK0893 60 mg tablet once daily.
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Drug: MK0893
MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
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3: Experimental
Arm 3: MK0893 40 mg tablet once daily..
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Drug: MK0893
MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
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4: Experimental
Arm 4: MK0893 20 mg tablet once daily.
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Drug: MK0893
MK0893 80 mg tablet; 60 mg tablet; 40 mg tablet; 20 mg tablet, once daily.
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5: Active Comparator
Arm 5: Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
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Drug: Comparator: metformin
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
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6: Placebo Comparator
Arm 6: Pbo tablets. 12 week treatment period.
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Drug: Comparator: placebo (unspecified)
MK0893 80 mg Pbo tablet; 60 mg Pbo tablet; 40 mg Pbo tablet; 20 mg Pbo tablet, once daily.
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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 |
Germany | |
Msd Sharp & Dohme Gmbh | Recruiting |
Haar, Germany, 85540 | |
Contact: Thomas Lang 49-89-4561-1536 | |
Mexico, D.F. | |
Merck Sharp & Dohme De Mexico, S.A. De C.V. | Recruiting |
Mexico, D.F., Mexico, 1090 | |
Contact: Juan Diaz 52-55-5481-9825 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_526, MK0893-008 |
Study First Received: | May 25, 2007 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00479466 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |