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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00541450 |
A study to evaluate the efficacy and safety of Sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Comparator: sitagliptin phosphate Drug: Comparator: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: pioglitazone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 466 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase A: Experimental
Phase A: Drug
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Drug: Comparator: sitagliptin phosphate
sitagliptin 100mg tablet q.d. for a 4-wk treatment period.
Drug: Comparator: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/metformin HCL 50/1000mg bid. for a 34-wk treatment period
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Phase B: Active Comparator
Phase B: Active comparator
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Drug: Comparator: pioglitazone
pioglitazone 15mg tablet qd, titrating up to 45mg qd, for a 34-wk treatment period
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Ages Eligible for Study: | 18 Years to 78 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: | 2007_501, MK0431-068 |
Study First Received: | October 5, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00541450 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Pioglitazone Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |