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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00722371 |
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: pioglitazone hydrochloride (+) sitagliptin phosphate Drug: pioglitazone hydrochloride Drug: sitagliptin phosphate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
Estimated Enrollment: | 1295 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
sitagliptin/Pbo; pioglitazone/Pbo.
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Drug: pioglitazone hydrochloride (+) sitagliptin phosphate
Arm 1: sitagliptin 100mg tablets or Pbo + pioglitazone 15mg tablets or capsules or Pbo Arm 2: sitagliptin 100mg tablets + pioglitazone 30mg tablets or capsules or Pbo Arm 3: sitagliptin 100mg tablets + pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
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2: Experimental
sitagliptin/Pbo; pioglitazone/Pbo
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Drug: pioglitazone hydrochloride (+) sitagliptin phosphate
Arm 1: sitagliptin 100mg tablets or Pbo + pioglitazone 15mg tablets or capsules or Pbo Arm 2: sitagliptin 100mg tablets + pioglitazone 30mg tablets or capsules or Pbo Arm 3: sitagliptin 100mg tablets + pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
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3: Experimental
sitagliptin/Pbo; pioglitazone/Pbo
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Drug: pioglitazone hydrochloride (+) sitagliptin phosphate
Arm 1: sitagliptin 100mg tablets or Pbo + pioglitazone 15mg tablets or capsules or Pbo Arm 2: sitagliptin 100mg tablets + pioglitazone 30mg tablets or capsules or Pbo Arm 3: sitagliptin 100mg tablets + pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
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4: Active Comparator
pioglitazone/Pbo
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Drug: pioglitazone hydrochloride
Arm 4: pioglitazone 15mg tablets or capsules or Pbo. Arm 5: pioglitazone 30mg tablets or capsules or Pbo. Arm 6: pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
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5: Active Comparator
pioglitazone/Pbo
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Drug: pioglitazone hydrochloride
Arm 4: pioglitazone 15mg tablets or capsules or Pbo. Arm 5: pioglitazone 30mg tablets or capsules or Pbo. Arm 6: pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
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6: Active Comparator
pioglitazone/Pbo
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Drug: pioglitazone hydrochloride
Arm 4: pioglitazone 15mg tablets or capsules or Pbo. Arm 5: pioglitazone 30mg tablets or capsules or Pbo. Arm 6: pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
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7: Experimental
sitagliptin/Pbo
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Drug: sitagliptin phosphate
sitagliptin 100mg tablets or Pbo taken once daily for a treatment period of 54 weeks.
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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: | 2008_522, MK0431-102 |
Study First Received: | July 22, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00722371 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Pioglitazone Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors |
Pharmacologic Actions Sitagliptin Protease Inhibitors Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |