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MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00532935
First received: September 19, 2007
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  Purpose

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: sitagliptin phosphate (+) metformin hydrochloride
Drug: Comparator: pioglitazone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in A1C at Week 32 [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
    A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone

  • Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG

  • Change From Baseline in FPG at Week 32 [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 32 FPG minus the baseline FPG

  • Percent of Participants With A1C <7.0% at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]

Enrollment: 517
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sitagliptin phosphate (+) metformin hydrochloride
 Drug: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
Other Name: Janumet
Active Comparator: 2
pioglitazone
 Drug: Comparator: pioglitazone
pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
Other Name: pioglitazone

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
  • Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532935

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00532935     History of Changes
Other Study ID Numbers: MK-0431A-066, 2007_510
Study First Received: September 19, 2007
Results First Received: September 23, 2010
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Sitagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013