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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 19, 2007
Last updated: December 16, 2015
Last verified: December 2015
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Drug: Comparator: pioglitazone
pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
Other Name: pioglitazone


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00532935

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00532935     History of Changes
Other Study ID Numbers: 0431A-066  2007_510 
Study First Received: September 19, 2007
Results First Received: September 23, 2010
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 23, 2016