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MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00372060
First received: September 5, 2006
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: sitagliptin phosphate
Drug: Comparator: sitagliptin phosphate (MK0431)
Drug: Comparator: pioglitazone
Drug: Comparator: placebo (unspecified)
 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: MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for 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 Hemoglobin A1c (HbA1c ) at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.


Other Outcome Measures:
  • Change From Baseline in 2 Hour Postprandial Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.

  • Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52 [ Time Frame: Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group. ] [ Designated as safety issue: No ]
    Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.


Enrollment: 134
Study Start Date: August 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0431 + pioglitazone
 Drug: sitagliptin phosphate
Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
Other Name: MK0431
Drug: Comparator: pioglitazone
pioglitazone once daily for 52 weeks
Placebo Comparator: 2
Placebo/MK0431 + pioglitazone
 Drug: Comparator: sitagliptin phosphate (MK0431)
Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
Other Name: MK0431
Drug: Comparator: pioglitazone
pioglitazone once daily for 52 weeks
Drug: Comparator: placebo (unspecified)
Placebo once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients Have Type 2 Diabetes Mellitus
  • On Diet/Exercise Therapy And Pioglitazone As Monotherapy

Exclusion Criteria:

  • Patients Have Type 1 Diabetes Mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372060

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

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00372060     History of Changes
Other Study ID Numbers: 2006_029, MK0431-055
Study First Received: September 5, 2006
Results First Received: January 27, 2009
Last Updated: March 21, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Sitagliptin
 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 June 18, 2013