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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00372060
First received: September 5, 2006
Last updated: February 21, 2014
Last verified: February 2014
  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:


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

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
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 ClinicalTrials.gov identifier: NCT00372060

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

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00372060     History of Changes
Other Study ID Numbers: 0431-055, 2006_029
Study First Received: September 5, 2006
Results First Received: January 27, 2009
Last Updated: February 21, 2014
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 July 24, 2014