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

Verified by: Merck, April 2010
First Received: September 5, 2006 | Last Updated: April 20, 2010 | Phase: Phase 3 | Start Date: August 2006
Overall Status: Completed | Estimated Enrollment: 134
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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...

Brief Summary

Official Title: “MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for Patients With Type 2 Diabetes Mellitus”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

  • Drug: sitagliptin phosphate
    • Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
  • Drug: Comparator: sitagliptin phosphate (MK0431)
    • Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
  • Drug: Comparator: pioglitazone
    • pioglitazone once daily for 52 weeks
  • Drug: Comparator: placebo (unspecified)
    • Placebo once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • MK0431 + pioglitazone
  • Placebo Comparator: 2
    • Placebo/MK0431 + pioglitazone

Outcome Measures for this Clinical Trial

Primary Measures

  • Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12
    • Time Frame: 12 Weeks
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Fasting Plasma Glucose at Week 12
    • Time Frame: 12 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients Have Type 1 Diabetes Mellitus

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00372060

Study ID Number: 2006_029

ClinicalTrials.gov Identifier: NCT00372060

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00372060