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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results

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