Official Title: “A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus”

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Study Type: Interventional

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

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: sitagliptin phosphate
  • sitagliptin 50mg tablets qd. For 24 Weeks of treatment.
• Drug: Comparator : pioglitazone hydrochloride
  • pioglitazone 30mg tablet qd. For 24 Weeks of Treatment.
• Drug: Comparator : Placebo (unspecified)
  • sitagliptin 50mg Pbo tablets. for 24 Weeks of treatment.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • sitagliptin 50mg Pbo tablets/pioglitazone 30mg tablet qd
• Other: 2
  • sitagliptin 50mg tablets/pioglitazone 30mg tablet qd

Primary Measures

• HbA1c
  • Time Frame: After 24 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 24 weeks
    Safety Issue?: Yes

Secondary Measures

• 2-hr PPG
  • Time Frame: After 2 Hours
    Safety Issue?: No
• FPG
  • Time Frame: After 24 weeks
    Safety Issue?: No
• FPG
  • Time Frame: After 1 week
    Safety Issue?: No
• HOMA-b, insulinogenic index, proinsulin to insulin ratio, and glucose AUC/insulin AUC
  • Time Frame: After 24 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

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 4 months
• Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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 November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00397631

Study ID Number: 2006_531

ClinicalTrials.gov Identifier: NCT00397631

Health Authority: United States: Food and Drug Administration

(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)