Initial Combination With Pioglitazone Study

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.

Intervention(s) in this Clinical Trial

• Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d
  • Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.
• Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
  • Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
• Active Comparator: 2
  • sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d.

Primary Measures

• Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
  • Time Frame: Baseline and 24 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
  • Time Frame: Baseline and Week 24
    Safety Issue?: No
• Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24
  • Time Frame: Baseline and Week 24
    Safety Issue?: No

General Inclusion Criteria:

• Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General 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 Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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