Official Title: “A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control”

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes

Study Type: Interventional

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

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: pioglitazone hydrochloride (+) sitagliptin phosphate
  • Arm 1: sitagliptin 100mg tablets or Pbo + pioglitazone 15mg tablets or capsules or Pbo Arm 2: sitagliptin 100mg tablets + pioglitazone 30mg tablets or capsules or Pbo Arm 3: sitagliptin 100mg tablets + pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
• Drug: pioglitazone hydrochloride
  • Arm 4: pioglitazone 15mg tablets or capsules or Pbo. Arm 5: pioglitazone 30mg tablets or capsules or Pbo. Arm 6: pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
• Drug: sitagliptin phosphate
  • sitagliptin 100mg tablets or Pbo taken once daily for a treatment period of 54 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • sitagliptin/Pbo; pioglitazone/Pbo.
• Experimental: 2
  • sitagliptin/Pbo; pioglitazone/Pbo
• Experimental: 3
  • sitagliptin/Pbo; pioglitazone/Pbo
• Active Comparator: 4
  • pioglitazone/Pbo
• Active Comparator: 5
  • pioglitazone/Pbo
• Active Comparator: 6
  • pioglitazone/Pbo
• Experimental: 7
  • sitagliptin/Pbo

Primary Measures

• Test the safety and efficacy of the co-administration of sitagliptin and pioglitazone compared to sitagliptin monotherapy and pioglitazone monotherapy on HbA1c
  • Time Frame: Efficacy at 24 weeks, Safety at 54 weeks
    Safety Issue?: Yes

Secondary Measures

• HbA1c, 2-hour postprandial glucose, and fasting plasma glucose
  • Time Frame: 24 and 54 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient is is highly unlikely to conceive
• Patient is naïve to all AHA therapies
• Patient has T2DM and is =18 and = 78 years of age on day of signing informed consent

Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient has previously been treated with insulin, TZD (rosiglitazone or pioglitazone), any DPP-4 inhbitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
• Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
• Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
• Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 78 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00722371

Study ID Number: 2008_522

ClinicalTrials.gov Identifier: NCT00722371

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