Official Title: “A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin”

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Study Type: Interventional

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

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: sitagliptin phosphate
  • 100 mg sitagliptin per day; Duration of Treatment: 34 Weeks
• Drug: glimepiride
  • glimepiride 1 mg per day to be up-titrated as considered appropriate by the investigator, based upon the results of patient's self-blood glucose monitoring (SBGM) over the initial 18 weeks of the double-blind treatment period. The maximum dose of glimepiride must not be higher than 6 mg/day.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • sitagliptin
• Active Comparator: 2
  • glimepiride

Primary Measures

• to assess the change from baseline in HbA1c glucose levels.
  • Time Frame: 30 weeks
    Safety Issue?: No

Secondary Measures

• to assess the change from baseline fasting plasma glucose and number of hypoglycemic episodes.
  • Time Frame: 30 weeks
    Safety Issue?: No

Inclusion Criteria:

• 18 years or older
• Diagnosed with type 2 diabetes
• On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

• History of type 1 diabetes
• Pregnant; HIV positive
• On a weight loss program or medication
• Has a history of blood disorder, certain cancers, heart, liver or kidney disease

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  

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

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701090

Study ID Number: 2008_503

ClinicalTrials.gov Identifier: NCT00701090

Health Authority: Austria: Federal Ministry for Health and Women

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