Official Title: “A Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control”

The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in patients with end-stage renal disease on dialysis.

Study Type: Interventional

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

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: sitagliptin phosphate
  • sitagliptin phosphate 25mg tablet, for a 54-wk treatment period.
• Drug: Comparator: glipizide
  • glipizide 2.5mg qd, titrating up to 10mg bid, based on glycemic control for a 54-wk treatment period.
• Drug: Comparator: Placebo (unspecified)
  • Glipizide 2.5mg Pbo qd, for a 54-wk treatment period.
• Drug: Comparator: Placebo (unspecified)
  • sitagliptin 25mg Pbo tablet, for a 54-wk treatment period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: drug
• Active Comparator: 2
  • Arm 2: Active comparator

Primary Measures

• HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks)
  • Time Frame: 54 weeks
    Safety Issue?: No

Secondary Measures

• A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG data
  • Time Frame: At the end of 54 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient is on dialysis.

Exclusion Criteria:

• Patient has type 1 diabetes mellitus or a history of ketoacidosis
• Patient is on a new weight loss program
• Patient has active liver disease
• Patient has been on dialysis for less than 6 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 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 September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509236

Study ID Number: 2007_550

ClinicalTrials.gov Identifier: NCT00509236

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