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 Chronic Renal Insufficiency Who Have Inadequate Glycemic Control”

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in patients with moderate and severe renal insufficiency.

Study Type: Interventional

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

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Arm 1: drug + Pbo comparator
• Other: 2
  • Arm 2: drug + Pbo comparator
• Active Comparator: 3
  • Arm 3: Active comparator

Primary Measures

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

Secondary Measures

• Lower incidence of hypoglycemic events
  • Time Frame: Over 54 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient has type 2 diabetes mellitus
• Patient has moderate or severe renal insufficiency

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 is on dialysis or is likely to need dialysis during the study

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 August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509262

Study ID Number: 2007_549

ClinicalTrials.gov Identifier: NCT00509262

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