Official Title: “Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency”

The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Study Type: Interventional

Study Design: Treatment, Randomized

Intervention(s) in this Clinical Trial

• Drug: MK0431, sitagliptin phosphate/Duration of Treatment - 54 wks
• Drug: Comparator: glipizide / Duration of Treatment - 42 wks

Primary Measures

• Safety and tolerability of sitagliptin after 12 weeks of treatment

Secondary Measures

• Safety and tolerability of sitagliptin over 54 weeks

Inclusion Criteria:

• Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
• Patient has renal (kidney) insufficiency (inadequate kidney function)

Exclusion Criteria:

• Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
• Pregnant or breast feeding

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  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095056

Study ID Number: 2004_054

ClinicalTrials.gov Identifier: NCT00095056

Health Authority: United States: Food and Drug Administration