An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; Chronic Renal Insufficiency
Intervention: MK0431, sitagliptin phosphate/Duration of Treatment - 54 wks (Drug); Comparator: glipizide / Duration of Treatment - 42 wks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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).
Clinical Details
Official title: Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Study design: Treatment, Randomized
Primary outcome: Safety and tolerability of sitagliptin after 12 weeks of treatment
Secondary outcome: Safety and tolerability of sitagliptin over 54 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: December 2004
Ending date: July 2006
Last updated: January 2, 2008
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