Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Renal Disease, End-Stage
Intervention: sitagliptin phosphate (Drug); Comparator: glipizide (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in
patients with end-stage renal disease on dialysis.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks)
Secondary outcome: A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG data
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536
Merck Sharp & Dohme Co. Ltd., Petah Tikva 49192, Israel; Recruiting
Raanan Cohen, Phone: 972-3-9274005
Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-495-941-8264
Call for Information, Tempe, Arizona 85284, United States; Recruiting
Call for Information, Whittier, California 90603, United States; Recruiting
Call for Information, Sacramento, California 95825, United States; Recruiting
Call for Information, Mission Hills, California 91345, United States; Recruiting
Call for Information, Middleburg, Connecticut 06762, United States; Recruiting
Call for Information, Hudson, Florida 34667, United States; Recruiting
Call for Information, Macon, Georgia 31217, United States; Recruiting
Merck Sharp & Dohme (Asia) Ltd., Causeway Bay, Hong Kong Island, Hong Kong; Recruiting
Jane Lin, Phone: 862-1639-15522
Call for Information, Paterson, New Jersey 07503, United States; Recruiting
Call for Information, Yonkers, New York 10710, United States; Recruiting
Call for Information, Cincinnati, Ohio 45267-0585, United States; Recruiting
Call for Information, Orangeburg, South Carolina 29118, United States; Recruiting
Call for Information, Houston, Texas 77004-0000, United States; Recruiting
Additional Information
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
Starting date: October 2007
Ending date: April 2011
Last updated: October 16, 2009
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