Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Condition(s) targeted: Type 2 Diabetes Mellitus; Renal Insufficiency, Chronic

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

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

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

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 clinic visits every 6 weeks).

Secondary outcome: Lower incidence of hypoglycemic events

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Toll Free Number, Phone: 1-888-577-8839

Merck Sharp & Dohme (I.A.) Corp., Santiago 6761641, Chile; Recruiting
Jorge Vinces, Phone: 51-1-411-5933

Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Jean-Marie Goehrs, Phone: 33-1-4754-89-90

Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536

MSD Guatemala, Guatemala 1010, Guatemala; Recruiting
Patricia Salazar, Phone: 506-2210-0116

MSD Pharmaceuticals Private Ltd., New Delhi 110011, India; Recruiting
Swashraya Shah, Phone: 91-124-464-7338

Merck Sharp & Dohme Co. Ltd., Petah Tikva 49192, Israel; Recruiting
Raanan Cohen, Phone: 972-3-9274005

Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187

MSD Korea Ltd., Seoul 121-705, Korea, Republic of; Recruiting
Steve Kim, Phone: 82-2-6363-0241

Merck Sharp & Dohme (I.A.) Corp, Selangor 46300, Malaysia; Recruiting
Nazrin Azli, Phone: 603-77181748

Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700

Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-495-941-8264

Merck Sharp & Dohme (Singapore), Singapore 199555, Singapore; Recruiting
Nazrin Azli, Phone: 603-77181748

Merck Sharp & Dohme (Sweden) AB, Sollentuna 192 07, Sweden; Recruiting
Roger Juhlin, Phone: 46-8-626-1 458

MSD (Thailand) Ltd., Bangkok 10330, Thailand; Recruiting
Suchai Kitsiripornchai, Phone: 66-2-255-5090

Call for Information, West Hills, California 91307, United States; Recruiting

Call for Information, Roseville, California 95661, United States; Recruiting

Call for Information, Riverside, California 92505, United States; Recruiting

Call for Information, Reseda, California 91335, United States; Recruiting

Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400

Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825

Call for Information, West Palm Beach, Florida 33401-0000, United States; Recruiting

Merck Sharp & Dohme (Asia) Ltd., Causeway Bay, Hong Kong Island, Hong Kong; Recruiting
Jane Lin, Phone: 862-1639-15522

Merck Sharp & Dohme, Peru S.R.L., Surquillo, Lima LIMA 34, Peru; Recruiting
Jorge Vinces, Phone: 511-411-5933

Call for Information, Detroit, Michigan 48201, United States; Recruiting

Call for Information, Bay City, Michigan 48706, United States; Recruiting

Call for Information, Rochester, New York 14607, United States; Recruiting

Call for Information, New York, New York 10128, United States; Recruiting

Call for Information, Rocky Mount, North Carolina 27804, United States; Recruiting

Call for Information, Raleigh, North Carolina 27609, United States; Recruiting

Call for Information, Kinston, North Carolina 28504, United States; Recruiting

Call for Information, Greenville, North Carolina 27834, United States; Recruiting

Call for Information, Allentown, Pennsylvania 18103, United States; Recruiting

Call for Information, San Antonio, Texas 78229, United States; Recruiting

Call for Information, Lufkin, Texas 75904, United States; Recruiting

Call for Information, Federal Way, Washington 98003, United States; Recruiting

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: August 2007
Last updated: October 29, 2008