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 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 (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 (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, Reseda, California 91335, United States; Recruiting

Call for Information, Mission Hills, California 91345, United States; Recruiting

Call for Information, Long Beach, California 90822, 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, Hialeah, Florida 33012, 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, Detroit, Michigan 48201-0000, United States; Recruiting

Call for Information, Las Vegas, Nevada 89101, 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, San Antonio, Texas 78229, United States; Recruiting

Call for Information, San Antonio, Texas 78224, United States; Recruiting

Call for Information, Dallas, Texas 75246, United States; Recruiting

Call for Information, Salem, Virginia 24153, United States; Recruiting

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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 14, 2009