A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin.

Condition(s) targeted: Type 2 Diabetes Mellitus, Non Insulin Dependent.; Diabetes Mellitus, Non-Insulin-Dependent

Intervention: Comparator: sitagliptin phosphate (Drug); Comparator: glimepiride (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

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: to assess the change from baseline in HbA1c glucose levels.

Secondary outcome: to assess the change from baseline fasting plasma glucose and number of hypoglycemic episodes.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 years or older

- Diagnosed with type 2 diabetes

- On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

- History of type 1 diabetes

- Pregnant; HIV positive

- On a weight loss program or medication

- Has a history of blood disorder, certain cancers, heart, liver or kidney disease

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

Merck Sharp & Dohme Gmbh, Vienna 1220, Austria; Recruiting
Andras Festa, Phone: 43-1-26044-130

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

Merck Sharp & Dohme (I.A.) Corp., San Jose, Costa Rica; Recruiting
Patricia Salazar, Phone: 506-2210-0116

Merck Sharp & Dohme, Glostrup 2600, Denmark; Recruiting
Christina Wengel, Phone: 45-43-28-77-90

Merck Sharp and Dohme (I.A.) Corp. Ecuador, Quito, Ecuador; Recruiting
Enrique Teran, Phone: 593-2-294-1714

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 (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 (New Zealand) Ltd.,, Auckland, New Zealand; Recruiting
David Woolner, Phone: 64-9523-6075

Merck Sharp & Dohme (I.A.) Corp., Panama Site Information, Panama; Recruiting
Patricia Salazar, Phone: 506-2210-0116

MSD Polska Sp. z o.o. Dzial Medyczny, Warszawa 00-867, Poland; Recruiting
Adam Czernik, Phone: 48 22 549-51-39

Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728

Merck Sharp & Dohme - Chibret, A.G., Glattbrugg 8152, Switzerland; Recruiting
Martin Fenner, Phone: 0041-1-828 7308

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

Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452396

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

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: May 2008
Ending date: November 2009
Last updated: January 15, 2009