MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: pioglitazone hydrochloride (+) sitagliptin phosphate (Drug); pioglitazone hydrochloride (Drug); sitagliptin phosphate (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 evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes

Official title: A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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

Primary outcome: Test the safety and efficacy of the co-administration of sitagliptin and pioglitazone compared to sitagliptin monotherapy and pioglitazone monotherapy on HbA1c

Secondary outcome: HbA1c, 2-hour postprandial glucose, and fasting plasma glucose

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is is highly unlikely to conceive

- Patient is naïve to all AHA therapies

- Patient has T2DM and is =18 and = 78 years of age on day of signing informed consent

Exclusion Criteria:

- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

- Patient has previously been treated with insulin, TZD (rosiglitazone or

pioglitazone), any DPP-4 inhbitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic

- Patient is on a weight loss program and is not in the maintenance phase or has

started a weight loss medication (e. g. orlistat or sibutramine) within the prior 8 weeks

- Patient has undergone surgery within the prior 30 days or has major surgery planned

during the study

- Patient has a medical history of active liver disease including chronic active

hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis

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

Merck Sharp & Dohme (Australia) Pty Ltd., South Granville NSW 2142, Australia; Recruiting
David Woolner, Phone: 64-9-523-6075

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 IDEA, Inc., Zagreb 10 010, Croatia; Recruiting
Goranka Glad Scherr, Phone: 385 1 66 44 336

Merck Sharp & Dohme Scientific Office, Cairo, Egypt; Recruiting
Sherif Canaan, Phone: 202-2417-2320

Vianex, S.A. / MSD, Nea Erythrea 146 71, Greece; Recruiting
Fotini Vlasserou, Phone: 30-210-8009435

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

Merck Sharp & Dohme Idea Inc, Riga 1013, Latvia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243

Merck Sharpe & Dohme Idea Inc., Lebanon Site Information, Lebanon; Recruiting
Amal Chalfoun, Phone: 961-4-542590

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 , Saudi Arabia, Riyadh, Saudi Arabia; Recruiting
Maged Kamel, Phone: 966-1-405-6320

Merck Sharp & Dohme, Novi Beograd, Serbia; Recruiting
Aneta Sokolova, Phone: 359 2 963 1076

Merck Sharp & Dohme Idea, Inc, Ljubljana, Slovenia; Recruiting
Karmen Letonja, Phone: 386 1 5204 214

Merck Sharp & Dohme (I.A.) Corp., Taipei [106, Taiwan; Recruiting
Avery Basil Ince, Phone: 886 2 23761610

Call for Information, Tucson, Arizona 85745, United States; Recruiting

Call for Information, Tempe, Arizona 85282, United States; Recruiting

Call for Information, Chandler, Arizona 85224, United States; Recruiting

Call for Information, Torrance, California 90505, United States; Recruiting

Call for Information, Spring Valley, California 91978-0000, United States; Recruiting

Call for Information, Simi Valley, California 93065, United States; Recruiting

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

Call for Information, Paramount, California 90723, United States; Recruiting

Call for Information, Palm Desert, California 92260, United States; Recruiting

Call for Information, Fresno, California 93721-0000, United States; Recruiting

Call for Information, Alhambra, California 91801, United States; Recruiting

Call for Information, Colorado Springs, Colorado 80909, United States; Recruiting

Call for Information, Colorado Springs, Colorado 80907, United States; Recruiting

Call for Information, Arvada, Colorado 80005, United States; Recruiting

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 IDEA, Inc., Tallinn, Eesti 11415, Estonia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243

Call for Information, Pembroke Pines, Florida 33028, United States; Recruiting

Call for Information, Miami, Florida 33135, United States; Recruiting

Call for Information, Hialeah, Florida 33012, United States; Recruiting

Call for Information, Altamonte Springs, Florida 32701, United States; Recruiting

MSD (Pty) LTD South Africa, Midrand, Gauteng 1685, South Africa; Recruiting
Beverley Cowper, Phone: 27 11 655-3036

Call for Information, Roswell, Georgia 30076, United States; Recruiting

Call for Information, Dunwoody, Georgia 30338, United States; Recruiting

Call for Information, Conyers, Georgia 30094, United States; Recruiting

Call for Information, Augusta, Georgia 30904, United States; Recruiting

Call for Information, Atlanta, Georgia 30308, United States; Recruiting

Call for Information, Peoria, Illinois 61515, United States; Recruiting

Call for Information, Gillespie, Illinois 62033, United States; Recruiting

Call for Information, Chicago, Illinois 60607-0000, United States; Recruiting

Call for Information, Indianapolis, Indiana 46254, United States; Recruiting

Call for Information, Avon, Indiana 46123, United States; Recruiting

Call for Information, Des Moines, Iowa 50314, United States; Recruiting

Merck Sharp & Dohme Ilaclari Ltd. Sti, Istinye, Istanbul 34460, Turkey; Recruiting
Meltem Telaferli, Phone: 90 212 365 5354

Call for Information, Overland Park, Kansas 66215, United States; Recruiting

Call for Information, Arkansas City, Kansas 67005, United States; Recruiting

Call for Information, Lexington, Kentucky 40504, United States; Recruiting

Call for Information, Bardstown, Kentucky 40004, United States; Recruiting

UAB Merck Sharp & Dohme, Vilnius, Lietuva, Lithuania; Recruiting
Andrius Bacevicius, Phone: 3705 2 780 243

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

Call for Information, Elkton, Maryland 21921-0000, United States; Recruiting

Call for Information, Brockton, Massachusetts 02301, United States; Recruiting

Call for Information, Wildwood Crest, New Jersey 08260, United States; Recruiting

Call for Information, Trenton, New Jersey 08611, United States; Recruiting

Call for Information, Toms River, New Jersey 08753, United States; Recruiting

Call for Information, Brick, New Jersey 08724, United States; Recruiting

Call for Information, Brick, New Jersey 08723, United States; Recruiting

Call for Information, Statesville, North Carolina 28625, United States; Recruiting

Call for Information, Raleigh, North Carolina 27609-0000, United States; Recruiting

Call for Information, Mooresville, North Carolina 28117, United States; Recruiting

Call for Information, High Point, North Carolina 27262, United States; Recruiting

Call for Information, Greensboro, North Carolina 27408, United States; Recruiting

Call for Information, Charlotte, North Carolina 28209, United States; Recruiting

Call for Information, Burlington, North Carolina 27215, United States; Recruiting

Call for Information, Stow, Ohio 44224, United States; Recruiting

Call for Information, London, Ohio 43140, United States; Recruiting

Call for Information, Delaware, Ohio 43015, United States; Recruiting

Call for Information, Columbus, Ohio 43213, United States; Recruiting

Call for Information, Columbus, Ohio 43201, United States; Recruiting

Call for Information, Canal Fulton, Ohio 44614, United States; Recruiting

Call for Information, Akron, Ohio 44320, United States; Recruiting

Call for Information, Yukon, Oklahoma 73099, United States; Recruiting

Call for Information, Pryor, Oklahoma 74361, United States; Recruiting

Call for Information, Corvallis, Oregon 97330, United States; Recruiting

Call for Information, Uniontown, Pennsylvania 15401, United States; Recruiting

Call for Information, Tipton, Pennsylvania 16684, United States; Recruiting

Call for Information, Pottstown, Pennsylvania 19464, United States; Recruiting

Call for Information, Lansdale, Pennsylvania 19446, United States; Recruiting

Call for Information, Carnegie, Pennsylvania 15106, United States; Recruiting

Call for Information, Beaver, Pennsylvania 15009, United States; Recruiting

Call for Information, East Providence, Rhode Island 02914, United States; Recruiting

Call for Information, Simpsonville, South Carolina 29681, 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, Plano, Texas 75024, United States; Recruiting

Call for Information, Pearland, Texas 77584, United States; Recruiting

Call for Information, Houston, Texas 77081, United States; Recruiting

Call for Information, Houston, Texas 77036, United States; Recruiting

Call for Information, Houston, Texas 77024-0000, United States; Recruiting

Call for Information, Grand Prairie, Texas 75052, United States; Recruiting

Call for Information, Georgetown, Texas 78626, United States; Recruiting

Call for Information, Dallas, Texas 75235, United States; Recruiting

Call for Information, Arlington, Texas 76014, United States; Recruiting

Call for Information, Magna, Utah 84044, United States; Recruiting

Call for Information, Virginia Beach, Virginia 23455, United States; Recruiting

Call for Information, Menomonee Falls, Wisconsin 53051, 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: January 2008
Ending date: May 2011
Last updated: October 16, 2009