Sitagliptin (MK0431) Versus Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Sitagliptin (Drug); Comparator: placebo (Drug); pioglitazone (Drug); metformin (Drug); glipizide (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

This study will examine the safety and efficacy of the addition of sitagliptin (MK0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.

Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and Pioglitazone

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Level of A1C

Secondary outcome: Post meal glucose

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

Criteria:

Inclusion Criteria:

- Patient has type 2 diabetes and is at least 18 years of age and no older than 78

years of age

- Patient is male or is a female who is unlikely to conceive children

- Patient is on stable doses of a PPARg agonist and metformin OR metformin and a

sulfonylurea agent

Exclusion Criteria:

- Patient has Type 1 diabetes

- Patient has taken a DPP-4 inhibitor or a GLP-1 analogue

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

started a weight loss medication within 8 weeks of screening

- Patient has had surgery within 30 days of screening or has major surgery planned

during the study

- Patient is on or is likely to require treatment with corticosteroids for more than 2

weeks

- Patient has a history of active liver disease, including hepatitis B or C, cirrhosis,

or gallbladder disease

- Patient is HIV positive

- Patient has congestive heart failure, or has had new or worsening symptoms of

coronary heart disease within 3 months prior to screening

- Patient has had acute coronary syndrome, coronary artery intervention, or stroke

within 3 months of screening

- Patient has severe active peripheral vascular disease

- Patient has a history of cancer or blood disorder

- Patient is pregnant or breast feeding

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

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

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

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

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

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

Call for Information, Scottsdale, Arizona 85251, United States; Recruiting

Call for Information, Phoenix, Arizona 85020, United States; Recruiting

Call for Information, Litchfield Park, Arizona 85340, United States; Recruiting

Call for Information, Chandler, Arizona 85225, United States; Recruiting

Call for Information, Norwalk, California 90650, United States; Recruiting

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

Call for Information, Denver, Colorado 80239-3133, United States; Recruiting

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

Call for Information, Naranja, Florida 33032, United States; Recruiting

Call for Information, Fleming Island, Florida 32003, United States; Recruiting

Call for Information, Coral Gables, Florida 33134, United States; Recruiting

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

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

Call for Information, Idaho Falls, Idaho 83404-7596, United States; Recruiting

Call for Information, Evansville, Indiana 47710, United States; Recruiting

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

Call for Information, Saint Clair Shores, Michigan 48081, United States; Recruiting

Call for Information, Edina, Minnesota 55435, United States; Recruiting

Call for Information, Saint Louis, Missouri 63141, United States; Recruiting

Call for Information, Saint Louis, Missouri 63128, United States; Recruiting

Call for Information, Freeport, New York 11520, United States; Recruiting

Call for Information, Dayton, Ohio 45406, United States; Recruiting

Call for Information, Columbus, Ohio 43212, United States; Recruiting

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

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

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

Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605

Call for Information, Florence, South Carolina 29501, United States; Recruiting

Call for Information, Irving, Texas 75039, United States; Recruiting

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

Call for Information, Norfolk, Virginia 23502, United States; Recruiting

Call for Information, Monroe, Washington 98272, United States; Recruiting

Call for Information, Federal Way, Washington 98003, 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: April 2009
Ending date: October 2010
Last updated: October 14, 2009