Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes



Status:Active, not recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 17
Updated:4/21/2016
Start Date:June 2011
End Date:April 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin
in pediatric patients with type 2 diabetes.


Inclusion Criteria:

- Male and female patients eligible if 10 years of age, up to 17 years and 32 weeks of
age at the time of randomization.

- HbA1c ≥7.0% and ≤10.5%

Exclusion Criteria:

- Current use of anti-diabetic medications or use within the specified timeframe prior
to screening.
We found this trial at
38
sites
Winthrop University Hospital
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Akron, Ohio 44308
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Akron, OH
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Athens, Ohio 45701
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Athens, OH
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Aurora, Colorado 80045
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Billings, Montana 59101
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Birmingham, Alabama 35294
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Birmingham, AL
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Boca Raton, Florida 33486
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Boca Raton, FL
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Buffalo, New York 14215
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Buffalo, NY
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Chicago, Illinois 60637
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Chicago, IL
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Columbus Research Foundation
Columbus, Georgia 31904
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Columbus, GA
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Alzohaili Medical Consultants
Dearborn, Michigan 48124
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Dearborn, MI
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Utmb
706 Holiday Drive
Galveston, Texas 77555
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Galveston, TX
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Local Institution
Greenville, North Carolina 27834
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Greenville, NC
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Gresham, Oregon 97030
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Gresham, OR
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Local Institution
Hackensack, New Jersey 07601
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Hackensack, NJ
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Pediatric Endocrinology
Hollywood, Florida 33021
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Hollywood, FL
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Local Institution
Kingsport, Tennessee 37660
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Kingsport, TN
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Neufeld Medical Group
Los Angeles, California 90048
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Los Angeles, CA
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Methodist Le Bonheur Hlthcare
Memphis, Tennessee 38103
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Memphis, TN
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Lifedoc-Lifestyle Diab&Obescare
Memphis, Tennessee 38119
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Memphis, TN
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Local Institution
Miami, Florida 33136
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Miami, FL
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Local Institution
Miami, Florida 33136
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Miami, FL
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Local Institution
Miami, Florida 33136
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Miami, FL
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UMDNJ-RWJ Medical School
New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Local Institution
New Orleans, Louisiana 70118
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New Orleans, LA
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Local Institution
Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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St. James Ctr For Diabetes
Olympia Fields, Illinois 60461
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Olympia Fields, IL
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Local Institution
Orlando, Florida 32803
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Orlando, FL
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Endocrine Associates of Dallas
Plano, Texas 75093
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Plano, TX
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Va Commonwealth University (Vcu) Health Systems
Richmond, Virginia 23219
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Richmond, VA
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Rosario, Santa Fe
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Rosario,
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Sacramento, California 95819
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Sacramento, CA
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Saint Louis, Missouri 63104
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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Seattle, Washington 98109
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Seattle, WA
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Wright, Nancy
Tallahassee, Florida 32308
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Tampa, Florida 33612
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Ventura, California 93003
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Ventura, CA
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