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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: September 16, 2010
Last updated: February 9, 2016
Last verified: February 2016
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes
Drug: Saxagliptin
Drug: Placebo (Saxagliptin)
Drug: Metformin IR
Drug: Placebo (Metformin)
Drug: Metformin (Active Rescue)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare after 16 weeks of oral double-blind treatment the change from baseline in HbA1c achieved with Saxagliptin and placebo [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the AUC change from baseline in 2-hour PPG levels, as determined from samples obtained during Mixed Meal Tolerance Test (MMTT). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
    Area under the curve (AUC), Postprandial Glucose (PPG)

  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the change from baseline in Fasting Plasma Glucose (FPG). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the percent of subjects who achieved Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: June 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saxagliptin or Placebo Drug: Saxagliptin
Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
Other Names:
  • BMS-477118
  • Onglyza
Drug: Placebo (Saxagliptin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
Active Comparator: Metformin IR or Placebo Drug: Metformin IR
Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
Drug: Placebo (Metformin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
Metformin IR
Active Rescue
Drug: Metformin (Active Rescue)
Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01204775

  Hide Study Locations
United States, Alabama
Local Institution
Birmingham, Alabama, United States, 35233
United States, California
Neufeld Medical Group
Los Angeles, California, United States, 90048
Local Institution
Sacramento, California, United States, 95819
Local Institution
San Diego, California, United States, 92123
Local Institution
Ventura, California, United States, 93003
United States, Colorado
Local Institution
Aurora, Colorado, United States, 80045
United States, Florida
Local Institution
Boca Raton, Florida, United States, 33432
Pediatric Endocrinology
Hollywood, Florida, United States, 33021
Local Institution
Miami, Florida, United States, 33125
Local Institution
Miami, Florida, United States, 33136
Local Institution
Miami, Florida, United States, 33155
Local Institution
Orlando, Florida, United States, 32806
Wright, Nancy
Tallahassee, Florida, United States, 32308
Local Institution
Tampa, Florida, United States, 33612
United States, Georgia
Columbus Research Foundation
Columbus, Georgia, United States, 31904
United States, Illinois
Local Institution
Chicago, Illinois, United States, 60611
St. James Ctr For Diabetes
Olympia Fields, Illinois, United States, 60461
United States, Louisiana
Local Institution
New Orleans, Louisiana, United States, 70118
United States, Michigan
Alzohaili Medical Consultants
Dearborn, Michigan, United States, 48124
United States, Missouri
Local Institution
Saint Louis, Missouri, United States, 63110
United States, Montana
Local Institution
Billings, Montana, United States, 59101
United States, New Jersey
Local Institution
Hackensack, New Jersey, United States, 07601
Umdnj-Rwj Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
Local Institution
Buffalo, New York, United States, 14222
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Local Institution
Greenville, North Carolina, United States, 27834
United States, Ohio
Local Institution
Akron, Ohio, United States, 44308
Local Institution
Athens, Ohio, United States, 45701
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Local Institution
Gresham, Oregon, United States, 97030
United States, Tennessee
Local Institution
Kingsport, Tennessee, United States, 37660
Methodist Le Bonheur Hlthcare
Memphis, Tennessee, United States, 38103
Lifedoc-Lifestyle Diab&Obescare
Memphis, Tennessee, United States, 38119
United States, Texas
Galveston, Texas, United States, 77555
Endocrine Associates Of Dallas P.A.
Plano, Texas, United States, 75093
United States, Virginia
Va Commonwealth University (Vcu) Health Systems
Richmond, Virginia, United States, 23219
United States, Washington
Local Institution
Seattle, Washington, United States, 98105
Local Institution
Rosario, Santa Fe, Argentina, 2000
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Buenos Aires, Argentina, C1425DUC
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Yvoir, Namur, Belgium, 5530
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1020
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Bruxelles, Belgium, 1200
Local Institution
Leuven, Belgium, 3000
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 1N4
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3H 1P3
Local Institution
Kamal, Haryana, India, 132001
Local Institution
Beer-sheva, Israel, 84101
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Haifa, Israel, 31096
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Jerusalem, Israel, 91240
Local Institution
Petah Tikva, Israel, 49202
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Chieti, Italy, 66013
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Firenze, Italy, 50139
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Milano, Italy, 20157
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Modena, Italy, 41100
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Napoli, Italy, 80138
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Palermo, Italy, 90127
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Roma, Italy, 00185
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Tento, Italy, 38100
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Torino, Italy, 10126
Russian Federation
Local Institution
Ekaterinburg, Russian Federation, 620149
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Moscow, Russian Federation, 117036
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Novosibirsk, Russian Federation, 630076
Local Institution
Saint Petersburg, Russian Federation, 194100
South Africa
Local Institution
Benoni, Gauteng, South Africa, 1500
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Potchefstroom, Gauteng, South Africa, 2531
Local Institution
Pretoria, Gauteng, South Africa, 0022
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Dundee, Kwa Zulu Natal, South Africa, 3000
Local Institution
Durban, Kwa Zulu Natal, South Africa, 4001
Local Institution
Thabazimbi, North West Province, South Africa, 0380
Local Institution
Cape Town, Western Cape, South Africa, 7550
Local Institution
Taichung, Taiwan, 40447
Local Institution
Taipei, Taiwan, 100
Local Institution
Adana, Turkey, 01120
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01204775     History of Changes
Other Study ID Numbers: CV181-058  2010-020360-38 
Study First Received: September 16, 2010
Last Updated: February 9, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Central Drugs Standard Control Organization
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016