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

This study is currently recruiting participants.
Verified April 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01204775
First received: September 16, 2010
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 ]

Estimated Enrollment: 136
Study Start Date: June 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204775

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alabama
Local Institution Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Site 1040         
United States, California
Neufeld Medical Group Recruiting
Los Angeles, California, United States, 90048
Contact: Naomi Neufeld, Site 1023    310-652-2531      
Local Institution Not yet recruiting
Sacramento, California, United States, 95819
Contact: Site 1025         
Local Institution Not yet recruiting
San Diego, California, United States, 92123
Contact: Site 1024         
Local Institution Not yet recruiting
Ventura, California, United States, 93003
Contact: Site 1011         
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 1043         
United States, Florida
Local Institution Not yet recruiting
Boca Raton, Florida, United States, 33432
Contact: Site 1060         
Pediatric Endocrinology Recruiting
Hollywood, Florida, United States, 33021
Contact: Bethel Steindel-Kopp, Site 1047    954-265-6984      
Local Institution Not yet recruiting
Miami, Florida, United States, 33136
Contact: Site 1041         
Local Institution Not yet recruiting
Miami, Florida, United States, 33125
Contact: Site 1070         
Local Institution Not yet recruiting
Miami, Florida, United States, 33155
Contact: Site 1016         
Local Institution Not yet recruiting
Orlando, Florida, United States, 32806
Contact: Site 1071         
Wright, Nancy Recruiting
Tallahassee, Florida, United States, 32308
Contact: Nancy Wright, Site 1033    850-656-3361      
Local Institution Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Site 1042         
United States, Georgia
Columbus Research Foundation Recruiting
Columbus, Georgia, United States, 31904
Contact: Steven Leichter, Md, Site 5413    706-322-1700      
United States, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Site 1068         
St. James Ctr For Diabetes Recruiting
Olympia Fields, Illinois, United States, 60461
Contact: Arcot Dwarakanathan, Site 1062    708-679-2727      
United States, Louisiana
Local Institution Not yet recruiting
New Orleans, Louisiana, United States, 70118
Contact: Site 1059         
United States, Michigan
Alzohaili Medical Consultants Recruiting
Dearborn, Michigan, United States, 48124
Contact: Opada Alzohaili, Site 1004    313-581-8903      
United States, Missouri
Local Institution Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site 1056         
United States, Montana
Local Institution Not yet recruiting
Billings, Montana, United States, 59101
Contact: Site 1058         
United States, New Jersey
Local Institution Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site 1002         
Local Institution Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Site 1021         
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14222
Contact: Site 1039         
Local Institution Not yet recruiting
Mineola, New York, United States, 11501
Contact: Site 1001         
United States, North Carolina
Local Institution Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact: Site 1064         
United States, Ohio
Local Institution Not yet recruiting
Akron, Ohio, United States, 44308
Contact: Site 1014         
Local Institution Not yet recruiting
Athens, Ohio, United States, 45701
Contact: Site 1032         
United States, Oklahoma
Local Institution Not yet recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Site 1072         
United States, Oregon
Local Institution Not yet recruiting
Gresham, Oregon, United States, 97030
Contact: Site 1009         
United States, Tennessee
Local Institution Not yet recruiting
Kingsport, Tennessee, United States, 37660
Contact: Site 1019         
Lifedoc-Lifestyle Diab&Obescare Recruiting
Memphis, Tennessee, United States, 38119
Contact: Pedro Velasquez-Mieyer, Site 5407    901-683-0024      
Methodist Le Bonheur Hlthcare Recruiting
Memphis, Tennessee, United States, 38103
Contact: Robert Ferry, Site 1036    901-287-6221      
United States, Texas
Utmb Recruiting
Galveston, Texas, United States, 77555
Contact: Phillip Lee, Site 1069    409-772-5278      
Endocrine Associates Of Dallas P.A. Recruiting
Plano, Texas, United States, 75093
Contact: Heidi Shea, Site 5410    972-867-4658      
United States, Virginia
Va Commonwealth University (Vcu) Health Systems Recruiting
Richmond, Virginia, United States, 23219
Contact: Gary Francis, Site 1015    804-828-6703      
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Site 1010         
Argentina
Local Institution Not yet recruiting
Rosario, Santa Fe, Argentina, 2000
Contact: Site 2004         
Local Institution Not yet recruiting
Buenos Aires, Argentina, C1425DUC
Contact: Site 2001         
Belgium
Local Institution Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Site 3601         
Local Institution Not yet recruiting
Brussel, Belgium, 1090
Contact: Site 3602         
Local Institution Not yet recruiting
Bruxelles, Belgium, 1020
Contact: Site 3605         
Local Institution Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Site 3606         
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 3604         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Site 1044         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Site 1051         
India
Local Institution Not yet recruiting
Kamal, Haryana, India, 132001
Contact: Site 4106         
Israel
Local Institution Recruiting
Beer-sheva, Israel, 84101
Contact: Site 5301         
Local Institution Recruiting
Haifa, Israel, 31096
Contact: Site 5304         
Local Institution Recruiting
Jerusalem, Israel, 91240
Contact: Site 5306         
Local Institution Recruiting
Petah Tikva, Israel, 49202
Contact: Site 5303         
Italy
Local Institution Not yet recruiting
Chieti, Italy, 66013
Contact: Site 3108         
Local Institution Not yet recruiting
Firenze, Italy, 50139
Contact: Site 3107         
Local Institution Recruiting
Milano, Italy, 20157
Contact: Site 3111         
Local Institution Not yet recruiting
Modena, Italy, 41100
Contact: Site 3104         
Local Institution Recruiting
Napoli, Italy, 80138
Contact: Site 3103         
Local Institution Recruiting
Palermo, Italy, 90127
Contact: Site 3102         
Local Institution Recruiting
Roma, Italy, 00185
Contact: Site 3100         
Local Institution Not yet recruiting
Tento, Italy, 38100
Contact: Site 3110         
Local Institution Not yet recruiting
Torino, Italy, 10126
Contact: Site 3109         
Russian Federation
Local Institution Recruiting
Ekaterinburg, Russian Federation, 620149
Contact: Site 5402         
Local Institution Recruiting
Moscow, Russian Federation, 117036
Contact: Site 5403         
Local Institution Recruiting
Novosibirsk, Russian Federation, 630076
Contact: Site 5404         
Local Institution Recruiting
Saint Petersburg, Russian Federation, 194100
Contact: Site 5401         
South Africa
Local Institution Not yet recruiting
Benoni, Gauteng, South Africa, 1500
Contact: Site 5103         
Local Institution Not yet recruiting
Potchefstroom, Gauteng, South Africa, 2531
Contact: Site 5102         
Local Institution Recruiting
Pretoria, Gauteng, South Africa, 0022
Contact: Site 5412         
Local Institution Not yet recruiting
Dundee, Kwa Zulu Natal, South Africa, 3000
Contact: Site 5101         
Local Institution Recruiting
Durban, Kwa Zulu Natal, South Africa, 4001
Contact: Site 5408         
Local Institution Not yet recruiting
Thabazimbi, North West Province, South Africa, 0380
Contact: Site 5100         
Local Institution Recruiting
Cape Town, Western Cape, South Africa, 7550
Contact: Site 5104         
Taiwan
Local Institution Recruiting
Taichung, Taiwan, 40447
Contact: Site 4201         
Local Institution Recruiting
Taipei, Taiwan, 100
Contact: Site 4202         
Turkey
Local Institution Not yet recruiting
Adana, Turkey, 01120
Contact: Site 5418         
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01204775     History of Changes
Other Study ID Numbers: CV181-058, 2010-020360-38
Study First Received: September 16, 2010
Last Updated: April 22, 2014
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
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014