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. (see Contacts and Locations)
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: October 13, 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
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 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         
Umdnj-Rwj Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Ian Marshall, Site 1021    732-235-9378      
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14222
Contact: Site 1039         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Siham Accacha, Site 1001    516-663-9582      
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         
Methodist Le Bonheur Hlthcare Recruiting
Memphis, Tennessee, United States, 38103
Contact: Robert Ferry, Site 1036    901-287-6221      
Lifedoc-Lifestyle Diab&Obescare Recruiting
Memphis, Tennessee, United States, 38119
Contact: Pedro Velasquez-Mieyer, Site 5407    901-683-0024      
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 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: October 13, 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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014