A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

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:
NCT01434186
First received: September 13, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo matching with Saxagliptin
Drug: Metformin IR
Drug: Metformin XR
Drug: Saxagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean change in Glycosylated hemoglobin (HbA1c) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in 2-hour Postprandial Glucose (PPG) Area under the curve (AUC) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • Mean change in FPG (Fasting plasma glucose) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • Percent of subjects with HbA1c < 7% in the short term treatment period [ Time Frame: At Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: May 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Saxagliptin + Metformin IR Drug: Metformin IR
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
Drug: Saxagliptin
Tablet, Oral, 2.5 mg for body weight 30kg to ≤ 50kg, Daily, Day 1 through week 52
Other Name: BMS-477118
Drug: Saxagliptin
Tablet, Oral, 5 mg for the body weight >50 kg, Daily, Day 1 through week 52
Other Name: BMS-477118
Experimental: Arm 2: Placebo for Saxagliptin + Metformin IR Drug: Placebo matching with Saxagliptin
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
Drug: Metformin IR
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
Experimental: Arm 3: Saxagliptin + Metformin XR Drug: Metformin XR
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
Drug: Saxagliptin
Tablet, Oral, 2.5 mg for body weight 30kg to ≤ 50kg, Daily, Day 1 through week 52
Other Name: BMS-477118
Drug: Saxagliptin
Tablet, Oral, 5 mg for the body weight >50 kg, Daily, Day 1 through week 52
Other Name: BMS-477118
Experimental: Arm 4: Placebo for Saxagliptin + Metformin XR Drug: Placebo matching with Saxagliptin
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
Drug: Metformin XR
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52

  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 30 weeks of age at the time of screening
  • Previously diagnosed as having type 2 diabetes
  • HbA1c ≥7.0% and ≤10.5%
  • Body weight ≥ 30 kg
  • Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
  • Women must have a negative serum or urine pregnancy test
  • Women must not be breastfeeding

Exclusion Criteria:

  • Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
  • Fasting plasma glucose (FPG) > 255 mg/dL
  • Diabetic ketoacidosis (DKA) within 6 months of study entry
  • Abnormal renal function
  • Active liver disease
  • Anemia
  • An abnormal Thyroid Stimulating Hormone (TSH)
  • Creatinine kinase (CK) ≥ 3X ULN
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434186

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
Uab Pediatric Endocrinology Recruiting
Birmingham, Alabama, United States, 35233
Contact: Gail Mick, Site 1051    205-996-9569      
United States, California
Neufeld Medical Group Recruiting
Los Angeles, California, United States, 90048
Contact: Naomi Neufeld, Site 1039    310-652-2531      
Local Institution Not yet recruiting
Sacramento, California, United States, 95819
Contact: Site 1002         
Rady Children'S Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Ron Newfield, Site 1012    858-966-8940      
Local Institution Not yet recruiting
Ventura, California, United States, 93003
Contact: Site 1042         
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 1034         
United States, Florida
Local Institution Not yet recruiting
Boca Raton, Florida, United States, 33432
Contact: Site 1008         
Miami Children'S Hospital Suspended
Miami, Florida, United States, 33155
Local Institution Not yet recruiting
Miami, Florida, United States, 33125
Contact: Site 1024         
Wright, Nancy Recruiting
Tallahassee, Florida, United States, 32308
Contact: Nancy Wright, Site 1015    850-656-3361      
United States, Georgia
Emory Healthcare-Children'S Hospital Suspended
Atlanta, Georgia, United States, 30322
Columbus Research Foundation Recruiting
Columbus, Georgia, United States, 31904
Contact: Steven Leichter, Md, Site 5306    706-322-1700      
United States, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Site 1016         
Local Institution Not yet recruiting
Olympia Fields, Illinois, United States, 60461
Contact: Site 1045         
United States, Michigan
Alzohaili Medical Consultants Recruiting
Dearborn, Michigan, United States, 48124
Contact: Opada Alzohaili, Site 1043    313-581-8903      
United States, Minnesota
Childrens Hospitals And Clinics Of Minnesota Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Mary Jennifer Abuzzahab, Site 1032    651-220-6254      
United States, Missouri
Local Institution Not yet recruiting
Columbia, Missouri, United States, 65212
Contact: Site 1033         
Local Institution Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site 1049         
United States, Montana
Local Institution Not yet recruiting
Billings, Montana, United States, 59101
Contact: Site 1000         
United States, New Jersey
Local Institution Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site 1041         
Local Institution Not yet recruiting
Livingston, New Jersey, United States, 07039
Contact: Site 1036         
Local Institution Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Site 1025         
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14222
Contact: Site 1001         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Siham Accacha, Site 1031    516-663-9582      
United States, Ohio
Local Institution Not yet recruiting
Athens, Ohio, United States, 45701
Contact: Site 1013         
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Site 1035         
Local Institution Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Site 1006         
United States, Oklahoma
Local Institution Not yet recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Site 1030         
United States, Tennessee
Local Institution Not yet recruiting
Memphis, Tennessee, United States, 38103
Contact: Site 1007         
Local Institution Not yet recruiting
Memphis, Tennessee, United States, 38119
Contact: Site 1052         
United States, Texas
Local Institution Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Site 1020         
Local Institution Not yet recruiting
Galveston, Texas, United States, 77555
Contact: Site 1017         
Local Institution Not yet recruiting
Plano, Texas, United States, 75093
Contact: Site 1053         
The University Of Texas Health Sci Ctr-San Antonio Suspended
San Antonio, Texas, United States, 78284
United States, Virginia
Local Institution Not yet recruiting
Richmond, Virginia, United States, 23219
Contact: Site 1018         
Argentina
Local Institution Suspended
Rosario, Santa Fe, Argentina, 2000
Local Institution Suspended
Buenos Aires, Argentina, C1425DUC
Belgium
Local Institution Suspended
Brussel, Belgium, 1090
Local Institution Recruiting
Bruxelles, Belgium, 1020
Contact: Site 3205         
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 3203         
Local Institution Recruiting
Yvoir, Belgium, 5530
Contact: Site 3200         
Canada, Alberta
Local Institution Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Site 1101         
India
Local Institution Not yet recruiting
Visakhapatnam, Andhra Pradesh, India, 530002
Contact: Site 4105         
Local Institution Not yet recruiting
Visakhapatnam, Andhra Pradesh, India, 530002
Contact: Site 4104         
Local Institution Not yet recruiting
Mysore, Karnataka, India, 570010
Contact: Site 4109         
Local Institution Recruiting
Bangalore, India, 560003
Contact: Site 4108         
Local Institution Not yet recruiting
Chennai, India, 600013
Contact: Site 4101         
Local Institution Not yet recruiting
Hubli, India, 580023
Contact: Site 4110         
Local Institution Not yet recruiting
Mysore, India, 570011
Contact: Site 4103         
Israel
Local Institution Recruiting
Beer-sheva, Israel, 84101
Contact: Site 5000         
Local Institution Not yet recruiting
Jerusalem, Israel, 91240
Contact: Site 5001         
Local Institution Recruiting
Petah Tikva, Israel, 49202
Contact: Site 5004         
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 5003         
Italy
Local Institution Suspended
Bari, Italy, 70124
Local Institution Not yet recruiting
Chieti, Italy, 66100
Contact: Site 3002         
Local Institution Not yet recruiting
Firenze, Italy, 50139
Contact: Site 3003         
Local Institution Recruiting
Latina, Italy, 04100
Contact: Site 3001         
Local Institution Not yet recruiting
Milano, Italy, 20157
Contact: Site 3011         
Local Institution Suspended
Milano, Italy, 20133
Local Institution Not yet recruiting
Modena, Italy, 41100
Contact: Site 3009         
Local Institution Not yet recruiting
Napoli, Italy, 80138
Contact: Site 3004         
Local Institution Not yet recruiting
Palermo, Italy, 90127
Contact: Site 3008         
Local Institution Not yet recruiting
Roma, Italy, 00165
Contact: Site 3007         
Local Institution Not yet recruiting
Torino, Italy, 10126
Contact: Site 3000         
Mexico
Local Institution Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Contact: Site 2001         
Local Institution Not yet recruiting
Merida, Yucatan, Mexico, 97070
Contact: Site 2005         
Local Institution Not yet recruiting
Aguascalientes, Mexico, 20230
Contact: Site 2008         
Local Institution Not yet recruiting
Durango, Mexico, 34270
Contact: Site 2006         
Local Institution Not yet recruiting
Mexico D. F., Mexico, 6700
Contact: Site 2009         
Local Institution Not yet recruiting
Veracruz, Mexico, 91910
Contact: Site 2003         
South Africa
Local Institution Not yet recruiting
Benoni, Gauteng, South Africa, 1500
Contact: Site 5202         
Local Institution Recruiting
Eersterus, Gauteng, South Africa, 0022
Contact: Site 5207         
Local Institution Recruiting
Pretoria, Gauteng, South Africa, 0084
Contact: Site 5205         
Local Institution Not yet recruiting
Dundee, Kwa Zulu Natal, South Africa, 3000
Contact: Site 5201         
Local Institution Recruiting
Durban, Kwa Zulu Natal, South Africa, 4001
Contact: Site 5307         
Local Institution Suspended
Thabazimbi, Limpopo, South Africa, 0380
Local Institution Not yet recruiting
Parow, Western Cape, South Africa, 7550
Contact: Site 5203         
Taiwan
Local Institution Not yet recruiting
Taichung, Taiwan, 404
Contact: Site 4201         
Local Institution Recruiting
Taipei, Taiwan, 100
Contact: Site 4202         
United Kingdom
Local Institution Not yet recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Contact: Site 3105         
Local Institution Recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Contact: Site 3101         
Local Institution Not yet recruiting
Leicester, United Kingdom, LE15WW
Contact: Site 3106         
Local Institution Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Site 3100         
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: NCT01434186     History of Changes
Other Study ID Numbers: CV181-147, 2010-024568-16
Study First Received: September 13, 2011
Last Updated: April 16, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
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: FSI Scientific Center of Expertise of Medical Application
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
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 Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board
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