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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01434186
First received: September 13, 2011
Last updated: July 5, 2016
Last verified: July 2016
  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 ]

Enrollment: 7
Study Start Date: November 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: July 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   (Child)
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
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: NCT01434186

  Hide Study Locations
Locations
United States, Alabama
Uab Pediatric Endocrinology
Birmingham, Alabama, United States, 35233
United States, California
Neufeld Medical Group
Los Angeles, California, United States, 90048
Local Institution
Sacramento, California, United States, 95819
Rady Children'S Hospital - San Diego
San Diego, California, United States, 92123
Local Institution
Ventura, California, United States, 93003
United States, Colorado
Children'S Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Local Institution
Boca Raton, Florida, United States, 33432
Local Institution
Miami, Florida, United States, 33125
Miami Children'S Hospital
Miami, Florida, United States, 33155
Wright, Nancy
Tallahassee, Florida, United States, 32308
United States, Georgia
Emory Healthcare-Children'S Hospital
Atlanta, Georgia, United States, 30322
Columbus Research Foundation
Columbus, Georgia, United States, 31904
United States, Illinois
Local Institution
Chicago, Illinois, United States, 60611
Local Institution
Olympia Fields, Illinois, United States, 60461
United States, Michigan
Alzohaili Medical Consultants
Dearborn, Michigan, United States, 48124
United States, Minnesota
Childrens Hospitals And Clinics Of Minnesota
St. Paul, Minnesota, United States, 55102
United States, Missouri
Local Institution
Columbia, Missouri, United States, 65212
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
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
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, Ohio
Local Institution
Athens, Ohio, United States, 45701
Local Institution
Cleveland, Ohio, United States, 44195
Local Institution
Columbus, Ohio, United States, 43205
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States, 73103
United States, Tennessee
University Of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
Local Institution
Memphis, Tennessee, United States, 38119
United States, Texas
Local Institution
Dallas, Texas, United States, 75390
Local Institution
Galveston, Texas, United States, 77555
Local Institution
Plano, Texas, United States, 75093
The University Of Texas Health Sci Ctr-San Antonio
San Antonio, Texas, United States, 78284
United States, Virginia
Local Institution
Richmond, Virginia, United States, 23219
Argentina
Local Institution
Rosario, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, C1425DUC
Belgium
Local Institution
Brussel, Belgium, 1090
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Bruxelles, Belgium, 1020
Local Institution
Leuven, Belgium, 3000
Local Institution
Yvoir, Belgium, 5530
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T3B 6A8
India
Local Institution
Visakhapatnam, Andhra Pradesh, India, 530002
Local Institution
Mysore, Karnataka, India, 570010
Local Institution
Bangalore, India, 560003
Local Institution
Chennai, India, 600013
Local Institution
Hubli, India, 580023
Local Institution
Mysore, India, 570011
Israel
Local Institution
Beer-sheva, Israel, 84101
Local Institution
Jerusalem, Israel, 91240
Local Institution
Petah Tikva, Israel, 49202
Local Institution
Ramat Gan, Israel, 52621
Italy
Local Institution
Bari, Italy, 70124
Local Institution
Chieti, Italy, 66100
Local Institution
Firenze, Italy, 50139
Local Institution
Latina, Italy, 04100
Local Institution
Milano, Italy, 20133
Local Institution
Milano, Italy, 20157
Local Institution
Modena, Italy, 41100
Local Institution
Napoli, Italy, 80138
Local Institution
Palermo, Italy, 90127
Local Institution
Roma, Italy, 00165
Local Institution
Torino, Italy, 10126
Mexico
Local Institution
Monterrey, Nuevo Leon, Mexico, 64710
Local Institution
Merida, Yucatan, Mexico, 97070
Local Institution
Aguascalientes, Mexico, 20230
Local Institution
Durango, Mexico, 34270
Local Institution
Mexico D. F., Mexico, 6700
Local Institution
Veracruz, Mexico, 91910
South Africa
Local Institution
Benoni, Gauteng, South Africa, 1500
Local Institution
Eersterust, Gauteng, South Africa, 0022
Local Institution
Pretoria, Gauteng, South Africa, 0084
Local Institution
Dundee, Kwa Zulu Natal, South Africa, 3000
Local Institution
Durban, Kwa Zulu Natal, South Africa, 4001
Local Institution
Thabazimbi, Limpopo, South Africa, 0380
Local Institution
Parow, Western Cape, South Africa, 7550
Taiwan
Local Institution
Taichung, Taiwan, 404
Local Institution
Taipei, Taiwan, 100
United Kingdom
Local Institution
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Local Institution
Birmingham, West Midlands, United Kingdom, B4 6NH
Local Institution
Leicester, United Kingdom, LE15WW
Local Institution
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: July 5, 2016
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016