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
Overview[ - collapse ][ - ]
| Purpose | To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Placebo matching with Saxagliptin Drug: Metformin IR Drug: Metformin XR Drug: Saxagliptin Drug: Saxagliptin |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01434186 |
| First Received | September 13, 2011 |
| Last Updated | April 16, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 13, 2011 |
|---|---|
| Last Updated Date | April 16, 2014 |
| Start Date | May 2012 |
| Estimated Primary Completion Date | July 2017 |
| Current 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] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief 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 |
|---|---|
| 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 |
| Brief Summary | To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | 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 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 Names: BMS-477118Drug: Saxagliptin Tablet, Oral, 5 mg for the body weight >50 kg, Daily, Day 1 through week 52 Other Names: BMS-477118 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 224 |
| Estimated Completion Date | July 2017 |
| Estimated Primary Completion Date | September 2016 |
| Eligibility 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 |
| Gender | Both |
| Ages | 10 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com |
| Location Countries | United States, Argentina, Belgium, Canada, India, Israel, Italy, Mexico, South Africa, Taiwan, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01434186 |
|---|---|
| Other Study ID Numbers | CV181-147 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | AstraZeneca |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Uab Pediatric Endocrinology | Birmingham, Alabama, United States, 35233 Contact: Gail Mick, Site 1051 | 205-996-9569Recruiting |
|---|---|
| Neufeld Medical Group | Los Angeles, California, United States, 90048 Contact: Naomi Neufeld, Site 1039 | 310-652-2531Recruiting |
| Local Institution | Sacramento, California, United States, 95819 Contact: Site 1002Not yet recruiting |
| Rady Children'S Hospital - San Diego | San Diego, California, United States, 92123 Contact: Ron Newfield, Site 1012 | 858-966-8940Recruiting |
| Local Institution | Ventura, California, United States, 93003 Contact: Site 1042Not yet recruiting |
| Local Institution | Aurora, Colorado, United States, 80045 Contact: Site 1034Not yet recruiting |
| Local Institution | Boca Raton, Florida, United States, 33432 Contact: Site 1008Not yet recruiting |
| Miami Children'S Hospital | Miami, Florida, United States, 33155 Suspended |
| Local Institution | Miami, Florida, United States, 33125 Contact: Site 1024Not yet recruiting |
| Wright, Nancy | Tallahassee, Florida, United States, 32308 Contact: Nancy Wright, Site 1015 | 850-656-3361Recruiting |
| Emory Healthcare-Children'S Hospital | Atlanta, Georgia, United States, 30322 Suspended |
| Columbus Research Foundation | Columbus, Georgia, United States, 31904 Contact: Steven Leichter, Md, Site 5306 | 706-322-1700Recruiting |
| Local Institution | Chicago, Illinois, United States, 60611 Contact: Site 1016Not yet recruiting |
| Local Institution | Olympia Fields, Illinois, United States, 60461 Contact: Site 1045Not yet recruiting |
| Alzohaili Medical Consultants | Dearborn, Michigan, United States, 48124 Contact: Opada Alzohaili, Site 1043 | 313-581-8903Recruiting |
| Childrens Hospitals And Clinics Of Minnesota | St. Paul, Minnesota, United States, 55102 Contact: Mary Jennifer Abuzzahab, Site 1032 | 651-220-6254Recruiting |
| Local Institution | Columbia, Missouri, United States, 65212 Contact: Site 1033Not yet recruiting |
| Local Institution | Saint Louis, Missouri, United States, 63110 Contact: Site 1049Not yet recruiting |
| Local Institution | Billings, Montana, United States, 59101 Contact: Site 1000Not yet recruiting |
| Local Institution | Hackensack, New Jersey, United States, 07601 Contact: Site 1041Not yet recruiting |
| Local Institution | Livingston, New Jersey, United States, 07039 Contact: Site 1036Not yet recruiting |
| Local Institution | New Brunswick, New Jersey, United States, 08901 Contact: Site 1025Not yet recruiting |
| Local Institution | Buffalo, New York, United States, 14222 Contact: Site 1001Not yet recruiting |
| Winthrop University Hospital | Mineola, New York, United States, 11501 Contact: Siham Accacha, Site 1031 | 516-663-9582Recruiting |
| Local Institution | Athens, Ohio, United States, 45701 Contact: Site 1013Not yet recruiting |
| Local Institution | Cleveland, Ohio, United States, 44195 Contact: Site 1035Not yet recruiting |
| Local Institution | Columbus, Ohio, United States, 43205 Contact: Site 1006Not yet recruiting |
| Local Institution | Oklahoma City, Oklahoma, United States, 73103 Contact: Site 1030Not yet recruiting |
| Local Institution | Memphis, Tennessee, United States, 38103 Contact: Site 1007Not yet recruiting |
| Local Institution | Memphis, Tennessee, United States, 38119 Contact: Site 1052Not yet recruiting |
| Local Institution | Dallas, Texas, United States, 75390 Contact: Site 1020Not yet recruiting |
| Local Institution | Galveston, Texas, United States, 77555 Contact: Site 1017Not yet recruiting |
| Local Institution | Plano, Texas, United States, 75093 Contact: Site 1053Not yet recruiting |
| The University Of Texas Health Sci Ctr-San Antonio | San Antonio, Texas, United States, 78284 Suspended |
| Local Institution | Richmond, Virginia, United States, 23219 Contact: Site 1018Not yet recruiting |
| Local Institution | Rosario, Santa Fe, Argentina, 2000 Suspended |
| Local Institution | Buenos Aires, Argentina, C1425DUC Suspended |
| Local Institution | Brussel, Belgium, 1090 Suspended |
| Local Institution | Bruxelles, Belgium, 1020 Contact: Site 3205Recruiting |
| Local Institution | Leuven, Belgium, 3000 Contact: Site 3203Recruiting |
| Local Institution | Yvoir, Belgium, 5530 Contact: Site 3200Recruiting |
| Local Institution | Calgary, Alberta, Canada, T3B 6A8 Contact: Site 1101Recruiting |
| Local Institution | Visakhapatnam, Andhra Pradesh, India, 530002 Contact: Site 4105Not yet recruiting |
| Local Institution | Visakhapatnam, Andhra Pradesh, India, 530002 Contact: Site 4104Not yet recruiting |
| Local Institution | Mysore, Karnataka, India, 570010 Contact: Site 4109Not yet recruiting |
| Local Institution | Bangalore, India, 560003 Contact: Site 4108Recruiting |
| Local Institution | Chennai, India, 600013 Contact: Site 4101Not yet recruiting |
| Local Institution | Hubli, India, 580023 Contact: Site 4110Not yet recruiting |
| Local Institution | Mysore, India, 570011 Contact: Site 4103Not yet recruiting |
| Local Institution | Beer-sheva, Israel, 84101 Contact: Site 5000Recruiting |
| Local Institution | Jerusalem, Israel, 91240 Contact: Site 5001Not yet recruiting |
| Local Institution | Petah Tikva, Israel, 49202 Contact: Site 5004Recruiting |
| Local Institution | Ramat Gan, Israel, 52621 Contact: Site 5003Recruiting |
| Local Institution | Bari, Italy, 70124 Suspended |
| Local Institution | Chieti, Italy, 66100 Contact: Site 3002Not yet recruiting |
| Local Institution | Firenze, Italy, 50139 Contact: Site 3003Not yet recruiting |
| Local Institution | Latina, Italy, 04100 Contact: Site 3001Recruiting |
| Local Institution | Milano, Italy, 20157 Contact: Site 3011Not yet recruiting |
| Local Institution | Milano, Italy, 20133 Suspended |
| Local Institution | Modena, Italy, 41100 Contact: Site 3009Not yet recruiting |
| Local Institution | Napoli, Italy, 80138 Contact: Site 3004Not yet recruiting |
| Local Institution | Palermo, Italy, 90127 Contact: Site 3008Not yet recruiting |
| Local Institution | Roma, Italy, 00165 Contact: Site 3007Not yet recruiting |
| Local Institution | Torino, Italy, 10126 Contact: Site 3000Not yet recruiting |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64710 Contact: Site 2001Not yet recruiting |
| Local Institution | Merida, Yucatan, Mexico, 97070 Contact: Site 2005Not yet recruiting |
| Local Institution | Aguascalientes, Mexico, 20230 Contact: Site 2008Not yet recruiting |
| Local Institution | Durango, Mexico, 34270 Contact: Site 2006Not yet recruiting |
| Local Institution | Mexico D. F., Mexico, 6700 Contact: Site 2009Not yet recruiting |
| Local Institution | Veracruz, Mexico, 91910 Contact: Site 2003Not yet recruiting |
| Local Institution | Benoni, Gauteng, South Africa, 1500 Contact: Site 5202Not yet recruiting |
| Local Institution | Eersterus, Gauteng, South Africa, 0022 Contact: Site 5207Recruiting |
| Local Institution | Pretoria, Gauteng, South Africa, 0084 Contact: Site 5205Recruiting |
| Local Institution | Dundee, Kwa Zulu Natal, South Africa, 3000 Contact: Site 5201Not yet recruiting |
| Local Institution | Durban, Kwa Zulu Natal, South Africa, 4001 Contact: Site 5307Recruiting |
| Local Institution | Thabazimbi, Limpopo, South Africa, 0380 Suspended |
| Local Institution | Parow, Western Cape, South Africa, 7550 Contact: Site 5203Not yet recruiting |
| Local Institution | Taichung, Taiwan, 404 Contact: Site 4201Not yet recruiting |
| Local Institution | Taipei, Taiwan, 100 Contact: Site 4202Recruiting |
| Local Institution | Sheffield, South Yorkshire, United Kingdom, S10 2TH Contact: Site 3105Not yet recruiting |
| Local Institution | Birmingham, West Midlands, United Kingdom, B4 6NH Contact: Site 3101Recruiting |
| Local Institution | Leicester, United Kingdom, LE15WW Contact: Site 3106Not yet recruiting |
| Local Institution | Manchester, United Kingdom, M13 9WL Contact: Site 3100Recruiting |