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 - Full Text View

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:

Drug Information available for: Metformin Metformin hydrochloride Saxagliptin

U.S. FDA Resources

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:	November 2011
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	January 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

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

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 #.

Show 83 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

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:	February 19, 2015
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, Type 2 Diabetes Mellitus 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 March 03, 2015