Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Saxagliptin

U.S. FDA Resources

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:	January 2015
Estimated Primary Completion Date:	January 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204775

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 51 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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:	March 28, 2013
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Office of Clinical Trials - Therapeutic Products Directorate 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: The Swedish Data Inspection Board Sweden: Central Ethics Board 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
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 May 19, 2013