Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2014 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01204775
First received: September 16, 2010
Last updated: February 19, 2015
Last verified: April 2014
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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:
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: | April 2017 |
| Estimated Primary Completion Date: | December 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:
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
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: NCT01204775
Show 74 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204775
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 74 Study Locations
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: | NCT01204775 History of Changes |
| Other Study ID Numbers: | CV181-058, 2010-020360-38 |
| Study First Received: | September 16, 2010 |
| Last Updated: | February 19, 2015 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration 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: 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: 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 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