Clinical trial NCT00035542: A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Diabetes Mellitus, Type II
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-06
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to see if Glucovance, a medication currently approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and effectively in children 9 to 16 years of age.


Eligibility criteria: Children ages 9-16 years with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, with or without oral hypoglycemic therapy, and have an HbA1c greater than 6.4%

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Childrens's Health System/Dept of PED/Diabetes/Endoncrinology
state: Alabama
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Beverly Hills
country: United States
facility: Hazan, Lydie
state: California
city: Fresno
country: United States
facility: Bautista Research & Medical Center
state: California
city: La Jolla
country: United States
facility: Health Care Link, Inc
state: California
city: Los Angeles
country: United States
facility: Neufeld Medical Group
state: California
city: Los Angeles
country: United States
facility: National Institute Of Clinical Research
state: California
city: Pasadena
country: United States
facility: Pasadena Pediatric Endocrinology Diabetes
state: California
city: Redondo Beach
country: United States
facility: A.R.I. Clinical Trials
state: California
city: Sacramento
country: United States
facility: Sutter Institute For Medical Research
state: California
city: Denver
country: United States
facility: Children's Hospital
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Tallahassee
country: United States
facility: EDU Practice Pediatric Endocrinology
state: Florida
city: Atlanta
country: United States
facility: Southeastern Endocrine and Diabetes
state: Georgia
city: Ewa Beach
country: United States
facility: University of Hawaii/Diabetes Research Group
state: Hawaii
city: Chicago Heights
country: United States
facility: St. James Diabetes Center
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Children's Hospital
state: Illinois
city: Des Moines
country: United States
facility: Raymond Blank Children's Hospital
state: Iowa
city: Louisville
country: United States
facility: Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute
state: Kentucky
city: Easton
country: United States
facility: Bay East Endocrinologists
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Swansea
country: United States
facility: JM Clinical Trials Inc
state: Massachusetts
city: Gulfport
country: United States
facility: Center for Health Management
state: Mississippi
city: St Louis
country: United States
facility: Medex Healthcare Research
state: Missouri
city: Hampton
country: United States
facility: Diabetes, Endocrine & Nutrition Core Physicians
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Jersey City
country: United States
facility: Endocrine & Diabetes Center
state: New Jersey
city: Bronx
country: United States
facility: Montefioe Medical Center - DIV / c/o BRANY
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center / Dept of Endocrinology
state: New York
city: Buffalo
country: United States
facility: Children's Hospital of Buffalo/Kaledia Health Diabetes Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital, Clinical Trials Center
state: New York
city: New York
country: United States
facility: St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester/Dpt Pediatrics, S.M.H.
state: New York
city: Greenville
country: United States
facility: East Carolina University School of Medicine Dept of Pediatrics
state: North Carolina
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Cleveland
country: United States
facility: Metro Health Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Children's Hospital/Dept of Pediatrics
state: Ohio
city: Youngstown
country: United States
facility: Forum Health/Western Reserve/TOD Children's Hospital
state: Ohio
city: Greenville
country: United States
facility: Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology
state: South Carolina
city: Memphis
country: United States
facility: Lebonheur Children's Medical Center
state: Tennessee
city: Corpus Christi
country: United States
facility: South Texas Applied Research
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital/Division of Medical Education/William Riley
state: Texas
city: Houston
country: United States
facility: Tri Quest Research Inc
state: Texas
city: Lackland AFB
country: United States
facility: Wilford Hall USAF Medical Center
state: Texas
city: Lufkin
country: United States
facility: Lance Sloan, MD
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic
state: Texas
city: San Antonio
country: United States
facility: S.A.M. Clinical Research Center
state: Texas
city: Norfolk
country: United States
facility: Monarch Research Associates
state: Virginia
Study officials:
References: