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.

Condition	Treatment or Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: Glucovance (metformin HCl/glyburide)  Drug: metformin HCl  Drug: glyburide	Phase III

Ages Eligible for Study:  9 Years   -   16 Years,  Genders Eligible for Study:  Both

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%

Alabama
      Childrens's Health System/Dept of PED/Diabetes/Endoncrinology, Birmingham,  Alabama,  35233,  United States
Arizona
      Advanced Clinical Therapeutics, Tucson,  Arizona,  85712,  United States
California
      Hazan, Lydie, Beverly Hills,  California,  90211,  United States
      Bautista Research & Medical Center, Fresno,  California,  93721,  United States
      Health Care Link, Inc, La Jolla,  California,  92037,  United States
      Neufeld Medical Group, Los Angeles,  California,  90048,  United States
      A.R.I. Clinical Trials, Redondo Beach,  California,  90277,  United States
      National Institute Of Clinical Research, Los Angeles,  California,  90806,  United States
      Pasadena Pediatric Endocrinology Diabetes, Pasadena,  California,  91105,  United States
      Sutter Institute For Medical Research, Sacramento,  California,  95816,  United States
Colorado
      Children's Hospital, Denver,  Colorado,  80218,  United States
Connecticut
      Connecticut Children's Medical Center, Hartford,  Connecticut,  06106,  United States
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010,  United States
Florida
      EDU Practice Pediatric Endocrinology, Tallahassee,  Florida,  32308,  United States
Georgia
      Southeastern Endocrine and Diabetes, Atlanta,  Georgia,  33028,  United States
Hawaii
      University of Hawaii/Diabetes Research Group, Ewa Beach,  Hawaii,  96706,  United States
Illinois
      St. James Diabetes Center, Chicago Heights,  Illinois,  60411,  United States
      Lutheran General Children's Hospital, Park Ridge,  Illinois,  60068,  United States
Iowa
      Raymond Blank Children's Hospital, Des Moines,  Iowa,  50309,  United States
Kentucky
      Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute, Louisville,  Kentucky,  40217,  United States
Maryland
      Bay East Endocrinologists, Easton,  Maryland,  21601,  United States
Massachusetts
      Joslin Diabetes Center, Boston,  Massachusetts,  02215,  United States
      JM Clinical Trials Inc, Swansea,  Massachusetts,  02777,  United States
Mississippi
      Center for Health Management, Gulfport,  Mississippi,  39501,  United States
Missouri
      Medex Healthcare Research, St. Louis,  Missouri,  63108,  United States
New Hampshire
      Diabetes, Endocrine & Nutrition Core Physicians, Hampton,  New Hampshire,  03842,  United States
New Jersey
      Endocrine & Diabetes Center, Jersey City,  New Jersey,  07306,  United States
      Hackensack Medical Center, Hackensack,  New Jersey,  07601,  United States
New York
      Vassar Brothers Hospital, Poughkeepsie,  New York,  12603,  United States
      St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program, New York,  New York,  10023,  United States
      University of Rochester/Dpt Pediatrics, S.M.H., Rochester,  New York,  14642,  United States
      SUNY Downstate Medical Center / Dept of Endocrinology, Brooklyn,  New York,  11203,  United States
      Children's Hospital of Buffalo/Kaledia Health Diabetes Center, Buffalo,  New York,  16222,  United States
      Montefioe Medical Center - DIV / c/o BRANY, Bronx,  New York,  11021,  United States
      Winthrop University Hospital, Clinical Trials Center, Mineola,  New York,  11502,  United States
North Carolina
      East Carolina University School of Medicine Dept of Pediatrics, Greenville,  North Carolina,  27858,  United States
Ohio
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308,  United States
      Forum Health/Western Reserve/TOD Children's Hospital, Youngstown,  Ohio,  44501,  United States
      Metro Health Medical Center, Cleveland,  Ohio,  44109-1998,  United States
      The Cleveland Clinic Children's Hospital/Dept of Pediatrics, Cleveland,  Ohio,  44195,  United States
South Carolina
      Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology, Greenville,  South Carolina,  29615,  United States
Tennessee
      Lebonheur Children's Medical Center, Memphis,  Tennessee,  38106,  United States
Texas
      Diabetes & Glandular Disease Clinic, San Antonio,  Texas,  78229,  United States
      S.A.M. Clinical Research Center, San Antonio,  Texas,  78229,  United States
      South Texas Applied Research, Corpus Christi,  Texas,  78411,  United States
      Driscoll Children's Hospital/Division of Medical Education/William Riley, Corpus Christi,  Texas,  78466-6530,  United States
      Wilford Hall USAF Medical Center, Lackland AFB,  Texas,  78236-5300,  United States
      Tri Quest Research Inc, Houston,  Texas,  77036,  United States
      Lance Sloan, MD, Lufkin,  Texas,  75901,  United States
Virginia
      Monarch Research Associates, Norfolk,  Virginia,  23510,  United States

Study ID Numbers:  CV138-059
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  May 3, 2002
ClinicalTrials.gov Identifier:  NCT00035542
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08