A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.
Overview[ - collapse ][ - ]
| Purpose | 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 | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: Glucovance (metformin HCl/glyburide) Drug: metformin HCl Drug: glyburide |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00035542 |
| First Received | May 3, 2002 |
| Last Updated | April 7, 2011 |
| Last verified | April 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 3, 2002 |
|---|---|
| Last Updated Date | April 7, 2011 |
| Start Date | December 2001 |
| Estimated Primary Completion Date | October 2003 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes. |
|---|---|
| Official Title | Not Provided |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: Glucovance (metformin HCl/glyburide) Drug: metformin HCl Drug: glyburide |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | October 2003 |
| Estimated Primary Completion Date | October 2003 |
| 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% |
| Gender | Both |
| Ages | 9 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00035542 |
|---|---|
| Other Study ID Numbers | CV138-059 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | April 2011 |
Locations[ + expand ][ + ]
| Childrens's Health System/Dept of PED/Diabetes/Endoncrinology | Birmingham, Alabama, United States, 35233 |
|---|---|
| Advanced Clinical Therapeutics | Tucson, Arizona, United States, 85712 |
| Hazan, Lydie | Beverly Hills, California, United States, 90211 |
| Bautista Research & Medical Center | Fresno, California, United States, 93721 |
| Health Care Link, Inc | La Jolla, California, United States, 92037 |
| Neufeld Medical Group | Los Angeles, California, United States, 90048 |
| National Institute Of Clinical Research | Los Angeles, California, United States, 90806 |
| Pasadena Pediatric Endocrinology Diabetes | Pasadena, California, United States, 91105 |
| A.R.I. Clinical Trials | Redondo Beach, California, United States, 90277 |
| Sutter Institute For Medical Research | Sacramento, California, United States, 95816 |
| Children's Hospital | Denver, Colorado, United States, 80218 |
| Connecticut Children's Medical Center | Hartford, Connecticut, United States, 06106 |
| Children's National Medical Center | Washington, District of Columbia, United States, 20010 |
| EDU Practice Pediatric Endocrinology | Tallahassee, Florida, United States, 32308 |
| Southeastern Endocrine and Diabetes | Atlanta, Georgia, United States, 33028 |
| University of Hawaii/Diabetes Research Group | Ewa Beach, Hawaii, United States, 96706 |
| St. James Diabetes Center | Chicago Heights, Illinois, United States, 60411 |
| Lutheran General Children's Hospital | Park Ridge, Illinois, United States, 60068 |
| Raymond Blank Children's Hospital | Des Moines, Iowa, United States, 50309 |
| Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute | Louisville, Kentucky, United States, 40217 |
| Bay East Endocrinologists | Easton, Maryland, United States, 21601 |
| Joslin Diabetes Center | Boston, Massachusetts, United States, 02215 |
| JM Clinical Trials Inc | Swansea, Massachusetts, United States, 02777 |
| Center for Health Management | Gulfport, Mississippi, United States, 39501 |
| Medex Healthcare Research | St Louis, Missouri, United States, 63108 |
| Diabetes, Endocrine & Nutrition Core Physicians | Hampton, New Hampshire, United States, 03842 |
| Hackensack Medical Center | Hackensack, New Jersey, United States, 07601 |
| Endocrine & Diabetes Center | Jersey City, New Jersey, United States, 07306 |
| Montefioe Medical Center - DIV / c/o BRANY | Bronx, New York, United States, 11021 |
| SUNY Downstate Medical Center / Dept of Endocrinology | Brooklyn, New York, United States, 11203 |
| Children's Hospital of Buffalo/Kaledia Health Diabetes Center | Buffalo, New York, United States, 16222 |
| Winthrop University Hospital, Clinical Trials Center | Mineola, New York, United States, 11502 |
| St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program | New York, New York, United States, 10023 |
| Vassar Brothers Hospital | Poughkeepsie, New York, United States, 12603 |
| University of Rochester/Dpt Pediatrics, S.M.H. | Rochester, New York, United States, 14642 |
| East Carolina University School of Medicine Dept of Pediatrics | Greenville, North Carolina, United States, 27858 |
| Children's Hospital Medical Center of Akron | Akron, Ohio, United States, 44308 |
| Metro Health Medical Center | Cleveland, Ohio, United States, 44109-1998 |
| The Cleveland Clinic Children's Hospital/Dept of Pediatrics | Cleveland, Ohio, United States, 44195 |
| Forum Health/Western Reserve/TOD Children's Hospital | Youngstown, Ohio, United States, 44501 |
| Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology | Greenville, South Carolina, United States, 29615 |
| Lebonheur Children's Medical Center | Memphis, Tennessee, United States, 38106 |
| South Texas Applied Research | Corpus Christi, Texas, United States, 78411 |
| Driscoll Children's Hospital/Division of Medical Education/William Riley | Corpus Christi, Texas, United States, 78466-6530 |
| Tri Quest Research Inc | Houston, Texas, United States, 77036 |
| Wilford Hall USAF Medical Center | Lackland AFB, Texas, United States, 78236-5300 |
| Lance Sloan, MD | Lufkin, Texas, United States, 75901 |
| Diabetes & Glandular Disease Clinic | San Antonio, Texas, United States, 78229 |
| S.A.M. Clinical Research Center | San Antonio, Texas, United States, 78229 |
| Monarch Research Associates | Norfolk, Virginia, United States, 23510 |