Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00035542
A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.
A Phase 3 study testing Glucovance (metformin HCl/glyburide), metformin HCl and glyburide in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Bristol-Myers Squibb at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Glucovance (metformin HCl/glyburide), metformin HCl and glyburide
- How many people
- Not given
- Where
- 50 sitesUnited States
- Study dates
- Dec 2001to Oct 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- No healthy volunteers
- Child
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%
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
University of Hawaii/Diabetes Research Group
‘Ewa Beach, Hawaii, 96706
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Southeastern Endocrine and Diabetes
Atlanta, Georgia, 33028
Hazan, Lydie
Beverly Hills, California, 90211
Childrens's Health System/Dept of PED/Diabetes/Endoncrinology
Birmingham, Alabama, 35233
Joslin Diabetes Center
Boston, Massachusetts, 02215
SUNY Downstate Medical Center / Dept of Endocrinology
Brooklyn, New York, 11203
Children's Hospital of Buffalo/Kaledia Health Diabetes Center
Buffalo, New York, 16222
St. James Diabetes Center
Chicago Heights, Illinois, 60411
Metro Health Medical Center
Cleveland, Ohio, 44109-1998
The Cleveland Clinic Children's Hospital/Dept of Pediatrics
Cleveland, Ohio, 44195
South Texas Applied Research
Corpus Christi, Texas, 78411
Driscoll Children's Hospital/Division of Medical Education/William Riley
Corpus Christi, Texas, 78466-6530
Children's Hospital
Denver, Colorado, 80218
Raymond Blank Children's Hospital
Des Moines, Iowa, 50309
Bay East Endocrinologists
Easton, Maryland, 21601
Bautista Research & Medical Center
Fresno, California, 93721
East Carolina University School of Medicine Dept of Pediatrics
Greenville, North Carolina, 27858
Greenville Hospital System/Mountain View Clinical Research/Div of Pediatric Endocrinology
Greenville, South Carolina, 29615
Center for Health Management
Gulfport, Mississippi, 39501
Hackensack Medical Center
Hackensack, New Jersey, 07601
Diabetes, Endocrine & Nutrition Core Physicians
Hampton, New Hampshire, 03842
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Tri Quest Research Inc
Houston, Texas, 77036
Endocrine & Diabetes Center
Jersey City, New Jersey, 07306
Health Care Link, Inc
La Jolla, California, 92037
Wilford Hall USAF Medical Center
Lackland Air Force Base, Texas, 78236-5300
Neufeld Medical Group
Los Angeles, California, 90048
National Institute Of Clinical Research
Los Angeles, California, 90806
Louisville Metabolic & Athersclerosis Research Center/Advanced Cardiovascular Institute
Louisville, Kentucky, 40217
Lance Sloan, MD
Lufkin, Texas, 75901
Lebonheur Children's Medical Center
Memphis, Tennessee, 38106
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, 11502
St Luke's Roosevelt Hospital/Westside Pediatrics Assoc/Clinical Pharmacology Program
New York, New York, 10023
Monarch Research Associates
Norfolk, Virginia, 23510
Lutheran General Children's Hospital
Park Ridge, Illinois, 60068
Pasadena Pediatric Endocrinology Diabetes
Pasadena, California, 91105
Vassar Brothers Hospital
Poughkeepsie, New York, 12603
A.R.I. Clinical Trials
Redondo Beach, California, 90277
University of Rochester/Dpt Pediatrics, S.M.H.
Rochester, New York, 14642
Sutter Institute For Medical Research
Sacramento, California, 95816
Diabetes & Glandular Disease Clinic
San Antonio, Texas, 78229
S.A.M. Clinical Research Center
San Antonio, Texas, 78229
Medex Healthcare Research
St Louis, Missouri, 63108
JM Clinical Trials Inc
Swansea, Massachusetts, 02777
EDU Practice Pediatric Endocrinology
Tallahassee, Florida, 32308
Montefioe Medical Center - DIV / c/o BRANY
The Bronx, New York, 11021
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Forum Health/Western Reserve/TOD Children's Hospital
Youngstown, Ohio, 44501
About this study
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.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Glucovance (metformin HCl/glyburide), metformin HCl, glyburide
- Keywords
- Diabetes Mellitus, Type II
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucovance (metformin HCl/glyburide)Drug
metformin HClDrug
glyburideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startDec 2001
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035542
- Sponsor's protocol ID
- CV138-059
- Status last verified
- Apr 2011
- First submitted
- 3 May 2002
- Last updated
- 15 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00035542
- Acronym / sponsor ID
- CV138-059
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Diabetes Mellitus, Type II
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 6 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucovance (metformin HCl/glyburide) | Drug | – |
| metformin HCl | Drug | – |
| glyburide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glucovance (metformin HCl/glyburide), metformin HCl and glyburide in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Bristol-Myers Squibb at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.