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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00081328 |
Purpose
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has sponsored a consortium of investigators to conduct a clinical treatment trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY).
The primary objective of the TODAY trial is to compare the efficacy of three treatment arms on time to treatment failure based on glycemic control. The secondary aims are to:
The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and (3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). The study recruits patients over a three-year period and follows patients for a minimum of two years. Patients are randomized within two years of the diagnosis of T2D.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type II |
Drug: Metformin Drug: Rosiglitazone Behavioral: TODAY Lifestyle Program |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial |
| Enrollment: | 699 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Metformin alone
|
Drug: Metformin
capsule, 1000 mg bid
|
|
Experimental: 2
Metformin + Rosiglitazone
|
Drug: Metformin
capsule, 1000 mg bid
Drug: Rosiglitazone
capsule, 4 mg bid
|
|
Experimental: 3
Metformin + TODAY Lifestyle Program
|
Drug: Metformin
capsule, 1000 mg bid
Behavioral: TODAY Lifestyle Program
a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study
|
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria (during Screening and Run-in period):
Exclusion Criteria (during Screening and Run-in period):
Inclusion Criteria (post Run-in and Randomization):
Exclusion Criteria (post Run-in and Randomization):
Contacts and Locations| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center, The Children's Hospital | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Maryland | |
| George Washington University Biostatistics Center | |
| Rockville, Maryland, United States, 20852 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Diabetes Center | |
| Boston, Massachusetts, United States, 02114 | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Saint Louis University Health Sciences Center | |
| St Louis, Missouri, United States, 63104 | |
| Washington University Department of Pediatrics | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York City, New York, United States, 10032 | |
| State University of New York Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Case Western Reserve | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oklahoma | |
| University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 93104 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | Phil Zeitler, MD, PhD | University of Colorado, Denver |
| Principal Investigator: | Kathryn Hirst, PhD | George Washington University |
More Information
| Responsible Party: | Kathryn Hirst/Coordinating Center Principal Investigator, George Washington University Biostatistics Center |
| ClinicalTrials.gov Identifier: | NCT00081328 History of Changes |
| Other Study ID Numbers: | IND - DK61230-TODAY, DK61230 |
| Study First Received: | April 8, 2004 |
| Last Updated: | May 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Rosiglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |