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| Sponsored by: |
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 T2DM.
| Condition | Intervention | Phase |
|
Diabetes Mellitus, Type II |
Drug: Metformin Drug: Rosiglitazone Behavioral: TODAY Lifestyle Program |
Phase III |
| MedlinePlus related topics: | Diabetes |
| Drug Information available for: | Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 750 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Metformin alone
|
Drug: Metformin
capsule, 1000 mg bid
|
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2: Experimental
Metformin + Rosiglitazone
|
Drug: Metformin
capsule, 1000 mg bid
Drug: Rosiglitazone
capsule, 4 mg bid
|
|
3: Experimental
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| Contact: Kathryn Hirst, PhD | 301-881-9260 ext 8025 | khirst@bsc.gwu.edu |
| United States, California | |||||
| Children's Hospital Los Angeles | Recruiting | ||||
| Los Angeles, California, United States, 90027 | |||||
| Contact: Karen Wexler 323-361-7645 kwexler@chla.usc.edu | |||||
| Principal Investigator: Mitchell Geffner, MD | |||||
| Sub-Investigator: Daina Dreimane, MD | |||||
| United States, Colorado | |||||
| University of Colorado Health Sciences Center, The Children's Hospital | Recruiting | ||||
| Denver, Colorado, United States, 80262 | |||||
| Contact: Nicole Celona-Jacobs 720-777-3212 celona-jacobs.nicole@TCHDEN.org | |||||
| Principal Investigator: Philip Zeitler, MD, PhD | |||||
| Sub-Investigator: Judith Glazner, PhD | |||||
| Sub-Investigator: Janine Higgins, PhD | |||||
| Sub-Investigator: Georgeanna Klingensmith, MD | |||||
| United States, Connecticut | |||||
| Yale University | Recruiting | ||||
| New Haven, Connecticut, United States, 06520 | |||||
| Contact: Cindy Guandalini 203-785-7817 cindy.guandalini@yale.edu | |||||
| Principal Investigator: Sonia Caprio, MD | |||||
| Sub-Investigator: Margaret Grey, PhD | |||||
| Sub-Investigator: William Tamborlane, MD | |||||
| United States, Massachusetts | |||||
| Massachusetts General Hospital Diabetes Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| Contact: Mary Larkin, RN 617-724-8695 mlarkin1@partners.org | |||||
| Contact: Barbara Steiner 617-724-5985 bsteiner@partners.org | |||||
| Principal Investigator: David M Nathan, MD | |||||
| Sub-Investigator: Lynne Levitsky, MD | |||||
| Sub-Investigator: Linda Delahanty | |||||
| Sub-Investigator: Benjamin Nwosu, MD | |||||
| Sub-Investigator: Soja Park-Bennett, MD | |||||
| Joslin Diabetes Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02215 | |||||
| Contact: Maureen Malloy 617-735-1919 ext 4461 maureen.malloy@joslin.harvard.edu | |||||
| Principal Investigator: Lori Laffel, MD | |||||
| United States, Missouri | |||||
| Washington University Department of Pediatrics | Recruiting | ||||
| St. Louis, Missouri, United States, 63110 | |||||
| Contact: Tracy Jones 314-286-1165 jones_t@kids.wustl.edu | |||||
| Principal Investigator: Neil H White, MD, CDE | |||||
| Sub-Investigator: Denise Wilfley, PhD | |||||
| Saint Louis University Health Sciences Center | Recruiting | ||||
| St Louis, Missouri, United States, 63104 | |||||
| Contact: Theresa Whelan 314-577-5611 whelantm@slu.edu | |||||
| Principal Investigator: Sherida Tollefsen, MD | |||||
| United States, New York | |||||
| State University of New York Upstate Medical University | Recruiting | ||||
| Syracuse, New York, United States, 13210 | |||||
| Contact: Kelly Duncan 315-464-3878 duncank@upstate.edu | |||||
| Principal Investigator: Ruth Weinstock, MD | |||||
| Sub-Investigator: Suzanne Meyer, RN, CDE | |||||
| Sub-Investigator: Ron Saletsky, PhD | |||||
| Sub-Investigator: Paula Trief, PhD | |||||
| Sub-Investigator: Jill Kanaley | |||||
| Columbia University Medical Center | Recruiting | ||||
| New York City, New York, United States, 10032 | |||||
| Contact: Pat Kringas 212-851-5489 mpk40@columbia.edu | |||||
| Principal Investigator: Robin Goland, MD | |||||
| Sub-Investigator: Natasha Leibel, MD | |||||
| United States, Ohio | |||||
| Case Western Reserve | Recruiting | ||||
| Cleveland, Ohio, United States, 44106 | |||||
| Contact: Paul McGuigan 216-368-1833 paul.mcguigan@case.edu | |||||
| Principal Investigator: Leona Cuttler, MD | |||||
| United States, Oklahoma | |||||
| University of Oklahoma | Recruiting | ||||
| Oklahoma City, Oklahoma, United States, 93104 | |||||
| Contact: Jill Schanuel 405-271-2228 Jill-schanuel@ouhsc.edu | |||||
| Principal Investigator: Kenneth Copeland, MD | |||||
| Sub-Investigator: Ryan Brown, MD | |||||
| United States, Pennsylvania | |||||
| Children's Hospital of Pittsburgh | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Contact: Kristin Porter, RN, BSN 412-692-5928 Kristin.Porter@chp.edu | |||||
| Principal Investigator: Silva Arslanian, MD | |||||
| Sub-Investigator: Andrea Kriska, PhD | |||||
| Sub-Investigator: Marsha Marcus, PhD | |||||
| Sub-Investigator: Thomas Songer, PhD | |||||
| Sub-Investigator: Ingrid Libman, MD | |||||
| Sub-Investigator: Elizabeth Venditti, PhD | |||||
| Children's Hospital of Philadelphia | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| Contact: Cathy Carchidi, RN, MS, CDE 267-426-5492 carchidi@email.chop.edu | |||||
| Contact: Beth Schwartzman 267-426-5718 schwartzmann@email.chop.edu | |||||
| Principal Investigator: Lorraine Katz, MD | |||||
| Sub-Investigator: Robert Berkowitz, MD | |||||
| Sub-Investigator: Terri Lipman, PhD | |||||
| Sub-Investigator: Steven Willi, MD | |||||
| Sub-Investigator: Sheela Magge, MD | |||||
| United States, Texas | |||||
| University of Texas Health Science Center at San Antonio | Recruiting | ||||
| San Antonio, Texas, United States, 78229 | |||||
| Contact: Rose Ann Barajas 210-562-5227 barajasr@uthscsa.edu | |||||
| Principal Investigator: Jane Lynch, MD | |||||
| Sub-Investigator: Dan Hale, MD | |||||
| Sub-Investigator: Guadalupe A Rupert, BSN | |||||
| Baylor College of Medicine | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Contact: Sue McGirk 832-822-3063 tmcgirk@bcm.tmc.edu | |||||
| Principal Investigator: Morey Haymond, MD | |||||
| Sub-Investigator: Barbara Anderson, PhD | |||||
| Sub-Investigator: Patrick Brosnan, MD | |||||
| Sub-Investigator: Siripoom McKay, MD | |||||
| Principal Investigator: | Phil Zeitler, MD, PhD | University of Colorado Health Science Center |
| Study Chair: | Francine Kaufman, MD | Children's Hospital Los Angeles |
| Principal Investigator: | Kathryn Hirst, PhD | George Washington University |
More Information
Study public website 
  |
|
The TODAY Study Group; Zeitler P, Epstein L, Grey M, Hirst K, Kaufman F, Tamborlane W, Wilfley D. Treatment options for type 2 diabetes in adolescents and youth: a study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes. Pediatr Diabetes. 2007 Apr;8(2):74-87.
  |
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Songer T, Glazner J, Coombs L, Cuttler L, Daniel M, Estrada S, Klingensmith G, Kriska A, Laffel L, Zhang P, for the TODAY Study Group. Examining the economic costs related to lifestyle and pharmacological inerventions in youth with type 2 diabetes. Expert Rev Pharmacoeconomics Outcomes Res, 6(3):315-324, 2006.
  |
| Responsible Party: | George Washington University Biostatistics Center ( Kathryn Hirst/Coordinating Center Principal Investigator ) |
| Study ID Numbers: | DK61230-TODAY, DK61230 |
| First Received: | April 8, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00081328 |
| Health Authority: | United States: Food and Drug Administration |
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