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Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), July 2008

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:

  • compare and evaluate the safety of the three treatment arms;
  • compare the effects of the three treatments on the pathophysiology of type 2 diabetes mellitus (T2DM) with regards to beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes;
  • evaluate the influence of individual and family behaviors on treatment response; and
  • compare the relative cost effectiveness of the three treatment arms.

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   

U.S. FDA Resources

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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Treatment failure (loss of glycemic control) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
  • Insulin sensitivity and secretion [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Nutrition/dietary intake [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Physical fitness [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Microvascular complications [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Quality of life and psychological measures [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Resource utilization and cost [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Gene expression [ Time Frame: one time collection of genetic material ] [ Designated as safety issue: No ]

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
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

Criteria

Inclusion Criteria (during Screening and Run-in period):

  • Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour OGTT glucose ≥ 200 mg/dL) documented and confirmed in medical record. For patients diagnosed with diabetes during screening who have a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
  • Duration since diagnosis less than two years by date of randomization.
  • BMI ≥ 85th percentile documented at time of diagnosis or at screening.
  • Fasting C-peptide at screening (drawn at least one week after treatment for ketosis or acidosis, if applicable) > 0.6 ng/mL.
  • Absence of pancreatic autoimmunity (both GAD and ICA512 negative).
  • Age 10-17, with randomization prior to 18th birthday.
  • Signed informed consent/assent forms for the pre-randomization period.
  • A family member or adult closely involved in the daily activities of the child agrees to participate in the child's treatment.
  • Fluency in English or Spanish for both child and family member.
  • Patient and family able to fully participate in trial protocol in the opinion of the investigator.

Exclusion Criteria (during Screening and Run-in period):

  • Participating in another interventional research study protocol in the past 30 days.
  • Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
  • Patient on inhaled steroids at dose above 1000 mcg daily Flovent equivalent.
  • Patient on a course of oral steroids within the last 60 days or on oral steroids more than 20 days during the past year.
  • Patient on medication(s) that are known to affect insulin sensitivity or secretion within the last 30 days.
  • Patient on medication(s) that are known to cause weight gain within the last 30 days.
  • Patient on any weight-loss medication(s) within the last 30 days.
  • Patient on medication(s) known to affect the metabolism of study drug.
  • Inability to comprehend the lowest grade level at which lifestyle intervention materials are prepared, for both child and participating family member.
  • Females who are pregnant, planning to become pregnant within two years of enrollment, or who admit sexual activity without appropriate contraception.
  • Calculated creatinine clearance < 70 mL/min.
  • Any transaminase > 2.5 ULN. If any transaminase 1.5-2.5 times ULN, then patient must be appropriately evaluated by PCP (minimum evaluation includes ceruloplasmin level, alpha-1 antitrypsin phenotype, ANA, anti-smooth muscle antibody, anti-LKM antibody, anti-HCV, and anti-HBc total antibody not IgM, iron, and TIBC) and is eligible if all other causes for elevation are ruled out and it is presumed due only to non-alcoholic fatty liver disease (NAFLD).
  • Diabetic ketoacidosis (DKA) at any time after diagnosis unless only a single episode of DKA related to a significant medical illness.
  • Physical limitations preventing patient from being randomized to the lifestyle intervention.
  • Patient plans to leave the geographic area within one calendar year.
  • Abnormal reticulocyte count or HbA1c chromatogram at time of screening.
  • Admitted use of anabolic steroids within the past 60 days.
  • Other significant organ system illness or condition (including psychiatric or developmental disorder) that would prevent participation in the opinion of the investigator.
  • Patient participates in a formal weight-loss program.

Inclusion Criteria (post Run-in and Randomization):

  • Duration since diagnosis less than 2 years at randomization.
  • HbA1c < 8% on metformin alone.
  • Age 10-17, with randomization before patient is 18 years old.
  • Signed consent/assent forms for randomization and the post-randomization phase.
  • A family member or adult closely involved in the daily activities of the child agrees to participate in the child's treatment.
  • Fluency in English or Spanish for both child and family member.
  • Patient and family able to fully participate in trial protocol in the opinion of the investigator.

Exclusion Criteria (post Run-in and Randomization):

  • Refractory hypertension: average systolic blood pressure ≥ 150 mmHg or average diastolic blood pressure ≥ 95 mmHg despite appropriate medical therapy.
  • Refractory hyperlipidemia: total cholesterol > 300 mg/dL or LDL > 190 mg/dL or triglycerides > 800 mg/dL, despite appropriate medical therapy.
  • Refractory anemia: hematocrit < 30% or hemoglobin < 10 gm/dL despite appropriate medical therapy.
  • Patient on a thiazolidinedione (TZD) within the last 12 weeks.
  • Patient on non-study diabetes medications within the past 6 weeks.
  • Patient on inhaled steroids at dose above 1000 mcg daily Flovent equivalent.
  • Patient on a course of oral steroids within the last 60 days or on oral steroids more than 20 days during the past year.
  • Patient on medication(s) that are known to affect insulin sensitivity or secretion within the last 30 days.
  • Patient on medication(s) that are known to cause weight gain within the last 30 days.
  • Patient on any weight-loss medication(s) within the last 30 days.
  • Patient on medication(s) known to affect the metabolism of study drug.
  • Inability to comprehend the lowest grade level at which lifestyle intervention materials are prepared, for both child and participating family member, assessed by mastery of standard diabetes education program administered during run-in.
  • Inability to comply with requirements of study during run-in period.
  • Females who are pregnant, planning to become pregnant within two years of enrollment, or who admit sexual activity without appropriate contraception.
  • Calculated creatinine clearance < 70 mL/min.
  • Physical limitations preventing patient from being randomized to the lifestyle intervention.
  • Patient plans to leave the geographic area within one calendar year.
  • Admitted use of anabolic steroids within 60 days.
  • Other significant organ system illness or condition (including psychiatric or developmental disorder) that would prevent participation in the opinion of the investigator.
  • Patient participates in a formal weight loss program.
  • Episode of DKA during the run-in.30.
  • Edema at the time of randomization (a participant who experiences edema during run-in must have recovered within 2 weeks and be edema free for 1 week prior to randomization).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081328

Contacts
Contact: Kathryn Hirst, PhD     301-881-9260 ext 8025     khirst@bsc.gwu.edu    

Locations
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            

Sponsors and Collaborators

Investigators
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  This link exits the ClinicalTrials.gov site
 

Publications:
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.
 
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

Study placed in the following topic categories:
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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