Trial record 1 of 1 for:    nct00081328
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Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathryn Hirst, George Washington University
ClinicalTrials.gov Identifier:
NCT00081328
First received: April 8, 2004
Last updated: December 8, 2014
Last verified: December 2014
Results First Received: September 26, 2014  
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
Condition: Diabetes Mellitus, Type II
Interventions: Drug: Metformin
Drug: Rosiglitazone
Behavioral: Lifestyle Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from July 2004 to February 2009. Participants were recruited from the patient populations of pediatric endocrine clinics at the participating study clinical centers, including satellite clinics. Posters announced the study. Study staff approached youth and their families during medical visits.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, eligible subjects entered a 2-6 month run-in period, with goals of weaning from non-study diabetes medications, tolerating metformin at 1000 mg bid but no less than 500 mg bid, attaining glycemic control on metformin alone, mastering standard diabetes education, and adhering to study medication and visit attendance.

Reporting Groups
  Description
1 Metformin Alone

Metformin alone

Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets

2 Metformin + Rosliglitazone

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets

3 Metformin + Lifestyle Program

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets

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


Participant Flow:   Overall Study
    1 Metformin Alone     2 Metformin + Rosliglitazone     3 Metformin + Lifestyle Program  
STARTED     232     233     234  
COMPLETED     232     233     234  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Age 10–17 years with T2D according to American Diabetes Association criteria for less than 2 years, body mass index (BMI) >=85th percentile, negative diabetes autoantibodies, fasting c-peptide >0.6 ng/mL, and an adult caregiver willing to actively support study participation.

Reporting Groups
  Description
1 Metformin Alone

Metformin alone

Metformin: capsule, 1000 mg bid

2 Metformin + Rosiglitazone

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

3 Metformin + Lifestyle Program

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

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

Total Total of all reporting groups

Baseline Measures
    1 Metformin Alone     2 Metformin + Rosiglitazone     3 Metformin + Lifestyle Program     Total  
Number of Participants  
[units: participants]
  232     233     234     699  
Age  
[units: years]
Mean (Standard Deviation)
  14.1  (1.9)     14.1  (2.1)     13.8  (2.0)     14.0  (2.0)  
Gender  
[units: participants]
       
Female     146     152     154     452  
Male     86     81     80     247  
Race/Ethnicity, Customized  
[units: participants]
       
American Indian     12     16     13     41  
Black Non-Hispanic     77     64     86     227  
Hispanic     91     101     86     278  
White Non-Hispanic     49     47     46     142  
Asian Non-Hispanic     3     5     3     11  
Region of Enrollment  
[units: participants]
       
United States     232     233     234     699  
Body mass index z-score  
[units: z-score]
Mean (Standard Deviation)
  2.27  (0.45)     2.22  (0.49)     2.18  (0.46)     2.23  (0.47)  
Percent overweight  
[units: 100% X (BMI-50th %ile)/50th %ile]
Mean (Standard Deviation)
  82.1  (38.3)     79.1  (38.1)     75.6  (35.3)     78.9  (37.3)  
Duration of diabetes  
[units: months]
Mean (Standard Deviation)
  7.8  (6.0)     8.0  (5.7)     7.6  (5.8)     7.8  (5.8)  
Total annual household income  
[units: participants]
       
< $25,000     81     86     92     259  
$25,000-49,999     83     61     66     210  
>=$50,000     44     58     53     155  
unknown     24     28     23     75  
Highest household education level  
[units: participants]
       
Less than high school     60     60     62     182  
High school, GED, business or technical     57     49     66     172  
College no degree     77     78     63     218  
Graduate degree     35     41     38     114  
Unknown     3     5     5     13  
Tanner stage by physical examination [1]
[units: participants]
       
4 or 5     209     207     204     620  
1, 2, or 3     23     26     30     79  
Nuclear family history of diabetes  
[units: participants]
       
No     97     93     86     276  
Yes     131     133     143     407  
Unknown     4     7     5     16  
Nuclear family + grandparents history of diabetes  
[units: participants]
       
No     17     26     29     72  
Yes     211     200     200     611  
Unknown     4     7     5     16  
Insulin sensitivity (inverse of fasting insulin from OGTT)  
[units: mL/uU]
Median (Inter-Quartile Range)
  .036   (.025 to .050)     .040   (.028 to .064)     .040   (.027 to .067)     .039   (.027 to .060)  
Insulinogenic index from OGTT  
[units: uU/mL divided by mg/dL]
Median (Inter-Quartile Range)
  1.02   (.47 to 1.98)     .92   (.47 to 1.58)     .87   (.47 to 1.89)     .93   (.47 to 1.85)  
Body mass index (BMI)  
[units: kg per m squared]
Mean (Standard Deviation)
  35.8  (8.1)     35.0  (7.7)     34.1  (7.1)     34.9  (7.6)  
Waist circumference  
[units: cm]
Mean (Standard Deviation)
  110.4  (16.6)     109.0  (17.0)     106.6  (16.2)     108.6  (16.7)  
Fat mass from DXA  
[units: kg]
Mean (Standard Deviation)
  33.7  (9.9)     33.5  (10.2)     32.6  (9.8)     33.3  (10.0)  
Bone density from DXA  
[units: g per cm squared]
Mean (Standard Deviation)
  1.09  (.12)     1.10  (.13)     1.08  (.12)     1.09  (.13)  
[1] Tanner stage is a standard 5-point scale of pubertal maturity from 1 (pre-pubertal) to 5 (post-pubertal).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Failure (Loss of Glycemic Control)   [ Time Frame: 6 months ]

2.  Secondary:   Insulin Sensitivity   [ Time Frame: 24 months ]

3.  Secondary:   Safety   [ Time Frame: Reported as occurred during study follow-up. ]

4.  Secondary:   Insulin Secretion   [ Time Frame: 24 months ]

5.  Secondary:   Body Composition -- BMI   [ Time Frame: 24 months ]

6.  Secondary:   Body Composition -- Waist Circumference   [ Time Frame: 24 months ]

7.  Secondary:   Body Composition -- Bone Density   [ Time Frame: 24 months ]

8.  Secondary:   Body Composition -- Fat Mass   [ Time Frame: 24 months ]

9.  Secondary:   Comorbidity -- Hypertension   [ Time Frame: Data collected at baseline and during follow-up. ]

10.  Secondary:   Comorbidity -- LDL Dyslipidemia   [ Time Frame: Data collected at baseline and during follow-up. ]

11.  Secondary:   Comorbidity -- Triglycerides Dyslipidemia   [ Time Frame: Data collected at baseline and during follow-up. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Kathryn Hirst, Coordinating Center PI
Organization: TODAY Coordinating Center at George Washington University Biostatistics Center
phone: 301-881-9260 ext 8025
e-mail: khirst@bsc.gwu.edu


Publications of Results:

Other Publications:
Publications automatically indexed to this study:


Responsible Party: Kathryn Hirst, George Washington University
ClinicalTrials.gov Identifier: NCT00081328     History of Changes
Other Study ID Numbers: IND - DK61230-TODAY
Study First Received: April 8, 2004
Results First Received: September 26, 2014
Last Updated: December 8, 2014
Health Authority: United States: Food and Drug Administration