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NCT00081328 · ClinicalTrials.gov registry record · Phase 3
Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 699
- Enrollment target
NCT00081328: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00081328 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 699 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081328, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 699 participants
- Enrollment target
Study Summary
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 (T2D) 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 T2D.
Primary Outcome
Defined as A1c persistently \>=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)
Interventions
- DRUG Metformin
- DRUG Rosiglitazone
- BEHAVIORAL Lifestyle Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 699 participants |
| Start Date | 2004-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00081328 record still lists
NCT00081328 is an interventional study that assigns participants to a tested intervention. The registered 699 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT00081328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00081328 about?
NCT00081328 is a clinical study titled "Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)". 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...
What is the current status of trial NCT00081328?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 699 participants. The study started on 2004-05. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00081328?
The interventions under investigation include: Metformin (DRUG), Rosiglitazone (DRUG), Lifestyle Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT00081328?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00081328's enrollment target sits among peer trials
699 516th of 2000 higher than 1,485 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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