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NCT01364350 · ClinicalTrials.gov registry record
TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study
A clinical trial of Diabetes Mellitus Type 2 in Obese, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 550
- Enrollment target
- 16
- Study locations
NCT01364350: Completed study of Diabetes Mellitus Type 2 in Obese, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01364350 is a study of Diabetes Mellitus Type 2 in Obese that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 550 participants. The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364350, a study of Diabetes Mellitus Type 2 in Obese, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 550 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to continue to follow participants in the TODAY clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are analyzed and findings interpreted to develop a long-term observational protocol (phase 2). Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.
Primary Outcome
The primary objective of the first phase of TODAY2 is to begin to examine the persistence of effects of the TODAY treatment assignment on long-term glycemic control following discontinuation of randomized treatment. During this period, results of TODAY are produced and used to define additional outcomes for the second phase of TODAY2.
Conditions Studied
Interventions
- OTHER standard of care in general clinical practice
Study Locations (16)
Massachusetts
- Massachusetts General Hospital Diabetes Center - Boston
- Joslin Diabetes Center - Boston
Missouri
- Saint Louis University - St Louis
- Washington University - St Louis
New York
- Columbia University Medical Center - New York
- State University of New York Upstate Medical University - Syracuse
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Texas
- Baylor College of Medicine - Houston
- University of Texas Health Science Center at San Antonio - San Antonio
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- University of Colorado Denver - Denver
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-02 |
What the finished NCT01364350 record still lists
NCT01364350 is an observational study that tracks outcomes without assigning an intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Diabetes Mellitus Type 2 in Obese appearing as the primary indexed condition, and to 1 intervention - of which standard of care in general clinical practice is the first listed.
NCT01364350 lists 16 locations in 11 states (Massachusetts, Missouri, New York).
Frequently Asked Questions
What is clinical trial NCT01364350 about?
NCT01364350 is a clinical study titled "TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study". The purpose of this study is to continue to follow participants in the TODAY clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are analyzed and findings ...
What is the current status of trial NCT01364350?
This trial is currently completed. The enrollment target is 550 participants. The study started on 2011-03. Estimated completion is 2014-02.
What conditions does trial NCT01364350 study?
This clinical trial studies the following conditions: Diabetes Mellitus Type 2 in Obese.
What interventions are being tested in trial NCT01364350?
The interventions under investigation include: standard of care in general clinical practice (OTHER).
Who is sponsoring clinical trial NCT01364350?
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.
Where is trial NCT01364350 being conducted?
This trial has 16 study locations across California, Colorado, Connecticut, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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