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NCT00837759 · ClinicalTrials.gov registry record · Phase 2
Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT00837759: Clinical Trial Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00837759 is a Phase 2 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00837759, a Phase 2 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: * Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death. * Insulin injections currently are the best method for controlling blood sugar in individuals with T1D. However, animal studies have shown that the drugs sitagliptin and lansoprazole can help reverse beta cell damage or develop new beta cells. In addition, Diamyd has been shown to weaken the immune process that attacks pancreatic beta cells. Objectives: * To find out whether a combination treatment of sitagliptin, lansoprazole, and Diamyd will help maintain functioning beta cells and/or cause new beta cells to form. * To determine how the drug combination affects insulin doses and blood sugar control. * To determine whether the drug combination affects the immune response involved in T1D.
Interventions
- DRUG Sitagliptin
- DRUG Insulin
- DRUG Lansoprazole
- BIOLOGICAL Diamyd
- DRUG GAD65 (Diamyd)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
Why NCT00837759 stopped before completion
NCT00837759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Sitagliptin is the first listed.
NCT00837759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00837759 about?
NCT00837759 is a clinical study titled "Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes". Background: * Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death. * Insulin injections currently are the best method for controlling blood sugar in individuals with T1D. However, animal studies have shown that t...
What is the current status of trial NCT00837759?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2009-02. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00837759?
The interventions under investigation include: Sitagliptin (DRUG), Insulin (DRUG), Lansoprazole (DRUG), Diamyd (BIOLOGICAL), GAD65 (Diamyd) (DRUG).
Who is sponsoring clinical trial NCT00837759?
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 NCT00837759's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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