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NCT00947427 · ClinicalTrials.gov registry record · Phase 2
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT00947427 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 71 participants.
The verdict
NCT00947427, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management. Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year. All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.
Interventions
- DRUG Placebo
- DRUG canakinumab (anti IL-1beta)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00947427
The ClinicalTrials.gov registry entry for NCT00947427 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00947427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00947427 about?
NCT00947427 is a clinical study titled "Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes". Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. The study is a two-arm, multicenter, randomized, double-masked, placebo-c...
What is the current status of trial NCT00947427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2010-10. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00947427?
The interventions under investigation include: Placebo (DRUG), canakinumab (anti IL-1beta) (DRUG).
Who is sponsoring clinical trial NCT00947427?
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.
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