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NCT00900146 · ClinicalTrials.gov registry record · Phase 2
Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients
A Phase 2 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 2
- Development phase
- 556
- Enrollment target
NCT00900146: Clinical Trial Phase 2 study, sponsored by Novartis.
NCT00900146 is a Phase 2 study that was terminated before completion, run by Novartis. The registered enrollment target is 556 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (318% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00900146, a Phase 2 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 556 participants
- Enrollment target
Study Summary
This was a four month dose ranging study followed by a 24 to 48 month extension at the selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1, beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus (T2DM) already treated on maximum dose metformin.
Primary Outcome
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
Why NCT00900146 stopped before completion
NCT00900146 is an interventional study that assigns participants to a tested intervention. The registered 556 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (318% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00900146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00900146 about?
NCT00900146 is a clinical study titled "Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients". This was a four month dose ranging study followed by a 24 to 48 month extension at the selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1, beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus (T2DM) already treated on maxim...
What is the current status of trial NCT00900146?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 556 participants. The study started on 2009-04. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00900146?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Canakinumab (DRUG).
Who is sponsoring clinical trial NCT00900146?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00900146's enrollment target sits among peer trials
556 60th of 2000 higher than 1,941 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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