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NCT01308437 · ClinicalTrials.gov registry record · Phase 3
Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics
A Phase 3 study, sponsored by Wockhardt.
- Terminated
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT01308437: Clinical Trial Phase 3 study, sponsored by Wockhardt.
NCT01308437 is a Phase 3 study that was terminated before completion, run by Wockhardt. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01308437, a Phase 3 study, was terminated before completion, sponsored by Wockhardt.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study Summary
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics. There are two phases of the study, which are as follows: 1. Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below). 2. Phase 2 is a follow up phase only applicable to Wosulin Arm. The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately 28 weeks for the patients enrolled in the comparator arm. Two hundred and forty two patients will be enrolled considering an estimated dropout rate of 15% for a sample size of approximately 105 evaluable patients per arm. The total planned enrollment period for this study is approximately 3 months (90 days).
Interventions
- BIOLOGICAL Wosulin (N or 70/30 with R)
- BIOLOGICAL Novolin® (N or 70/30 with R)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
Why NCT01308437 stopped before completion
NCT01308437 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Wosulin (N or 70/30 with R) is the first listed.
NCT01308437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01308437 about?
NCT01308437 is a clinical study titled "Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics". This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics. There are two phases of the study, which are as foll...
What is the current status of trial NCT01308437?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2011-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01308437?
The interventions under investigation include: Wosulin (N or 70/30 with R) (BIOLOGICAL), Novolin® (N or 70/30 with R) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01308437?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01308437's enrollment target sits among peer trials
134 1585th of 2000 higher than 413 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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