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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 is a Phase 3 study that was terminated before completion, run by Wockhardt. The registered enrollment target is 134 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01308437
The ClinicalTrials.gov registry entry for NCT01308437 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Wosulin (N or 70/30 with R) is the first listed.
NCT01308437 reports 0 study locations.
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.
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