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Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

NCT01308437 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-06-23

No results posted yet for this 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).

Conditions

  • Type I Diabetes

Interventions

BIOLOGICAL

Wosulin (N or 70/30 with R)

Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously.

BIOLOGICAL

Novolin® (N or 70/30 with R)

Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously.

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Ashima Bhatia, M.D. · Wockhardt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308437 on ClinicalTrials.gov