NCT01308437

Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

An Open Label,Randomized,Comparison of the Immunogenicity and Safety of Wockhardt's Human Insulin Basal Bolus Regimen With the Novo Nordisk's Yeast Based Human Insulin Basal Bolus Regimens, Marketed in United States, in Type 1 Diabetics.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-03-04
• Last updated: 2023-06-23

Locations

25 sites across 2 countries: United States, India