Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

NCT ID: NCT01308437


Title
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.
Purpose
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).
Details
Conditions
Type I Diabetes
Keywords
Source
Wockhardt
Sponsors
Wockhardt
Status
Terminated
Acronym
Last Updated
20 Aug 2013
URL
Official Link
Locations
India, United States