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.

NCT01308437 Phase 3 TERMINATED

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

Lead sponsor	Wockhardt
Phase	Phase 3
Status	TERMINATED
Enrolment	134
Start date	2011-03
Completion	2013-04

Conditions

• Type I Diabetes

Interventions

• Wosulin (N or 70/30 with R)
• Novolin® (N or 70/30 with R)

Primary outcomes

• Change in HbAlc from baseline to 6 months of treatment between Wosulin arm and Novolin arm(as surrogate indicator of change in insulin antibodies titers between the two treatment arms). — 6 months

Countries

United States, India