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Clinical Trials associated with Insulin human biosimilar(Wockhardt Ltd.)An Open Label, Randomized, comparison of the Immunogenicity and Safety of Wockhardts Human Insulin Basal Bolus Regimen {Intensified Conventional Insulin Therapy with Soluble Insulin and Isophane Insulin (Wosulin R, Wosulin N and Wosulin 70/30)} with the Novo Nordisk?s yeast based Human Insulin Basal Bolus Regimens, marketed in United States (Novolin® R, Novolin® N and Novolin® 70/30) 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.
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:
Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below).
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).
Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.
100 Clinical Results associated with Insulin human biosimilar(Wockhardt Ltd.)
100 Translational Medicine associated with Insulin human biosimilar(Wockhardt Ltd.)
100 Patents (Medical) associated with Insulin human biosimilar(Wockhardt Ltd.)
100 Deals associated with Insulin human biosimilar(Wockhardt Ltd.)