This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.
To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
Change in HbAlc from baseline till the end of treatment period.
Time frame: 12 months
Percentage change in immunogenic response.
Evaluating antibodies titre.
Time frame: 12 months
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