This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus
To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously
Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50 The drugs would be administered subcutaneously
Change in HbA1c
Time frame: 6 months
Percentage change in the immunogenic response
Time frame: 6 months
Correlation of the immunogenicity with hypoglycemia
Time frame: 12 months
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