Wockhardt gets CDSCO Panel nod to study Biphasic insulin aspart
New Delhi: Reviewing the protocol presented by the drug major Wockhardt, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved conducting the clinical trial titled “A randomized, single centre, double blind, two-period, crossover glucose clamp study to test for bioequivalence between two recombinant human insulin analogues – Wockhardt’s biphasic insulin aspart injection (30/70) and novomix30, in healthy subjects.”
This came after the firm presented the clinical trial protocol titled “A randomized, single centre, double-blind, two-period, crossover glucose clamp study to test for bioequivalence between two recombinant human insulin analogues – Wockhardt’s biphasic insulin aspart injection (30/70) and novomix 30, in healthy subjects.” vide Protocol No. W-ASP (B)-104; Version No.01 dated 03.11.2023.
Biphasic insulin aspart more effectively reduces post-prandial glucose compared to other biphasic insulins and basal insulins. Compared to biphasic insulin aspart, fasting glucose levels are lower with NPH, similar with glargine, and similar or lower with biphasic human insulin.
Insulin aspart regulates the metabolism of glucose. It promotes storage and inhibits the breakdown of glucose, fat, and amino acids. Insulin lowers blood glucose by increasing peripheral glucose uptake, particularly in the skeletal muscle and fat.
At the recent SEC meeting for Endocrinology and Metabolism held on the 13th and 14th of February 2023, the expert panel reviewed the clinical trial protocol titled “A randomized, single centre, double-blind, two-period, crossover glucose clamp study to test for bioequivalence between two recombinant human insulin analogues – Wockhardt’s biphasic insulin aspart injection (30/70) and novomix®30, in healthy subjects.”
After detailed deliberation, the committee recommended to conduct the clinical trial as per the protocol presented by the firm.
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