Continue CT with 30 ongoing Indian subjects: CDSCO panel tells Novo-Nordisk on Insulin Icodec
New Delhi: Based on the safety data of 30 Indian subjects in the global clinical trial of Insulin Icodec, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Novo Nordisk for the continuation of the trial of the antidiabetic drug Insulin Icodec with already 30 ongoing Indian subjects.
This came after the drug major Novo Nordisk presented the safety data of 30 Indian subjects in compliance with clinical trial NOC (No Objection Certificate) condition no. 1. – "The firm should submit safety data of initial 30 subjects from India for review by CDSCO for further continuation of the trial."
Insulin icodec is a long-acting basal insulin analogue, intended for once-weekly treatment, being developed by Novo Nordisk, for the treatment of type 1 and type 2 diabetes mellitus. The product has a terminal half-life of approximately 196 hours. Clinical development is underway in several countries.
Insulin icodec works after subcutaneous injection and absorption into the circulation, Icodec monomers bind to albumin to form an essentially inactive depot, from which icodec molecules slowly reach insulin receptors at target tissues to stimulate glucose lowering. Insulin icodec once-weekly doses correspond to 0.29, 0.48, and 0.57 U/kg/day, anticipating equipotency to once-daily basal insulin.
At the recent SEC meeting for endocrinology and metabolism held on February 16 and 17, 2023, the expert panel reviewed the safety data presented by the drug major Novo Nordisk on 30 Indian subjects.
Furthermore, Novo Nordisk informed that global enrollment is over, therefore further no more subjects will be enrolled from India in the study.
Accordingly, after detailed deliberation, the committee recommended the continuation of the trial, which already has 30 ongoing Indian subjects.
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