Wockhardt Gets Expert Panel Nod for Phase III Study of Recombinant Insulin Aspart

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Wockhardt Limited to conduct a Phase III clinical trial of its investigational product Recombinant Insulin Aspart R, subject to key conditions.

This came after the firm presented the proposal for a Phase III clinical study titled "A prospective Randomized, Open-Label, Parallel-group, Multi-center Phase 3 Study to Compare Efficacy and Safety of Recombinant Insulin Aspart R (Manufactured by Wockhardt Limited) with NovoRapid (Manufactured by Novo Nordisk) in Adult Patients with Type 2 Diabetes Mellitus" as per Protocol Number- WOC/ASP/CT-02/25, Version 1.0 dated 23 June 2025.

Insulin aspart is a rapid-acting, man-made insulin used to manage blood sugar levels in adults and children with diabetes mellitus. It is typically injected just before or shortly after a meal to control the immediate rise in blood glucose (sugar).

It works by replacing the insulin that the body does not produce enough of or use properly, helping move sugar from the bloodstream into body tissues for energy and preventing the liver from making more sugar. Insulin aspart usually begins working within 10-20 minutes after injection, peaks in about 1 hour, and continues to work for a total of 2 to 4 hours. It is administered via subcutaneous injection (under the skin) into the abdomen, thigh, upper arm, or buttocks. Injection sites should be rotated to prevent skin changes like thickening or lumps. It can also be used in external insulin pumps.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the presented protocol, subject to the following changes:

• The study design should be changed from open label to assessor blind.
• All PI’s of the clinical trial should be Qualified Endocrinologist.
• Incidents of hypoglycemia should be recorded during the study.

Accordingly, the expert panel suggested that the revised protocol shall be submitted to CDSCO for further evaluation.