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

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.