Sanofi Gets CDSCO panel okay for retrospective study of Insulin Glargine

This came after Sanofi presented the protocol for conducting a retrospective study of Insulin Glargine before the committee.

A retrospective study is performed a posteriori, using the information on events that have taken place in the past. In most cases, some or most of the data has already been gathered and stored in the registry. Unlike prospective studies, a retrospective study usually does not need to follow patients into the future and often requires less time to conduct than a prospective study. In a retrospective study, different patient populations can be compared for one or several outcomes.

Insulin glargine is a long-acting insulin, used in the management of type I and type II diabetes. Insulin glargine differs from human insulin by replacing asparagine with glycine in position 21 of the A-chain and by carboxy-terminal extension of the B-chain by 2 arginine residues. The arginine amino acids shift the isoelectric point from a pH of 5.4 to 6.7, making the molecule more soluble at an acidic pH and less soluble at physiological pH. The isoelectric shift also allows for the subcutaneous injection of a clear solution. The glycine substitution prevents deamidation of the acid-sensitive asparagine at acidic pH. In the neutral subcutaneous space, higher-order aggregates form, resulting in a slow, peakless dissolution and absorption of insulin from the site of injection. It can achieve a peakless level for at least 24 hours.

Diabetes is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes from the food you eat. Insulin, a hormone made by the pancreas, helps glucose from food get into your cells to be used for energy.

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy

Type 2 diabetes is an impairment in the way the body regulates and uses sugar (glucose) as a fuel. This long-term (chronic) condition results in too much sugar circulating in the bloodstream.

At the recent SEC meeting for Endocrinology & Metabolism, held at CDSCO headquarters on March 17^th, 2022, the committee thoroughly examined the proposal presented by Sanofi Limited to conduct a retrospective study of Insulin Glargine for the treatment of diabetic type 1 & 2.

After detailed deliberation, the committee recommended the grant of approval for the study.