Present revised Phase III CT protocol : CDSCO Tells Hetero Lab on Antidiabetic FDC Drug

This came after the firm presented its proposal before the committee along with BE protocol and Phase III CT protocol of the FDC Sitagliptin phosphate monohydrate plus Metformin HCl plus Voglibose(50mg/ 50mg+500mg/500mg +0.2mg/0.3mg) tablets.

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.

Voglibose belongs to a class of competitive α glucosisade inhibitors (α-GIs). The anti-hypoglycaemic action of voglibose results from a reversible inhibition of membrane-bound intestines α glycosidase hydrolyze enzymes which hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine.

At the recent SEC meeting for the Endocrinology & Metabolism held on the 16th & 17th of February 2023, the expert panel reviewed the proposal presented by the drug maker Hetero Labs along with the BE protocol & Phase III CT protocol of the FDC Sitagliptin phosphate monohydrate plus Metformin HCl plus Voglibose(50mg/ 50mg+500mg/500mg +0.2mg/0.3mg) tablets.

The committee noted that Voglibose 0.3mg is not approved.

After detailed deliberation, the committee recommended for grant of permission to conduct the BE study for FDC of Sitagliptin phosphate monohydrate 50mg + Metformin HCl 500mg + Voglibose 0.2mg tablet.

In accordance with the above, the expert panel suggested the firm to present the revised Phase III CT protocol before the committee.