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

Written by Dr. Divya Colin Published On 2023-03-06T18:00:14+05:30 | Updated On 6 March 2023 12:30 PM GMT

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

New Delhi: Granting permission to conduct the bioequivalence (BE) study for antidiabetic fixed dose combination (FDC) of Sitagliptin phosphate monohydrate 50mg plus Metformin HCl 500mg plus Voglibose 0.2mg tablet., the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Hetero Labs to present the revised Phase III clinical trial protocol before the committee.

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.

Metformin Hydrochloride is the hydrochloride salt of the biguanide metformin with antihyperglycemic and potential antineoplastic activities. Metformin inhibits complex I (NADPH: ubiquinone oxidoreductase) of the mitochondrial respiratory chain, thereby increasing the cellular AMP to ATP ratio and leading to the activation of AMP-activated protein kinase (AMPK) and regulating AMPK-mediated transcription of target genes. This eventually prevents hepatic gluconeogenesis, enhances insulin sensitivity and fatty acid oxidation and ultimately leads to a decrease in glucose levels.

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.

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.