Modify eGFR value as per standard guidelines: CDSCO Panel Tells Hetero Lab on Antidiabetic FDC Drug
New Delhi: Reviewing the drug major Hetero Lab’s revised Phase III clinical trial protocol of fixed-dose combination antidiabetic drug Sitagliptin plus Metformin plus Voglibose, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has suggested that in the exclusion criteria, estimated glomerular filtration rate (eGFR) value should be modified as per the standard guidelines.
Furthermore, the expert panel suggested the firm submit the revised Phase III clinical trial protocol along with the bioequivalence (BE) report to the committee.
This came after Hetero Lab presented its proposal along with the revised Phase III clinical trial protocol before the committee.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus.Metformin’s mechanisms of action are unique from other classes of oral antihyperglycemic drugs. Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization
Voglibose is an alpha-glucosidase inhibitor indicated in the management of postprandial blood glucose in patients with type II diabetes. Voglibose is used to reduce high post-meal glucose levels in diabetes mellitus in patients who have been using other diabetic medications. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Voglibose is an anti-diabetic medicine.
The hypoglycaemic action of voglibose results from a reversible inhibition of membrane-bound intestines α glycosidase hydrolase enzymes which hydrolize oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine.
At the recent SEC meeting endocrinology and metabolism held on 23 November 2023, the expert panel reviewed the proposal along with the revised Phase III clinical trial protocol of the antidiabetic drug Sitagliptin phosphate monohydrate plus Metformin HCl plus Voglibose film-coated tablet, presented by Hetero Lab.
After detailed deliberation, the committee recommended that in the exclusion criteria, the eGFR value should be modified as per the standard guidelines.
Accordingly, the expert panel suggested that the revised Phase III clinical trial protocol along with BE study reports should be presented before the SEC.
