Sun Pharma Dapagliflozin, Glimepiride, Metformin FDC gets CDSCO panel nod for phase 3 trial

New Delhi: Pharmaceutical major, Sun Pharma, has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of an anti-diabetic fixed dose combination drug comprising Dapagliflozin Propanediol Monohydrate, Glimepiride, and Metformin Hydrochloride.

The approval has been granted on the condition that the patients who are already on FDC of Glimepiride 1mg + Metformin 1000mg should be included in the study and, accordingly, a revised protocol should be submitted to CDSCO for approval.

This recommendation came after the drug-maker Sun Pharma presented a proposal for Dapagliflozin Propanediol Monohydrate eq to Dapagliflozin 10mg + Glimepiride IP 1mg/2mg + Metformin Hydrochloride IP (as extended release) 1000mg tablets. The firm also presented the bioequivalence (BE) and clinical trial (CT) protocols before the committee. 

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor that is used to treat type 2 diabetes. In adults, dapagliflozin improves glycemic control by blocking glucose resorption in the proximal tubule of the nephron and causing glycosuria when used in conjunction with diet and exercise. On January 8, 2014, the FDA approved dapagliflozin.

Glimepiride belongs to the second-generation sulfonylurea (SU) drug class which is used for the management of type 2 diabetes mellitus (T2DM) to improve glycemic control. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells. Glimepiride was approved by the Food and Drug Administration (FDA) in the United States in 1995 for the treatment of T2DM.

Metformin is a popular antihyperglycemic agent that belongs to the biguanide class of drugs. It lowers blood glucose levels by reducing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is the drug of choice for obese type II diabetes patients.

The committee at its 78th SEC meeting for Endocrinology & Metabolism thoroughly examined the proposal presented by Sun Pharma.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BE study.

As regard to the Phase III clinical trial, the committee recommended that the grant of permission to conduct the proposed clinical trial with the condition that the patients who are already on FDC of Glimepiride 1mg + Metformin 1000mg be included in the study, and accordingly, a revised protocol should be submitted to CDSCO for approval.