Glenmark gets CDSCO panel nod for Phase 4 study of anti-diabetic FDC drug
New Delhi: In line with the drug major Glenmark Pharmaceutical's revised Phase IV clinical trial protocol for anti-diabetic fixed dose combination drug, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to conduct the proposed Phase IV clinical trial of anti-diabetic fixed dose combination containing Remogliflozin etabonate 100mg/100mg plus Vildagliptin 50mg/50mg plus Metformin Hydrochloride 500mg/1000mg tablet.
This came after the firm presented the proposed revised Phase IV clinical trial protocol of the combination drug Remogliflozinetabonate 100mg/100mg plus Vildagliptin 50mg/50mg plus Metformin Hydrochloride 500mg/1000mg tablet before the committee.
Remogliflozin etabonate has been used in trials studying the treatment and basic science of Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2. Remogliflozin Etabonate is an orally available prodrug of remogliflozin, a benzylpyrazole glucoside-based inhibitor of renal sodium-glucose co-transporter subtype 2 (SGLT2) with antihyperglycemic activity. Upon administration and absorption, the inactive prodrug is converted to its active form remogliflozin and acts selectively on the sodium-glucose co-transporter subtype 2 (SGLT2).
Vildagliptin is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. It is used to manage type II diabetes mellitus, where GLP-1 secretion and insulinotropic effects are impaired. By inhibiting DPP-4, vildagliptin prevents the degradation of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are incretin hormones that promote insulin secretion and regulate blood glucose levels. Elevated levels of GLP-1 and GIP consequently results in improved glycemic control.
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. 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
A fixed-dose combination of Remogliflozin etabonate, Vildagliptin, and Metformin is recommended for Type 2 diabetes management. The fixed drug combination comprises of 100 mg of Remogliflozin ,50 mg of Vildagliptin ,and 50 mg or 100 mg of Metformin .
This fixed drug combination has to be taken twice daily for the suggested benefits of a decrease in glycemia.
Glenmark Pharmaceuticals is the first and foremost company to introduce this fixed drug combination in the world. DCGI has approved the fixed drug combination for selling and production. This fixed drug combination has been introduced in the market under two brand names, Remo MV and Remozen MV
At the latest SEC meeting for Endocrinology & Metabolism, the committee thoroughly examined the proposed protocol of the combination drug Remogliflozinetabonate 100mg/100mg plus Vildagliptin 50mg/50mg plus Metformin Hydrochloride 500mg/1000mg tablet before the committee on 18th of February.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase IV clinical trial.
