Submit BE study, Phase III trial protocol: CDSCO panel tells Glenmark on Metformin, Glimepiride, Lobeglitazon FDC
New Delhi: Citing the proposed fixed-dose combination (FDC) is not approved internationally, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Glenmark Pharmaceuticals to submit bioequivalence (BE) study protocol as well as Phase III clinical trial protocol of antidiabetic fixed dose combination drug, Metformin HCl IP (As extended-release form) 500mg/1000mg plus Glimepiride IP 1mg/1mg plus Lobeglitazone sulfate 0.5mg/0.5mg tablets.
This came after the drug major Glenmark Pharmaceuticals presented their proposal along with a request for BE study and Phase III clinical trial study waiver for the proposed fixed-dose combination (FDC) Metformin HCl IP (As extended-release form) 500mg/1000mg plus Glimepiride IP 1mg/1mg plus Lobeglitazone sulfate 0.5mg/0.5mg tablets.
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
Glimepiride is a sulfonylurea drug used to treat type 2 diabetes mellitus. 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.
Lobeglitazone is an antidiabetic medication from the thiazolidinedione class of drugs. It primarily functions as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells. By activating PPAR-gamma and promoting the binding of insulin at fat cells, lobeglitazone thereby has been shown to reduce blood sugar levels, lower hemoglobain A1C (HbA1C) levels, and improve lipid and liver profiles.
At the recent SEC meeting for Endocrinology and Metabolism held on 19th September 2023, the expert panel reviewed the proposal presented by the drug major Glenmark Pharmaceuticals along with a request for BE study and Phase III clinical trial study waiver for the proposed fixed-dose combination (FDC) Metformin HCl IP (As extended-release form) 500mg/1000mg plus Glimepiride IP 1mg/1mg plus Lobeglitazone sulfate 0.5mg/0.5mg tablets.
In the above meeting, the committee noted that the proposed FDC is not approved internationally.
After detailed deliberation, the committee opined that the firm should submit the BE study protocol as well as the Phase III clinical trial protocol for the proposed FDC for further review.
