Submit Phase III CT Protocol: CDSCO Panel Tells Glenmark Pharmaceuticals on Antidiabetic FDC
New Delhi: Citing that the proposed fixed-dose combination (FDC) of antidiabetic drug Metformin HCl plus Glimepiride plus Lobeglitazone sulfate tablet 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 for the proposed FDC.
This came after Glenmark Pharmaceuticals presented its proposal along with the request for a BE study and Phase III clinical trial study waiver.
Metformin is in a class of drugs called biguanides. Metformin is a medicine used to treat type 2 diabetes and gestational diabetes. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly.
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 medication used to manage and treat type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. Glimepiride is a medication used to manage and treat type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. Sulfonylureas are one of the insulin secretagogues widely used for the management of type 2 diabetes to lower blood glucose levels. 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 has been shown to reduce blood sugar levels, lower hemoglobin 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 along with a request for BE study and Phase III clinical trial of the FDC Metformin HCl plus Glimepiride plus Lobeglitazone sulfate.
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.
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