Submit complete CT Report :CDSCO Tells Glenmark on antidiabetic FDC drug

This came after the drug maker Glenmark presented their proposal for manufacturing and marketing of Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets along with safety efficacy and safety data.

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.

Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome(PCOS).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.

At the recent SEC meeting for Endocrinology and Metabolism held on 9th September 2022, the expert panel reviewed the proposal presented by the Glenmark to manufacture and market the fixed dose combination (FDC) anti- diabetic drug Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets.

After detailed deliberation, the committee recommended that the firm should submit the complete clinical trial & present the report before the committee for further consideration.

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