Glenmark Pharmaceuticals Gets CDSCO Panel Nod to Study Lobeglitazone Sulfate, Glimepiride FDC Table
New Delhi: Glenmark Pharmaceuticals, a major pharmaceutical company, has received approval from the Subject Expert Committee (SEC) operating under the Central Drugs Standard Control Organisation (CDSCO) to conduct Phase IV clinical trials for the antidiabetic drug combination of Lobeglitazone Sulfate 0.5 mg and Glimepiride 1 mg tablet.
However, this approval is subject to the condition that the firm should defined the upper limit for HbA1c, specifically not more than 9%, under the inclusion criteria.
This came after Glenmark Pharmaceuticals presented their proposal for the grant of permission to conduct Phase IV clinical trials for the Lobeglitazone Sulfate 0.5 mg and Glimepiride 1 mg tablet.
Lobeglitazone is an antidiabetic medication belonging to the thiazolidinedione class, primarily functioning as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells. By activating PPAR-gamma and promoting insulin binding at fat cells, lobeglitazone has been shown to reduce blood sugar levels, lower HbA1c levels, and improve lipid and liver profiles.
Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes, either alone or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to transport sugar into the body's cells where it can function effectively.
During the recent SEC meeting for Endocrinology and Metabolism held on March 21, 2024, the expert panel reviewed Glenmark's proposal for permission to conduct Phase IV clinical trials for the Lobeglitazone Sulfate 0.5 mg and Glimepiride 1 mg tablet.
Following extensive deliberation, the committee recommended conducting Phase IV clinical trials with drug FDC of Lobeglitazone Sulfate 0.5 mg and Glimepiride 1 mg tablet as per the presented protocol, with the condition that the firm should defined the upper limit for HbA1c, specifically not more than 9%, under the inclusion criteria.
