Glenmark gets CDSCO panel nod for Phase III CT of antidiabetic FDC drug
New Delhi: Considering the drug major Glenmark's request for bioequivalence (BE) study waiver, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended conducting the Phase III clinical trial of fixed-dose combination drug-containing Lobeglitazone sulfate 0.5mg and Dapagliflozin 10mg tablet.
This came after the firm presented its proposal along with Phase III CT protocol as well as justification for BE study waiver.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.
Dapagliflozin is mainly used to treat type 2 diabetes. It can also be used to treat heart failure and chronic kidney disease (CKD). Dapagliflozin is usually prescribed if: you have type 2 diabetes and cannot take metformin.
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 hemoglobin A1C (HbA1C) levels, and improve lipid and liver profiles.
Lobeglitazone acts as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells. By 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 the 20th and 21st of April 2023, the expert panel reviewed the along with Phase III CT protocol as well as justification for BE study waiver of the FDC of Lobeglitazone sulfate 0.5mg plus Dapagliflozin 10mg tablet.
After detailed deliberation, the committee considered the request of the firm for BE study waiver and recommended conducting the Phase III CT for the FDC of Lobeglitazone sulfate 0.5mg plus Dapagliflozin 10mg tablet.
Furthermore, the expert panel directed that the result of the study should be presented before the committee for review.
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