Torrent Pharma Gets CDSCO Panel Nod To study antidiabetic FDC Empagliflozin plus Sitagliptin
New Delhi: The drug major Torrent Pharmaceutical has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the fixed-dose combination (FDC) antidiabetic drug of the Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. Sitagliptin (10mg+100mg/ 25mg+100mg)...
New Delhi: The drug major Torrent Pharmaceutical has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the fixed-dose combination (FDC) antidiabetic drug of the Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. Sitagliptin (10mg+100mg/ 25mg+100mg) film-coated tablets.
This came after Torrent Pharmaceutical presented its proposal along with a revised Phase III clinical trial protocol before the committee.
Empagliflozin is a sodium-glucose co-transporter (SGLT-2) class of medication for diabetes.
Empagliflozin is used to treat type 2 diabetes. It works in the kidneys to prevent the absorption of glucose (blood sugar). This helps lower the blood sugar level. Empagliflozin does not help patients who have insulin-dependent or type 1 diabetes.
Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. Sitagliptin inhibits DPP-4 which leads to increased levels of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide(GIP), decreased levels of glucagon, and a stronger insulin response to glucose
Inhibition of DPP-4 by sitagliptin slows DPP-4 mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control which is demonstrated by reduced glycosylated hemoglobin (HbA1c).
At the recent SEC meeting for Endocrinology and Metabolism held on 14th December 2023, the expert panel reviewed the proposal presented by the drug major Torrent Pharmaceuticals along with the revised Phase III clinical trial protocol of the antidiabetic drug Empagliflozin plus Sitagliptin Phosphate Monohydrate.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase III clinical trial as per the revised protocol.
Furthermore, the expert panel suggested that the firm should submit a Phase III clinical trial report to CDSCO for further review by the committee.
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