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) 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.
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