Dr Reddy's Gets CDSCO Panel Nod to Study Antidiabetic FDC Empagliflozin, Sitagliptin, Metformin tablet
New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial (CT) of the fixed-dose combination antidiabetic drug Empagliflozin plus Sitagliptin Phosphate Monohydrate plus Metformin hydrochloride tablets.
However, this approval is subject to the condition that the firm should submit the bioequivalence (BE) study report before the initiation of Phase III CT.
This came after Dr Reddy's Laboratories presented its proposal along with the BE study protocol as well as the Phase III CT Protocol.
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 of glucose.
Sitagliptin phosphate monohydrate is an oral antihyperglycemic (antidiabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Sitagliptin phosphate works by competitively inhibiting the enzyme dipeptidyl peptidase 4 (DPP-4).
Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.
Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Metformin exerts its prevailing, glucose-lowering effect by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.
At the recent SEC meeting for Endocrinology and Metabolism held on 27th and 29th September 2023, the expert panel reviewed the proposal along with the BE study protocol as well as the Phase III CT protocol of the FDC antidiabetic drug Empagliflozin plus Sitagliptin Phosphate Monohydrate plus Metformin hydrochloride tablets.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BE study and Phase III CT Study.
The committee also recommended that the BE study report should be presented in the SEC meeting before the initiation of the clinical trial.
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