Include more Govt sites in Dapagliflozin, Teneligliptin FDC phase 3 trial: CDSCO panel tells Macleods Pharma
New Delhi: Macleods Pharmaceutical has recently received permission from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the proposed bioequivalence (BE) study and Phase III Clinical Trial (CT) study of the popular antidiabetic Fixed Dose Combination (FDC) drug Dapagliflozin premix (5mg/10mg) plus Teneligliptin Hydrobromidehydrate IP (20mg/20mg) tablets.
However, the approval by the CDSCO expert panel has been granted based on the condition that the firm should include a few more government sites in the Phase III CT study.
This came in the wake of the proposal presented by the pharmaceutical major Macleods Pharma along with the BE protocol and Phase III Clinical Trial Protocol before the committee at the 88th SEC meeting for Endocrinology and Metabolism held on 14.07.2021 and 15.07.2021 at CDSCO.
Dapagliflozin is a sodium-glucose cotransporter 2 (SGL-2) inhibitor that is used to treat type 2 diabetes. In adults, dapagliflozin improves glycemic control by blocking glucose resorption in the proximal tubule of the nephron and producing glycosuria when used in conjunction with diet and exercise. On January 8, 2014, the FDA approved dapagliflozin. In India, a few popular brand names of Dapagliflozin are Sun Pharma's Oxra 10mg Tablet, Astra Zeneca's Forxiga 10 mg Tablet etc.
Teneligliptin is an oral dipeptidyl peptidase 4 (DPP-4) inhibitor indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. By inhibiting DPP-4, teneligliptin prevented the degradation of incretins Glucagon-like peptide-1 (GLP-1), Gastric inhibitory polypeptide (GIP) and promoted insulin release, which prevented blood glucose increase after food intake.
The Fixed Dose Combination (FDC) of the above mentioned two anti-diabetic drugs, SGL2 inhibitor and DPP-4 inhibitor, is indicated to treat type 2 diabetes.
The BE protocol and Phase III Clinical Trial Protocol presented by Macleods Pharmaceutical were minutely scrutinized by the Committee at its latest SEC meeting for Endocrinology and Metabolism.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BE study and Phase III CT study. In addition to this, the committee recommended that the firm should include a few more government sites in the Phase III CT study.