Lupin Gets CDSCO Panel Nod to Study Antidiabetic FDC
New Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) antidiabetic drug, Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin plus Metformin HCl IP (extended-release) (10mg+100mg+1000 mg/25mg+100mg+1000mg) film coated bilayered tablets.
However, this nod is subject to the condition that the trained physician (MD, Internal Medicine) be present during the study.
The fixed-dose combination of Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin plus Metformin Hydrochloride IP (extended-release) (10 mg + 100 mg + 1000 mg and 25 mg + 100 mg + 1000mg) is indicated in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy.
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer," leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
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