Sun Pharma Laboratories Gets CDSCO Panel Nod To study Antidiabetic FDC Drug
New Delhi: The drug major Sun Pharma Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Glimepiride plus Extended Release Metformin Hydrochloride Tablets (10 mg + 1 mg + 1000 mg) and (10 mg + 2 mg + 1000 mg) Tablets.
This came after Sun Pharma Laboratories presented the Phase IV clinical trial protocol before the committee in light of the condition mentioned in permission in Form CT-23 dated 10.10.2023.
Dapagliflozin plus Glimepiride plus Metformin is a combination of three antidiabetic medications.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron.SGLT2 facilitates 90% of glucose reabsorption in the kidneys, and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
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