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.

Glimepiride is a sulfonylurea drug used to treat type 2 diabetes mellitus. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.

Metformin is a biguanide antihyperglycemic agent and a 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.

Dapagliflozin plus glimepiride plus metformin is used in the treatment of type 2 diabetes mellitus.

At the recent SEC meeting for endocrinology and metabolism held on June 11, 2024, the expert panel reviewed the Phase IV clinical trial protocol of the antidiabetic FDC drug Dapagliflozin Propanediol Monohydrate plus Glimepiride plus Metformin Hydrochloride Tablets.

After detailed deliberation, the committee recommended a grant of permission to conduct the Phase IV clinical trial.

In view of the above, the expert panel suggested that the firm submit the Phase IV clinical trial report to CDSCO.

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