Glenmark gets CDSCO Panel nod to study antidiabetic FDC containing Dapagliflozin, Sitagliptin, Metformin
New Delhi: Granting the waiver of bioequivalence study, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Glenmark Pharmaceuticals to conduct a Phase III clinical trial of antidiabetic fixed dose combination drug containing Dapagliflozin Propanediol Monohydrate Eq.to Dapagliflozin 5mg/5mg, Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin 50mg/50mg, Metformin Hydrochloride IP 500/1000mg.
This came after the firm presented their proposal before the committee along with justification for bioequivalence (BE) study waiver and Phase III Clinical Trial protocol.
Based on the Biopharmaceutics Classification System (BCS), the committee considered the justification for bioequivalence (BE) study waiver. The Biopharmaceutics Classification System (BCS) is a system classifying a drug substance (API) based on its minimum aqueous solubility in the pH range of 1–7.5, dose and human fraction absorbed or intestinal membrane permeability.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. It inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption 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.
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. Inhibition of DPP-4 by sitagliptin slows DPP-4 mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increase insulin synthesis and decrease glucagon release in a manner dependant on glucose concentrations. These effects lead to an overall increase in blood glucose control which is demonstrated by reduced glycosylated hemoglobin.
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Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.
At recent SEC meeting for Endocrinology & Metabolism, the committee evaluated the proposal presented by drug-maker Glenmark Pharmaceuticals.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III CT.
Furthermore, the expert panel directed that the result of the study should be presented before the committee for further consideration.
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