Conduct Phase III clinical trial: CDSCO to Zydus Healthcare over FDC Empagliflozin plus Sitagliptin

New Delhi: In response to the proposal presented by the drug major Zydus Healthcare, the Subject Expert Committee ( SEC) functional under the Central Standard Drug Control Organisation (CDSCO) has recommended the firm to conduct the Phase III clinical trial of the fixed-dose combination antidiabetic drug of the Empagliflozin plus Sitagliptin.

This came after the firm presented their proposal along with Phase III CT Protocol for two strengths i.e., Empagliflozin plus Sitagliptin (10mg+100mg, 25mg+100mg) tablet and requested for BE study waiver.

Empagliflozin is an antidiabetic agent used in adult patients with type 2 diabetes mellitus. It was FDA-approved in 2014. Empagliflozin can be used as a single agent or as a combination agent with other antidiabetic products.

Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose. The glucose-lowering effect of the drug is independent of insulin.

Sitagliptin is a medicine used to treat type 2 diabetes. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly. This can cause high blood sugar levels (hyperglycaemia).

Its mechanism of action is through inhibition of dipeptidyl peptidase-4 (DPP-4), an enzyme that acts to degrade and inactivate glucagon-like peptide-1 (GLP-1). The elevated GLP-1 level in response to sitagliptin results in increased insulin release after meals, and improved glucose tolerance.

At the SEC meeting for Endocrinology & Metabolism held in October 2023, the expert panel reviewed its proposal along with Phase III CT Protocol for two strengths i.e., Empagliflozin + Sitagliptin (10mg+100mg, 25mg+100mg) tablet and requested for BE study waiver.

After detailed deliberation, the committee considered the request for a BE study waiver and recommended for grant of permission to conduct a Phase III clinical trial.

The results of the study should be presented before the committee for further review.

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