Zydus Healthcare Asked to Revise Phase IV Protocol for Empagliflozin-Metformin Tablets
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has asked for revisions in the Phase IV clinical trial protocol submitted by Zydus Healthcare Limited for its fixed-dose combination (FDC) of Empagliflozin and Metformin Hydrochloride (ER) tablets.
The committee opined that the firm should revise the amended inclusion criteria and provide the justification for the use of the same strength of medications as FDC in patients with uncontrolled diabetes as mentioned in point number 3 of the inclusion criteria.
This came after Zydus Healthcare presented the revised Phase IV clinical trial protocol before the committee.
The vast majority of glucose filtered through the glomerulus is reabsorbed within the proximal tubule, primarily via SGLT2 (sodium-glucose linked co-transporter-2) which is responsible for ~90% of the total glucose reabsorption within the kidneys.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome (PCOS).
Based on these observations, the SEC recommended the following:
" The firm should submit the revised Phase IV CT protocol to CDSCO for further review by the committee."
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