Expert Panel Flags Gaps in Mascot Health's Diabetes FDC Trial, Seeks Revised Phase IV Protocol
New Delhi: The Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Committee (SEC) on Endocrinology and Metabolism has recommended Mascot Health Series Pvt Ltd to submit a revised Phase IV clinical trial protocol for its fixed dose combination (FDC) of Glimepiride IP, Voglibose IP, and Metformin Hydrochloride IP (ER), after identifying key gaps in the study design and withholding approval until necessary modifications are made.
The decision was taken during the SEC meeting held at CDSCO headquarters, where the firm presented its Phase IV clinical trial protocol in line with the conditions specified in the earlier permission granted under Form CT-23 dated January 9, 2023.
During detailed deliberations, the committee observed that the protocol lacks clarity in patient selection criteria. It specifically instructed the firm to include an upper limit for HbA1c levels in the inclusion criteria to ensure appropriate enrolment and improve the scientific robustness of the study outcomes.
Further, raising concerns regarding patient safety, the SEC recommended expanding the exclusion criteria to include patients suffering from Chronic Inflammatory Bowel Disease (IBD) and gastrointestinal ulceration, considering potential risks associated with the drug combination.
The committee also noted the absence of a scientific justification for the proposed sample size. It directed the firm to submit a detailed rationale to ensure statistical validity and reliability of the clinical trial findings.
In view of these observations, the SEC concluded that the protocol requires revisions before further consideration. Accordingly, the firm has been asked to submit a revised Phase IV clinical trial protocol incorporating all recommendations for further evaluation by CDSCO.
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