Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris
New Delhi: Reviewing the Phase IV clinical trial of Eris Lifesciences' Fixed Dose Combination (FDC) antidiabetic drug Gliclazide plus Sitagliptin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined to revise the inclusion and exclusion criteria with scientific justification among various other observations.
Accordingly, the committee recommended the firm to submit the revised Phase IV clinical trial protocol to CDSCO for further review by the committee.
This came after the firm presented the Phase IV clinical trial protocol before the committee for FDC/CT/25/000037, Gliclazide SR 30mg/60mg + Sitagliptin 100mg/100mg tablets.
Gliclazide belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release.
Gliclazide is used to treat type 2 diabetes. It's a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar. Type 2 diabetes is a condition where the body does not make enough insulin, or makes insulin that does not work properly
Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high.
Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).
At the recent SEC meeting for Endocrinology and Metabolism held on 14th May 2025, the expert panel reviewed the Phase IV clinical trial protocol before the committee.
After detailed deliberation, the committee opined the following modification:
1. Inclusion and exclusion criteria should be revised with scientific justification.
2. Withdrawal criteria should be mentioned in the protocol.
3. Study duration should be 24 weeks.
4. Patient not controlled with Metformin alone should be given two drugs with stratification that who is going to receive 30mg and who is going to receive 60mg.
Accordingly, the firm should submit the revised Phase IV clinical trial protocol to CDSCO for further review by the committee.
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