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  • Revise Phase IV...

Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-06-04T15:01:42+05:30  |  Updated On 4 Jun 2025 3:01 PM IST
Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris
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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.

Also Read: CDSCO Panel Clears Abbott's Phase IV Trial for Empagliflozin + Metformin FDC, Seeks More Sites

eris lifesciencesfixed dose combinationgliclazidesitagliptinfdcphase iv trialcdscosectype 2 diabetessulfonylureadpp-4 inhibitorclinical trial protocolendocrinologymetabolismblood sugar controlinsulin secretiontrial revisionsec committee
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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