Conduct Phase III CT: CDSCO Panel Tells Akum Pharmaceutical on Antidiabetic FDC
New Delhi: Rejecting the proposal for the clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akum Pharmaceutical to conduct a Phase III clinical study of antidiabetic fixed dose combination, Metformin Hydrochloride IP (SR) plus Glimepride IP plus Sitagliptin Phosphate Monohydrate IP eq....
New Delhi: Rejecting the proposal for the clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akum Pharmaceutical to conduct a Phase III clinical study of antidiabetic fixed dose combination, Metformin Hydrochloride IP (SR) plus Glimepride IP plus Sitagliptin Phosphate Monohydrate IP eq. To Sitagliptin (1000mg/1000mg + 1mg/2mg + 50mg/50mg) film-coated bilayered tablet.
This came after Akum Pharmaceuticals presented its proposal, a bioequivalence (BE) study report, and justification for clinical trial waiver before the committee.
Metformin is an oral anti-diabetic drug in the biguanide class for the treatment of type 2 diabetes mellitus. Metformin's mechanism of action is the alteration of the cell's energy metabolism. Metformin exerts its prevailing, glucose-lowering effect by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.
Metformin is a medicine used to treat type 2 diabetes and gestational diabetes. It's also used to help prevent type 2 diabetes if you're at high risk of developing it. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly.
Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.
Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas cannot get sugar into the cells of the body where it can work properly.
Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (a 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 23 November 2023, the expert panel reviewed the proposal presented by the drug major Akum Pharmaceutical along with the BE study report and justification for CT waiver of the FDC Metformin Hydrochloride plus Glimepride plus Sitagliptin Phosphate Monohydrate film-coated bilayered tablet
After detailed deliberation, the committee considered the BE study report.
However, the committee did not agree to the justification for the clinical trial waiver and recommended conducting a Phase III CT study for which CT NOC had already been issued on 16.09.2022.
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