Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC
New Delhi: Approving to conduct the bioequivalence (BE) study of the antidiabetic drug combination Repaglinide plus Voglibose plus Metformin Hydrochloride (SR) uncoated bilayered tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akum Pharmaceutical that the Phase III clinical trial protocol should be adequately modified concerning inclusion criteria, exclusion criteria, withdrawal criteria, provision of rescue therapy, sample size calculation etc.
This came after Akum Pharmaceutical presented its proposal along with a BE study and Phase III clinical trial protocol.
Repaglinide is an antihyperglycemic used to improve glycemic control in diabetes. Repaglinide is an insulin secretagogue, meaning it binds to receptors on pancreatic beta cells and stimulates insulin release. Repaglinide binds to an ATP-dependent potassium channel on beta cells, known as SUR1, bringing about its closure.
Voglibose belongs to a class of competitive α glucosidase inhibitors (α-GIs). Voglibose is used to reduce high post-meal glucose levels in diabetes mellitus in patients who have been using other diabetic medications. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Voglibose is an anti-diabetic medicine.
Metformin is an oral anti-diabetic drug in the biguanide class for the treatment of type 2 diabetes mellitus, in particular, in overweight and obese people and those with normal kidney function.
Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
At the recent SEC meeting for Endocrinology and Metabolism held on 23 November 2023, the expert panel reviewed the proposal along with the BE study and Phase III clinical trial protocol of the FDC Repaglinide plus Voglibose plus Metformin Hydrochloride (SR) uncoated bilayered tablet.
After detailed deliberation, the committee recommended a grant of permission to conduct the proposed BE study.
In addition to the above, the expert panel opined that the Phase III clinical trial protocol should be adequately modified with respect to inclusion criteria, exclusion criteria, withdrawal criteria, provision of rescue therapy, sample size calculation, etc.
Accordingly, the committee suggested that the BE study reports should be presented before the SEC along with the revised Phase III clinical trial protocol.
Also Read: Dr. Reddy's Gets CDSCO Panel Nod to Study FDC Etoricoxib plus Thiocolchicoside for Export purpose
