CDSCO Panel Recommends Key Changes in Phase III Study of Glimepiride-Linagliptin FDC

New Delhi: Considering the bioequivalence (BE) study report for Glimepiride 1 mg/2 mg plus Linagliptin 5 mg/5 mg Tablets, the Subject Expert Committee, functioning under the Central Drugs Standard Control Organisation, has opined Pure and Cure Healthcare should revise the Phase III clinical trial in line with the exclusion criteria and it suggested including details regarding how hypoglycemic episodes will be captured.

Furthermore, the expert panel suggested that HbA1c levels should be assessed at baseline, at the 12th week, and at the 24th week and periodic self-monitoring of blood glucose should be carried out by patients using a standard glucometer, and the readings should be properly recorded.

This came after the firm presented their proposal along with BE study report and revised Phase III clinical trial protocol before the committee.

Glimepiride and linagliptin is an oral anti-diabetic combination used in the management of Type 2 Diabetes Mellitus. Glimepiride is a sulfonylurea that helps lower blood glucose by stimulating insulin secretion from pancreatic beta cells, while linagliptin is a DPP-4 inhibitor that improves glycemic control by increasing incretin levels, thereby enhancing insulin release and decreasing glucagon levels.

After detailed deliberation, the committee considered the BE study report submitted by the firm.

With regard to the Phase III clinical trial protocol, the committee made the following observations and recommendations:

1. The exclusion criteria should mention that fasting glucose more than or equal to 200 mg/dl will be excluded from the study.

2. Details regarding how hypoglycemic episodes will be captured should be mentioned in the protocol.

3. HbA1C should be checked at baseline, at the 12th week and 24th week.

4. Periodic self-monitoring of blood glucose should be done and recorded by the patients with a standard glucometer.

In line with the above, the expert panel suggested that the firm should submit the revised Phase III clinical trial (CT) Protocol to CDSCO. After approval from CDSCO, the firm should submit the Phase III CT report to CDSCO for further review by the committee.