IPCA Lab gets CDSCO panel nod for phase 3 trial of HCQ as add-on therapy in type 2 diabetes

In 2014, the Drug Controller General of India (DCGI) approved hydroxychloroquine for the management of Type 2 Diabetes (T2DM) as an adjunct to diet and exercise to improve glycemic control in patients with T2DM on a combination of sulfonylurea and metformin.

Metformin, which belongs to the biguanide class of antihyperglycemic agents, is the first drug of choice for the treatment of type II diabetes.Metformin decreases blood glucose levels by decreasing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.

The revised phase III protocol presented by IPCA Laboratories was constructed in accordance with a previous SEC recommendation dated 19.01.2021 & 20.01.2021, in which the firm was instructed to include patients with a body weight of less than 60kgs into the protocol and the maximum dose per kg should not exceed the recommended dose of 5mg/kg.

Accordingly, at the 87th SEC committee meeting for Endocrinology & Metabolism, the firm presented the revised phase III protocol for further review by the committee.

After detailed deliberation, the committee recommended the grant of permission for the conduct of the Phase III clinical trial as per the protocol presented.