IPCA Lab gets CDSCO nod to conduct Phase-III study of HCQ

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

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CDSCO DCGI FDA

Last Updated on June 27, 2021 by The Health Master

IPCA Laboratories Ltd has received approval from the subject expert committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) to conduct phase III study of antimalarial drug hydroxychloroquine (HCQ) as an add-on therapy in type 2 diabetes patients uncontrolled on metformin monotherapy.

In light of recommendations of the earlier committee meeting held on January 19-20, 2021, the drug firm presented the revised phase III clinical trial protocol before the committee at its 87th meeting on June 15-16, 2021.

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

Earlier, the drug maker presented the phase III clinical trial protocol of HCQ when used as an add-on therapy in type 2 diabetes patients uncontrolled on metformin monotherapy at SEC meeting on January 19-20, 2021.

Laboratory
Picture: Pixabay

After detailed deliberation, the committee opined that the firm should also include the patients with body weight with less than 60kgs and the maximum dose per kg shall not exceed the recommended dose of 5mg/kg. Accordingly, the firm should revise the phase III clinical trial protocol and present before the committee for further review.

Type 2 diabetes is one of the most common metabolic diseases, with its prevalence increasing in the country.

Metformin is widely used as an oral agent for the treatment of type 2 diabetes. It is recommended as an initial monotherapy. It helps in weight loss and has a record of efficacy and safety, with a very low risk of hypoglycaemia.

However, there are several instances wherein metformin alone has proved insufficient to control type 2 diabetes. It underlined the need for second-line treatment options to achieve desired HbA1c level in people with type 2 diabetes.

HCQ, commonly prescribed medication in the treatment of uncomplicated malaria, rheumatoid arthritis, chronic discoid lupus erythematosus, and systemic lupus erythematosus, was approved by Drugs Controller General of India (DCGI) in 2014 as a third line add-on treatment in type 2 diabetes patients uncontrolled on metformin.

HCQ most likely acts by decreasing the lysosomal degradation of internalised insulin-insulin receptor complex. This is a novel mechanism of action in contrast to insulin secretagogue or insulin sensitizer action of other antidiabetic drugs. It leads to a significant reduction in total daily insulin dose and HbA1c level.

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