Last Updated on December 31, 2023 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.
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.
Cipla gets USFDA nod for Inhalation product
Zydus Cadila gets tentative nod from USFDA for Fingolimod Capsules
Alkem gets two observations from USFDA for USA plant
Lupin gets USFDA nod for treatment of Kidney patient
Aleor gets USFDA nod for Testosterone Topical Solution
Avenue Therapeutics gets complete response letter from USFDA for IV Tramadol
Copyright – An article (Part-1)
DCGI allows to conduct phase-III clinical trials on C-19 drug
Mankind, BDR Pharma to distribute Baricitinib in India
Dr. Reddy’s Labs launches Icosapent Ethyl Capsules
IPC to sensitize stakeholders on manufacturing of Quality Drugs
Mankind launches drug to treat Diabetes, Heart failure
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
