NovoNordisk gets CDSCO panel okay to study anti-diabetic drug Semaglutide
New Delhi: In line with the drug major Novo-Nordisk's justification for anti-diabetic drug Semaglutide the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to conduct the study.
This came after the firm presented the justification in the recommendation of the expert panel at the meeting of SEC for Endocrinology & Metabolism was held on 20.02.2022.
This nod is subject to condition that echocardiography and digital X-Ray of foot should be mandatory and should be performed for all subjects during screening visit.
In addition the condition includes that the clinical study team in each site should comprise of an Endocrinologist and an Internal medicine specialist or Cardiologist.
Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity.
Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017.
Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose. Semaglutide offers a competitive advantage over other drugs used to manage diabetes, which may require several daily doses. Clinical trials have determined that this drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes.
At the previous SEC meeting conducted for Endocrinology & Metabolism on 20.02.2022, the committee rejected the Phase IIIb clinical trial protocol no NN9535-4533, Version 5.0 Date: 15 October 2021 presented by drug maker Novo-Nordisk and opined that the firm should revise the protocol and consider the following:
1. Echocardiography should be done for all patients during the screening visit
2. Digital X-Ray of the foot should be included during the screening visit
3. All the conditions which affect walking distance like varicose vein, anemia, COPD, etc. should be clearly defined in the protocol.
In addition, the committee also opined that the study team at each site should comprise an endocrinologist and an internal medicine specialist/cardiologist.
In continuation, at the recent SEC meeting for Endocrinology & Metabolism, the firm submitted the revised protocol with justification to the committee in accordance with the recommendation of expert panels.
Later, the committee thoroughly examined the justification for the revised Phase IIIb clinical trial protocol for Semaglutide, the anti-diabetic drug presented by drug maker Novo-Nordisk.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions
1. Echocardiography and digital X-Ray of the foot should be mandatory and should be performed for all subjects during the screening visits.
2. The clinical study team in each site should comprise an Endocrinologist and an Internal medicine specialist/Cardiologist.
