New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has opined that Novo Nordisk India should submit further clarifications and supporting data for its proposed Phase IIIb clinical study for IcoSema (700 U/ml plus 2 mg/ml) Insulin Icodec 700 U/ml plus Semaglutide 2.0 mg/ml.

This came after the drug major Novo Nordisk India presented phase IIIb clinical study protocol no. NN1535-8377 Version No. 1.0 dated 30 – Apr - 2025.

The expert panel has saught Scientific justification for the use of Insulin in Type II diabetes patients who were not on prior oral antidiabetic (OAD) drugs. In addition, the panel asked the firm to clarify the inclusion criteria for HbA1c 7.0% (limit 7.0-10%) in the study protocol.

Furthermore, the committee sugg

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