CDSCO Panel seeks clarifications from Novo Nordisk on IcoSema phase IIIb clinical study protocol
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 suggested the firm submit Phase II study data for the use of Insulin in patients with Type II diabetes (HbA1c 7.0-10.0%).
IcoSema is an investigational, once-weekly combination therapy for type 2 diabetes that contains insulin icodec (700 U/mL) and semaglutide (2.0 mg/mL) in a single injection.
Active ingredients of IcoSema are
Insulin icodec: A novel, ultra-long-acting basal insulin analog designed for once-weekly administration.
Semaglutide: A long-acting GLP-1 (glucagon-like peptide-1) receptor agonist.
IcoSema combines the blood sugar-lowering effects of both insulin and a GLP-1 receptor agonist. Insulin icodec works by binding to albumin in the bloodstream, creating an inactive, circulating depot that provides a slow and continuous insulin action throughout the week.
Semaglutide mimics the natural hormone GLP-1, which stimulates insulin secretion, suppresses glucagon release, and slows gastric emptying in a glucose-dependent manner.
The combination therapy is intended for adults with type 2 diabetes whose condition is inadequately controlled with their current treatment regimen. Clinical trials have studied IcoSema in people previously treated with daily basal insulin or GLP-1 receptor agonists.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the phase IIIb clinical study protocol no. NN1535-8377 Version No. 1.0 dated 30 – Apr - 2025, presented by Novo Nordisk India.
After detailed deliberation, the committee opined that the firm should submit the following for further review by the committee:
1. Scientific justification for use of Insulin in Type II diabetes patients who were not on prior OAD drugs.
2. Clarification for inclusion criteria for HbA1c 7.0% (limit 7.0-10%) in study protocol.
3. Phase-II study data for use of Insulin in Type II diabetes with patients (HbA1c 7.0-10.0%)
