Novo Nordisk’s once-weekly IcoSema shows promise in phase 3a type 2 diabetes trial
09 Jan 2024
Clinical ResultPhase 3
Preview
Source: PMLiVE
Novo Nordisk has shared positive topline results from a phase 3a trial of once-weekly IcoSema in type 2 diabetes patients inadequately controlled by daily basal insulin.
The COMBINE 3 study has been comparing a weekly injection of IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide, to daily injections of insulin glargine U100 combined with insulin aspart, dosed with or without oral glucose-lowering medications.
The trial met its primary endpoint, demonstrating non-inferiority in reducing blood glucose levels at week 52 with once-weekly IcoSema compared with daily insulin glargine and insulin aspart.
From an overall baseline HbA1c of 8.30%, once-weekly IcoSema achieved an estimated reduction in HbA1c of 1.47 percentage points compared with 1.40 percentage points for daily insulin glargine and insulin aspart.
Patients receiving once-weekly IcoSema also achieved a superior reduction in the estimated change in body weight as well as lower rates of hypoglycaemia.
More than 4.9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK.
There is currently no cure for type 2 diabetes, with current treatment options focused on disease management, including diet and exercise, diabetes medications and insulin therapy.
It is hoped that the introduction of a weekly treatment option could lead to improved adherence rates and an overall higher quality of life for patients.
Martin Holst Lange, executive vice president for development at Novo Nordisk, said the results from COMBINE 3 “demonstrate the potential of IcoSema to simplify insulin intensification by reducing the injection burden to a single injection per week compared to around 28 injections per week for people with type 2 diabetes inadequately controlled on basal insulin”.
The readout comes less than two months after Novo said it would be investing more than $2.3bn to expand its existing production site in France "for the current and future product portfolio within serious chronic diseases”.
The investment will "significantly increase" the capacity of the Chartres manufacturing facility, Novo said, including for its GLP-1 products in the cardiometabolic disease space.
The company also recently said it would be investing $6bn to expand its manufacturing facilities in Denmark, noting that the funds would "create additional capacity across the entire global value chain,” including for the manufacturing of active pharmaceutical ingredients.
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