HQ Team
January 9, 2023: Denmark’s Novo Nordisk declared its late-stage experimental once-weekly diabetes drug IcoSema achieved its primary endpoint of proving “non-inferiority” in lowering blood sugar levels.
A trial compared the HbA1c levels of patients treated with IcoSema with once-daily insulin glargine U100 and insulin aspart — injected 2-4 times a day during mealtimes.
A total of 679 type 2 diabetic patients were also dosed with or without oral glucose-lowering medications, inadequately controlled on daily basal insulin.
“The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 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 insulin glargine U100 and insulin aspart — an estimated treatment difference of -0.06 percentage points,” according to a company statement.
Weight loss
Additionally, from a baseline body weight of 85.8 kg, people treated with IcoSema achieved a superior reduction in estimated change of body weight a weight loss of -3.6 kg with IcoSema and a weight gain of 3.2 kg with insulin glargine U100 and insulin aspart, a difference of -6.7 kg.
HbA1c is the average blood glucose or sugar levels for the last two to three months. For a diabetic patient, an ideal HbA1c level is 48mmol/mol (6.5%) or below. If one it at the risk of developing type 2 diabetes, the target HbA1c level should be below 42mmol/mol (6%).
“The results 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 while providing glycaemic control as well as weight benefits and lower rates of hypoglycaemia,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk.
IcoSema is a fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide (700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (i350 U insulin icodec/1mg semaglutide).
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