Phase 3a trial for combination of basal insulin icodec and semaglutide was successfully completed

發(fā)布時(shí)間： 2024-01-10 閱讀：239次

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January 8, 2024-Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. 

COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart (injected 2-4 times a day during mealtimes), dosed with or without oral glucose-lowering medications, in 679 people with type 2 diabetes inadequately controlled on daily basal insulin.

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 (estimated treatment difference: –0.06 percentage points). Further, 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 (estimated treatment difference: -6.7 kg).

In the trial, IcoSema was superior to insulin glargine U100 and insulin aspart in estimated rates of severe or clinically significant (blood glucose below 3.0 mmol/L) hypoglycaemia. In the trial, once-weekly IcoSema appeared to have a safe and well-tolerated profile. The most common adverse events for people treated with IcoSema were gastrointestinal consistent with GLP-1 receptor agonist class and the vast majority were mild to moderate.