What is insulin icodec?

Insulin icodec is an experimental once-weekly insulin injection that may be used to treat type 2 diabetes. It is currently undergoing phase 3 trials.

A decision from the FDA is expected in April 2024. If approved, it will be the world’s first once-weekly insulin.

How does insulin icodec work?

Icodec is an analog of human insulin analogue that has had its amino acid structure modified so that it will bind irreversibly to albumin, which prolongs its half-life to 196 hours (approximately 7 days). Steady levels in the blood are reached after 3 to 4 once-weekly injections.

One unit of icodec provides the same glucose-lowering as one unit of comparator daily basal insulins, and an equivalent once-weekly dose is usually seven times that of daily basal insulin.
Insulin icodec works like any other insulin, by replacing or topping up naturally occurring insulin in the body of people with type 2 diabetes who have little or no natural insulin release. The main role of insulin is to allow cells throughout the body to uptake glucose (sugar) and convert it into a form that can be used by these cells for energy. Naturally occurring human insulin is made by beta cells within the pancreas.

How is insulin icodec given?

Insulin icodec is given by subcutaneous (under the skin) injection once a week.

Compared with daily basal insulin, only one injection is needed per week compared to 7 with currently availably once-daily insulins.

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How effective is insulin icodec?

Insulin icodec demonstrated non-inferiority and superiority to insulin degludec in a trial by Philis-Tsimikas, et al., (ONWARDS 2) of 526 people: icodec (n=263) or degludec (n=263).
HbA1c was reduced to a greater extent with icodec than degludec (7·20% vs 7·42% [55·2 vs 57·6 mmol/mol], respectively) at week 26.

• This resulted in an estimated treatment difference (ETD) of −0·22 percentage points (95% CI −0·37 to −0·08) or −2·4 mmol/mol (95% CI −4·1 to −0·8), demonstrating non-inferiority (p<0·0001) and superiority (p=0·0028).
• Body weight change was slightly greater with icodec by week 26 at +1·40 kg for icodec and −0·30 kg for degludec (ETD 1·70 [95% CI 0·76 to 2·63]).
• 61% of people receiving icodec and 51% of those receiving degludec reported an adverse event; overall rates of combined level 2 or level 3 hypoglycemia were 0·73 [icodec] vs 0·27 [degludec]; estimated rate ratio 1·93 [95% CI 0·93 to 4·02]).

More people achieved an HbA1c target of <7.0% without experiencing clinically significant or severe hypoglycemia compared with once-daily basal insulin comparators at 52 and 26 weeks, in the ONWARDS 1 and 3 trials.

Who makes insulin icodec?

Novo Nordisk.