Once-a-week insulin bolstered by results of phase 2 clinical trials
For millions of patients with diabetes, daily insulin injections are a necessary nuisance. A once-a-week shot might be more palatable, and new results from phase 2 clinical trials suggest just such a drug is safe and effective.
The drug at the heart of the studies is called icodec, an insulin analog with a half-life of 196 hours – a little over eight days. Developed by Novo Nordisk, the drug works by modifying the insulin molecule to keep it from being broken down by enzymes, and maintains a steady insulin release by binding to proteins produced in the liver.
Back in September 2020, the results of a phase 2 trial of icodec were released, showing that the weekly shot was just as effective at managing patients’ blood sugar levels as the usual daily doses, and had similar numbers of adverse events. The two new studies support this finding.
The first study describes a trial involving 205 patients with Type 2 diabetes from seven countries, to test the efficacy and safety of icodec over 23 weeks. They were divided into four groups – a control group that continued receiving daily injections of insulin, and three experimental groups that received weekly icodec shots. These three groups were treated with different titration algorithms, which are used to calculate the dose required to stabilize a patient’s blood glucose levels.
In all three test groups, the new drug worked well and was well tolerated, with no episodes of severe hypoglycemia recorded.
The second study, involving 154 patients from five countries, focused on determining the best way to transition patients from a daily to a weekly dose. The switch was, again, effective and well tolerated by the patients, but the team found that doubling the first dose significantly increased the time patients spent within their required blood glucose range, without increasing the risk of hypoglycemia.
“A weekly insulin is a game-changer that will decrease the treatment burden for patients while also improving compliance,” says Ildiko Lingvay, an author of both studies. “This treatment will also decrease the burden on those who care for patients with diabetes requiring insulin. For example, for patients who need help injecting, those living in long-term care facilities, and those with memory problems, a once-weekly insulin will facilitate treatment and decrease the burden on the care providers.”
A large phase 3 clinical trial is already underway, which will evaluate the efficacy of weekly icodec doses in patients with either Type 1 or Type 2 diabetes.
Source: UT Southwestern