Weekly administration of a new, long-acting basal insulin analogue might be one way to improve the treatment burden in patients with type 2 diabetes.
A phase 2 study randomised 237 adults to either once-weekly subcutaneous insulin icodec plus once-daily placebo, or once-daily subcutaneous glargine and once-weekly placebo for 26 weeks.
Patients were previously on stable daily doses of metformin with or without a DPP4-inhibitor and had HbA1c measures in the range 7.0 to 9.5%.
The study, published in the NEJM and presented at the EASD Annual Meeting, found mean HbA1c improved in the icodec group from 8.09 to 6.69% and in the glargine group from 7.96 to 6.87%.
The estimated mean treatment difference of −0.18 percentage points was not statistically significant (p=0.08).
The proportions of patients reaching a glycated haemoglobin level of less than 7% at week 26 were also similar – 72% in the icodec group and 68% in the glargine group (OR 1.20; 95% CI, 0.98 to 2.13).
The study found about half of the patients in each treatment group experienced an adverse event including injection-site reactions. No serious adverse events were considered likely to be related to the trial medications.
“The observed incidence of level 1 hypoglycaemia alerts was 53.6% in the icodec group and 37.7% in the glargine group, and the observed rates of this end point during the treatment exposure period were 5.09 and 2.11 events per patient-year of exposure for icodec and glargine, respectively (estimated rate ratio, 2.42; 95% CI, 1.50 to 3.88),” the study said.
For both icodec and glargine, the observed incidence of combined level 2 or level 3 hypoglycaemia was low (16.0% and 9.8%, respectively) as were level 1 and level 2 nocturnal hypoglycaemic events.
The study concluded that weekly icodec and daily glargine had similar glucose-lowering effects and similar safety profiles.
“During the trial, a similarly robust reduction in the glycated haemoglobin level was observed with both drugs, with more than two thirds of patients reaching a glycated haemoglobin level of less than 7%; the reduction in the fasting plasma glucose level was also similar in the two groups, and greater improvements in the 9-point patient-measured blood glucose profile were observed with once-weekly insulin icodec than with once-daily glargine, which is currently the most commonly used basal insulin analogue.”
“The findings in the present trial suggest that once-weekly insulin has the potential to facilitate insulin management, providing clinical benefits and reducing the number of injections per year from 365 to 52,” the study said.
The investigators added that once-weekly insulin icodec has the potential to improve treatment satisfaction, adherence, and persistence in patients who are going to receive basal insulin.
“The smaller number of injections associated with once-weekly icodec than with once-daily basal insulin may facilitate treatment initiation in patients with type 2 diabetes who have not previously taken insulin, by reducing clinical inertia and promoting better acceptance of insulin therapy.”