ClinicalTrials.gov posted phase 3 results on 2022-08-12 for NCT04760626, a completed study of once-weekly insulin icodec in people with type 2 diabetes who had not used insulin before. The trial enrolled 1,085 participants and compared insulin icodec with daily basal insulin analogues.

Background

The study evaluated treatment with insulin icodec versus once-daily basal insulin analogues in diabetes mellitus, type 2. The posted record also lists insulin glargine 100u/ml, insulin degludec, and insulin glargine 300u/ml among the interventions.

Trial design

This was a phase 3 randomized comparison in insulin-naive adults with type 2 diabetes. The record states that participants received either once-weekly insulin icodec or a marketed insulin taken once daily, with treatment assignment decided at random.

Key results

For change in glycated haemoglobin, the least-squares mean was -1.68 percentage points with insulin icodec versus -1.31 percentage points with once-daily basal insulin analogue. The treatment difference was -0.38 percentage points, with a 95.0% CI of -0.66 to -0.09 and p=0.0001.

Median time from baseline to treatment discontinuation or intensification was 20.1 weeks with insulin icodec and 13.9 weeks with once-daily basal insulin analogue. Treatment satisfaction scores were 4.68 versus 3.90 on the DTSQs total treatment satisfaction measure, and TRIM-D compliance scores were 90.42 versus 87.37.

Severe hypoglycaemic episodes were reported as 0 with insulin icodec and 5 with once-daily basal insulin analogue. Clinically significant hypoglycaemic episodes were 104 with insulin icodec and 76 with once-daily basal insulin analogue.

What this means

The posted results suggest that weekly insulin icodec lowered HbA1c more than daily basal insulin in this insulin-naive type 2 diabetes population. The record also shows mixed hypoglycaemia counts and higher patient-reported satisfaction and compliance scores with insulin icodec, which may matter for future prescribing decisions if these findings are confirmed in full study reporting.

Source

This information is based on ClinicalTrials.gov results for NCT04760626 posted on 2022-08-12. The record is available at clinicaltrials.gov.