Once-weekly insulin icodec non-inferior to daily insulin degludec in patients with type 1 diabetes

1. Mean HbA1c reduction at 26 weeks was comparable in the weekly icodec and daily degludec groups.

2. The risk of hypoglycemia was significantly higher among patients taking weekly insulin icodec compared to those taking daily insulin degludec.

Evidence Rating Level: 1 (Excellent)

Study Rundown: First-line therapy for type 1 diabetes includes a combination of basal and bolus insulin injections. Missed basal injections remain a concern and so, reducing basal insulin injection frequency may lessen treatment burden and improve adherence. Insulin icodec is a once-weekly basal insulin that may provide coverage over a full week; however, limited evidence exists surrounding its efficacy. This randomized controlled trial aimed to assess the non-inferiority of once-weekly insulin icodec versus once-daily insulin degludec in HbA1c reduction. The primary outcome of this study was a change in HbA1c at week 26 while the key secondary outcome was the overall rate of combined clinically significant or severe hypoglycemia during that time. According to study results, both treatments had similar reductions in HbA1c at week 26, although insulin icodec was associated with a significant increase in the risk of severe hypoglycemia. Although this study was well done, it was limited by a higher rate of hypoglycemia with once-weekly icodec, which may have clinical implications for patients with type 1 diabetes.

Click to read the study in The Lancet

Relevant Reading: Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin

In-depth [randomized-controlled trial]: Between Apr 30, 2021, and Oct 15, 2021, 655 patients were screened for eligibility at 99 sites across 12 countries. Included were patients with type 1 diabetes and HbA1c <10.0% (86 mmol/mol). Altogether, 582 patients (290 in once-weekly icodec and 292 in once-daily degludec) were included in the final analysis. The primary outcome of mean change in A1c at week 26 was comparable in both groups (icodec: baseline 7.59%, change -0.47% and degludec: baseline 7.63%, change -0.51%, p=0.0065 for noninferiority). Moreover, the secondary outcome of clinically significant or severe hypoglycemia was significantly higher with icodec than degludec (19.9 vs. 10.4 events per patient-year of exposure, estimated rate ratio 1.9, p<0.0001). This was also the case for serious adverse events (8% in icodec vs. 7% in degludec). Overall, findings from this study suggest that once-weekly icodec is non-inferior to once-daily degludec in terms of HbA1c reduction but has a higher rate of hypoglycemia.

Image: PD

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