New class of once-weekly insulin as effective as daily injections for patients with type 2 diabetes, new research shows

New research published in New England Journal of Medicine and presented at the European Association for the Study of Diabetes (EASD) annual meeting in Madrid (9-13 Sept.) shows that a new class of insulin injected once weekly is as effective as daily insulin injections for effective and safe blood sugar management in patients with type 2 diabetes. The study is by Dr. Carol Wysham, MultiCare Rockwood Center for Diabetes and Endocrinology, Spokane, WA, USA, and colleagues.

When patients with type 2 diabetes find that they can no longer control their blood sugar levels with oral medication, insulin therapy is added and the frequency of injections (daily injections) is one of the main factors that can contribute to non-adherence to treatment (other factors include concerns about weight gain and getting hypos).

Insulin efsitora alfa (efsitora) is a new basal insulin designed for once-weekly administration. Clinical data on safety and efficacy have been limited to small phase 1 or phase 2 studies.

This new phase 3 study compared the effectiveness of once-weekly efsitora with daily injections of insulin degludec (a standard insulin) in adult patients who had not yet started insulin therapy (who were taking multiple oral diabetes medications but had still not reached their glycemic targets).

The authors conducted a 52-week study in which participants were randomly assigned in a 1:1 ratio to receive efsitora or degludec. The primary endpoint was change in glycated hemoglobin (HbA1c – a measure of blood sugar control) from baseline to week 52; they assumed that efsitora would be noninferior to degludec (noninferiority margin, 0.4%).

Secondary and safety endpoints included the change in glycated hemoglobin levels in subgroups of participants who did and did not use the relatively new glucagon-like peptide-1 (GLP-1) receptor agonist antidiabetic agents, the percentage of time glucose levels were in the target range of 70 to 180 mg per deciliter during weeks 48 to 52, and hypoglycemic episodes.

A total of 928 participants were randomly assigned to efsitora (466) or degludec (462). Mean glycated hemoglobin decreased from 8.21% at baseline to 6.97% (absolute change 1.26%) at week 52 with efsitora and from 8.24% to 7.05% (absolute change -1.17%) with degludec; a treatment difference of 0.09% demonstrating a non-inferior reduction in Hb1Ac between efsitora and degludec.

Efsitora was also noninferior to degludec with respect to change in glycated hemoglobin levels in participants who did and did not use GLP-1 receptor agonists. The percentage of time glucose was within target range was 64.3% with efsitora and 61.2% with degludec (estimated treatment difference, 3.1 percentage points; statistically significant).

The rate of combined clinically significant or severe hypoglycemia was 0.58 events per participant-year of exposure to efsitora and 0.45 events per participant-year of exposure to degludec, but this finding was not statistically significant. No severe hypoglycemia was reported with efsitora; six episodes were reported with degludec. The incidence of adverse events was similar in the two groups.

The authors state: “In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora was non-inferior to once-daily degludec in controlling high blood glucose levels by lowering glycated hemoglobin levels.”

They add: “Once-weekly insulin has the potential to simplify dose administration and reduce barriers to insulin therapy initiation through reduced injection burden compared with once-daily insulin. A recent study evaluating preferences for once-weekly basal insulin in adults with type 2 diabetes indicated that both patients and healthcare providers would prefer once-weekly basal insulin over current basal insulin preparations.”

Regarding GLP-1 agonists, they add: “Given treatment guidelines and recommendations to include GLP-1 receptor agonists earlier in treatment, together with their increasing use worldwide, it is relevant to demonstrate that efsitora can be effectively and safely added to such therapy. Here, efsitora demonstrated non-inferiority to degludec with respect to change in glycated hemoglobin levels among participants who did and did not use GLP-1 receptor agonists, with no substantial treatment differences in hypoglycemia between subgroups.”