A once-weekly insulin injection may soon change the rhythm of diabetes care.
In a global phase 3 trial that spanned 3 countries and almost 800 participants, investigational basal insulin efsitora proved to be just as effective as daily glargine at lowering long-term blood glucose in adults with type 2 diabetes who were new to insulin. The results of the QWINT-1 trial were unveiled at the American Diabetes Association’s 85th Scientific Sessions.
Led by Julio Rosenstock, MD, of Velocity Clinical Research at Medical City in Dallas, the researchers evaluated changes in glycated hemoglobin (HbA1c), a key indicator of long-term glycemic control. At baseline, HbA1c levels averaged 8.2% in the efsitora group and 8.28% in the glargine group. After 52 weeks, levels declined to 7.05% with efsitora and 7.08% with glargine. The between-group difference (−0.03 percentage points, 95% confidence interval [CI] = −0.18–0.12) confirmed efsitora's noninferiority.
Rates of clinically significant or severe hypoglycemia were lower with efsitora, at 0.50 events per participant-year of exposure, compared with 0.88 with glargine (rate ratio = 0.57, 95% CI = 0.39–0.84). One episode of severe hypoglycemia occurred in each group.
By week 52, 57% of patients receiving efsitora and 52% receiving glargine achieved HbA1c levels below 7%. A higher percentage of patients in the efsitora group reached this target without clinically significant or severe hypoglycemia (41% vs 33%).
Fasting blood glucose levels declined similarly in both groups—from approximately 182 mg/dL at baseline to 127.7 mg/dL with efsitora and 126.7 mg/dL with glargine.
At week 52, the average weekly insulin dose was lower with efsitora (289.1 units) than with glargine (332.8 units). Median dose adjustments were also fewer in the efsitora group (2 vs 8).
Most patients on efsitora (76%) remained on fixed doses using prefilled autoinjectors throughout the trial. The rest transitioned to variable dosing with a multidose pen if fasting glucose remained above target after reaching the 400-unit dose.
Adverse events were reported in 59.9% of participants on efsitora and 65.1% on glargine. Serious adverse events occurred in 6.5% and 5.3% of participants, respectively. Each group reported 3 deaths, none of which were attributed to the study drugs.
Average weight gain was reported at 3.9 kg in the efsitora group and 3.3 kg in the glargine group.
Efsitora's comparable glycemic control with fewer hypoglycemic events supports its once-weekly fixed-dose as a potential alternative to daily basal insulin in insulin-naive adults with type 2 diabetes.
The study was funded by Eli Lilly and registered under ClinicalTrials.gov number NCT05662332.
Full disclosures can be found in the published study.