Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy

Area of Science:

• Endocrinology
• Metabolic Diseases
• Pharmacology

Background:

• Traditional basal insulin regimens require frequent dose adjustments based on fasting blood glucose.
• A fixed-dose, once-weekly basal insulin like efsitora alfa (efsitora) may offer an alternative for type 2 diabetes management.
• This study evaluated efsitora in insulin-naive adults with type 2 diabetes.

Purpose of the Study:

• To assess the noninferiority of once-weekly efsitora compared to once-daily insulin glargine U100 (glargine) in adults with type 2 diabetes.
• To evaluate glycemic control, hypoglycemia rates, and insulin dose requirements.

Main Methods:

• A 52-week, phase 3, open-label, treat-to-target trial.
• 795 insulin-naive adults with type 2 diabetes were randomized 1:1 to receive weekly efsitora or daily glargine.
• Primary endpoint: change in glycated hemoglobin (HbA1c) from baseline at 52 weeks, tested for noninferiority.

Main Results:

• Efsitora was noninferior to glargine in reducing HbA1c (mean change -1.19% vs. -1.16%, difference -0.03 percentage points).
• The rate of clinically significant or severe hypoglycemia was lower with efsitora (0.50 events/participant-year) compared to glargine (0.88 events/participant-year).
• Efsitora required fewer dose adjustments (median 2) compared to glargine (median 8).

Conclusions:

• Once-weekly efsitora, using a fixed-dose regimen, is noninferior to once-daily glargine for glycemic control in insulin-naive type 2 diabetes patients.
• Efsitora offers a potential benefit of reduced hypoglycemia and simplified dosing compared to daily basal insulin.