Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once‐weekly dosing for the treatment of patients with diabetes
Authors' conclusion
BIF was well tolerated and the PK/PD profile enabled once-weekly dosing with minimal variation in exposure in a treatment interval of 1 week. The findings suggest BIF is suitable for further development as a weekly basal insulin in people with diabetes.
Study context
- Population
- Healthy participants and people with T2D (single-dose study); people with T2D previously treated with basal insulin, aged 40–69 years (multiple-dose study)
- Comparison
- Once-weekly basal insulin Fc (BIF) vs daily insulin glargine
- Outcome
- Safety, tolerability, PK and glucose pharmacodynamics (PD)
Main finding
As reported in the abstract
BIF pharmacokinetics (PK) half-life
≈17 days
Sustained, dose-dependent decrease in fasting blood glucose
5 days or longer
BIF peak-to-trough ratio after last dose at week 6 (steady state)
1.14
Further findings
Single-dose study demographics
- Mean age, T2D (N = 57)
- 58.4 years
- Mean age, healthy (N = 16)
- 35.8 years
- Mean BMI, T2D
- 29.5 kg/m²
- Mean BMI, healthy
- 26.1 kg/m²
- Multiple-dose study participants with T2D
- 33
Safety
Severe hypoglycaemia (single-dose study)
- No severe hypoglycaemia was observed
Hypoglycaemic events (6-week multiple-dose study)
- Rates and duration of BIF hypoglycaemic events were similar to insulin glargine
Tolerability
- BIF was well tolerated
Original publication
Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once‐weekly dosing for the treatment of patients with diabetes. Diabetes Obes Metab. Published 9 January 2023. doi:10.
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