Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial
Primary result · HbA1c change from baselineResult — go to the resultTreatment difference 0.06 % 90% CI −0.11 to 0.24Authors' conclusion
Once-weekly BIF achieved excellent glycemic control similar to degludec, with no concerning hypoglycemia or other safety findings.
Study context
- Population
- Insulin-naive patients with T2D previously treated with oral antihyperglycemic medicationsrandomized 1:1
- Participants
- 278 patients
- Comparison
- Once-weekly Basal insulin Fc (BIF) vs once-daily degludec
- Primary endpoint
- HbA1c change from baseline (noninferiority margin 0.4%)
- Follow-up
- Week 26
Methodological detailsphase 2, parallel, open-label, noninferiority
- Phase 2
- Parallel
- Open-label
- Noninferiority
Primary result
HbA1c change from baseline
Treatment difference
0.06 %
90% CI −0.11 to 0.24
P = 0.56
BIFvs Degludec
treatment difference 0.06 % (90% CI −0.11 to 0.24); P = 0.56
As reported in the abstract
Secondary outcomes
| Outcome | Between-treatment difference (mg/dL) (90% CI) | P value | |
|---|---|---|---|
| FBG · week 26 | 4.7 (0.1–9.3) | P = 0.09 | |
| −50510Difference, mg/dL (linear scale) |
Fasting blood glucose (FBG) · week 26
- Both BIF and degludec led to significant reductions in FBG from baseline
Safety
Level 2 hypoglycemia rate · not significantly different
P = 0.64
Severe hypoglycemia
- No severe hypoglycemia
Treatment-emergent adverse events
- Occurrence of TEAEs similar between BIF and degludec
Original publication
Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. Diabetes Care. Published 21 March 2023. doi:10.
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