Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes
Primary result · HbA1c change from baselineResult — go to the resultTreatment difference 0.17 % 90% CI 0.01–0.32Authors' conclusion
Once-weekly BIF demonstrated noninferior glycemic control to once-daily degludec (treatment difference: 0.17% favoring degludec) and no difference in hypoglycemia or other safety findings in patients with T1D.
Study context
- Population
- Patients with T1D using MDI; both groups titrated to fasting glucose 80–100 mg/dLrandomized 1:1
- Participants
- 265 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 · 26 weeks
Treatment difference
0.17 %
90% CI 0.01–0.32
P = 0.07
BIFvs Degludec
treatment difference 0.17 % (90% CI 0.01–0.32); P = 0.07
Non-inferiority margin 0.4 as printed, not drawn
As reported in the abstract
Secondary outcomes
Percent TIR (70-180 mg/dL) · week 26 · similar
P = 0.112
CGM fasting glucose · significantly higher with BIF
P = 0.003
Safety
| Outcome | P value |
|---|---|
| CGM-derived hypoglycemia rates over 24 h · treatment periodBIF vs Degludec · level 1; not significantly different | P = 0.960 |
| CGM-derived hypoglycemia rates over 24 h · treatment periodBIF vs Degludec · level 2; not significantly different | P = 0.517 |
Serious adverse events
- Occurrence of serious adverse events similar between BIF and degludec
Original publication
Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes. Diabetes Care. Published 15 March 2023. doi:10.
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