Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study
Primary result · Mean HbA1c change from baselineResult — go to the resultTreatment difference (pooled BIF) 0.1 % 90% CI −0.1 to 0.3Authors' conclusion
Weekly BIF achieved a similar efficacy compared with degludec despite higher fasting glucose targets in the BIF groups. Higher fasting glucose targets and lower glucose variability might have contributed to lower hypoglycaemia rates for BIF compared with degludec. These findings support continued development of BIF as a once-weekly insulin treatment for people with diabetes.
Study context
- Population
- Adults with T2D previously treated with basal insulin and up to three oral antidiabetic medicines; USA, Puerto Rico and Mexico379 analysed
- Participants
- 399 adults
- Comparison
- Once-weekly Basal insulin Fc (BIF) vs insulin degludec
- BIF-A1n = 135
- BIF-A2n = 132
- Degludecn = 132reference
- Primary endpoint
- Change in HbA1c from baseline to week 32 for BIF; BIF vs degludec with non-inferiority margin 0.40%
- Follow-up
- Week 32
Methodological detailsphase 2, multicentre (44 sites), open-label, comparator-controlled, Enrolment Nov 15, 2018 to Feb 18, 2020
- Phase 2
- Multicentre (44 sites)
- Open-label
- Comparator-controlled
- Enrolment Nov 15, 2018 to Feb 18, 2020
Primary result
Mean HbA1c change from baseline
Treatment difference (pooled BIF)
0.1 %
90% CI −0.1 to 0.3
Change by group
BIF-A1
−0.6
mean · SE 0.1% · %
BIF-A2
−0.6
mean · SE 0.1% · %
Degludec
−0.7
mean · SE 0.1% · %
BIF-A1vs Degludec
treatment difference (pooled BIF) 0.1 % (90% CI −0.1 to 0.3)
As reported in the abstract
Safety
| Outcome | Treatment ratio (CI) | |
|---|---|---|
| Hypoglycaemia (≤3.9 mmol/L) event rate, events per patient per yearBIF-A1vs Degludec | 0.75 (0.61–0.93) | |
| Hypoglycaemia (≤3.9 mmol/L) event rate, events per patient per yearBIF-A2vs Degludec | 0.74 (0.58–0.94) | |
| 0.512Treatment ratio (log scale) |
- Hypoglycaemia (≤3.9 mmol/L) event rate, events per patient per year — Hypoglycaemia event rates in BIF groups lower than degludec
- 25%
Treatment-emergent adverse events
- BIF was well tolerated; TEAEs similar across groups
Original publication
Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol. Published 6 February 2023. doi:10.
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