Basal Insulin Fc (BIF) vs Degludec in Type 1 Diabetes Patients Using Multiple Daily Injections
Study design: Phase 2, randomized, parallel, open-label study
Population: 265 patients with type 1 diabetes (T1D) using multiple daily injections
- Number of patients studied: 265
- Inclusion criteria: Patients with T1D
- Exclusion criteria: Not provided
Interventions
- Experimental group: BIF once weekly
- Control group: Degludec once daily
Primary outcome: HbA1c change from baseline to week 26
Secondary/ Safety outcomes
| Safety Outcomes | BIF once weekly vs. Degludec |
|---|---|
| HbA1c change from baseline to week 26 | Noninferior |
| Percent time in range (TIR) (70-180 mg/dL) | Similar at week 26 (BIF: 56.1%; Degludec: 58.9%) |
| Continuous glucose monitoring (CGM) fasting glucose (FG) level | Significantly higher for BIF (158.8 mg/dL) compared to degludec (143.2 mg/dL) |
| Rate of hypoglycemia (CGM-derived) | Not statistically significantly different for BIF and degludec over 24h |
| Occurrence of serious adverse events | Similar between BIF and degludec groups |
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.
Christof M. Kazda, Juliana M. Bue-Valleskey, Jenny Chien, Qianyi Zhang, Emmanuel Chigutsa, William Landschulz, Paula Wullenweber, Axel Haupt, Dominik Dahl; 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 1 May 2023; 46 (5): 1052–1059.