Objective: Benefits of once-daily insulin degludec/aspart (IDegAsp) compared with basal insulin in patients with type 2 diabetes (T2D) have not been established. As we have observed that a low ratio of fasting plasma glucose (FPG) to mean glucose was associated with superior response to IDegAsp by a retrospective study, we aimed to confirm it by a prospective design.

Methods: A randomized, open-label, cross-over trial was conducted in patients on a basal insulin therapy with FPG lower than predicted FPG (=12.6 x HbA1c (%) + 30, drawn from our previous study). Participants were assigned 1:1 ratio to IDegAsp or insulin glargine (IGlar) arm. After 20 weeks, the treatments were exchanged for the next 20 weeks. The primary endpoint was treatment difference of HbA1c changes from the baseline. Additionally, self-reported hypoglycemic events were collected, and a professional CGM was applied for 1 week prior to completion of each treatment.

Results: The study included 55 subjects (male 40 %, age 64.6 ± 9.5 years, FPG 102.6 ± 19.5 mg/dL, HbA1c 8.3 ± 0.6 %). After 20 weeks, the HbA1c significantly decreased to 7.8 ± 0.8 % by IDegAsp (0.40 ± 0.17 U/kg) and to 8.0 ± 0.7 % by IGlar (0.39 ± 0.18 U/kg). The mean estimated treatment difference of changes in HbA1c was not statistically significant (-0.22% point, 95% CI [-0.52, 0.08], p=0.078). In the CGM analyses, IDegAsp significantly reduced glucose levels after breakfast and before lunch, compared to IGlar. TIR, TBR, and hypoglycemic events were not significantly different between the treatments.

Conclusion: Compared to basal insulin, once-daily IDegAsp demonstrated a marginal benefit in reducing HbA1c in patients with lower FPG than predicted by their HbA1c, though the glycemic excursions after breakfast were significantly improved. More indices would be needed to tell those expected to have significant benefits by switching from basal insulin to IDegAsp. UTN#: U1111-1241-6269

Disclosure

E. Hong: None. H. Jang: None. S. Lee: None. Y. Yang: None. S. Kwak: Employee; SNUH Venture. K. Park: None. H. Jang: Consultant; Novo Nordisk. H. Jung: Research Support; Novo Nordisk.

Funding

Novo Nordisk, NRF (2022R1A2C2004570)

© 2024 by the American Diabetes Association
2024
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.