Gestational diabetes & diabetes in pregnancy
Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open‑label, multinational, randomised, controlled, non-inferiority trial
Errata to this article were published (Lancet Diabetes Endocrinol, May 2023 ↗ · Aug 2023 ↗)
Authors' conclusion
In pregnant women with type 1 diabetes, degludec was found to be non-inferior to detemir.
Study context
- Population
- Women aged ≥18 years with T1D at gestational age 8 weeks (+0 days) to 13 weeks (+6 days) or planning pregnancy296 screened
- Participants
- 225 women
- Comparison
- Insulin degludec vs insulin detemir, both with insulin aspart
- Degludecn = 111
- Detemirn = 114reference
- Primary endpoint
- Last planned HbA1c measurement before delivery (non-inferiority margin 0.4%)
- Follow-up
- Before delivery
Methodological detailsopen-label, multinational, non-inferiority, 56 sites in 14 countries
- Open-label
- Multinational
- Non-inferiority
- 56 sites in 14 countries
Primary result
As reported in the abstract
Last planned HbA1c before delivery
Degludec vs DetemirEstimated treatment difference, % (95% CI)P value
Non-inferiority margin 0.4%; non-inferiority confirmed
−0.11(−0.31 to 0.08)
P < 0.0001for non-inferiorityDegludec vs DetemirEstimated treatment difference, mmol/mol (95% CI)
Last planned HbA1c before delivery
−1.2(−3.4 to 0.9)
Non-inferiority margin 0.4 as printed, not drawn
Secondary outcomes
HbA1c at pregnancy baseline
Safety
- Compared with detemir, no additional safety issues were observed with degludec
Original publication
Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open‑label, multinational, randomised, controlled, non-inferiority trial. Lancet Diabetes Endocrinol. Published 6 January 2023. doi:10.
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