Insulin degludec noninferior to insulin detemir for pregnant women with type 1 diabetes
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Key Takeaways:
- Women with type 1 diabetes who used insulin degludec during pregnancy had similar HbA1c and glucose profile as those who used insulin detemir.
- Safety profile was similar for the two insulin types.
Pregnant women with type 1 diabetes who were treated with insulin degludec had a similar reduction in HbA1c as those using insulin detemir, according to findings published in The Lancet Diabetes & Endocrinology.
“The use of degludec in pregnant women with type 1 diabetes resulted in noninferior glycemic control relative to detemir with respect to HbA1c measurements, with no additional safety issues identified,” Elisabeth R. Mathiesen, PhD, professor of endocrinology, chief physician and associate professor in the faculty of health science, University of Copenhagen, Rigshospitalet, Denmark, and head of diabetes treatment at the Copenhagen Centre for Pregnant Women with Diabetes, and colleagues wrote. “The findings are reassuring, since detemir has been well studied and is considered effective with a good safety profile in pregnant populations.”
Researchers conducted an open-label, parallel-group noninferiority trial at 56 hospitals in 14 countries from Nov. 22, 2017, to Dec. 17, 2020. Women with type 1 diabetes for at least 1 year who were being treated with multiple daily subcutaneous insulin injections or continuous subcutaneous insulin infusion for at least 90 days and had an HbA1c at baseline of 8% or less were included. Participants had to be pregnant or planning to become pregnant within 12 months to be eligible. The cohort was randomly assigned, 1:1, to 100 U/mL of insulin degludec (Tresiba, Novo Nordisk) once daily or insulin detemir (Levemir, Novo Nordisk) once or twice daily alongside 100 U/mL of mealtime insulin aspart two to four times per day. Women who were pregnant at baseline received the trial drug from randomization until 28 days after delivery. Women who were not pregnant at baseline received the trial drug prior to conception and continued it until 28 days after delivery. Follow-up telephone calls were conducted weekly, and site visits took place every 4 weeks during conception and pregnancy. Follow-ups also took place 28 days after delivery and 7 and 30 days after the end of treatment. The primary endpoint was the last HbA1c measurement before delivery. Researchers also compared fasting and postprandial glucose, adverse events and neonatal endpoints between the groups.
There were 188 women who became pregnant during the trial, including 92 in the insulin degludec group and 96 in the insulin detemir group. Insulin degludec was noninferior to insulin detemir, with the insulin degludec group achieving a final HbA1c before delivery of 6.2% vs. 6.3% for women receiving insulin detemir (P for noninferiority < .0001). The percentage of women achieving an HbA1c of 6% or less in the final measurement prior to delivery was 43% for insulin degludec and 37% for insulin detemir. Additionally, 69% of the insulin degludec group and 63% of the insulin detemir group achieved an HbA1c of 6.5% or less in the final measurement prior to delivery.
Both groups had similar changes in fasting plasma glucose, postprandial glucose and mean total daily insulin dose from baseline until the final visit prior to delivery. There was no difference between the groups for hypoglycemia events, maternal adverse events or serious adverse events. The odds for preeclampsia were not different between the groups.
Both groups had similar proportions of women with early loss of pregnancy and major abnormalities. The odds for preterm deliveries were similar. There was no difference in mean birth weight or the percentage of infants born large for gestational age, the researchers wrote. The percentage of infants with neonatal hypoglycemia in the first 24 hours after birth and with adverse events after delivery was similar between the groups. No clinically relevant differences were observed for any vital signs in participating women from baseline until the end of treatment.
“Overall, this trial provides evidence regarding the efficacy and safety of degludec both in women who were pregnant and women planning to become pregnant,” the researchers wrote. “Regarding those planning to become pregnant, the study helps to highlight the importance of preconception care, which should be provided by means of a multidisciplinary approach, to help ensure adoption of the best insulin and management regimen before pregnancy.”
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