Levemir® is the first FDA-approved basal insulin analog with Pregnancy Category B classification.
Levemir® — the first basal insulin analog with Pregnancy Category B classification.1
In a randomized, controlled clinical trial1:
- Pregnant women with type 1 diabetes (n=310) were treated with either Levemir® (n=152) or NPH insulin (n=158) in a basal-bolus regimena
- Women were randomized either as pregnant or planning pregnancy; those who where randomized as pregnant were between weeks 8 and 12 of gestationb
- Approximately one-half of the study participants in each arm were randomized as pregnant and were exposed to NPH insulin or other insulins prior to conception and in the first 8 weeks of gestation
- According to pretrial insulin regimen:
- Levemir® was administered once or twice daily
- NPH was administered once, twice, or 3 times a day
Comparable A1C reductions vs NPH insulin1,2
Reductions in A1C during gestation
An open-label, randomized, parallel-group, multinational study in women with type 1 diabetes who were on insulin for at least 12 months before randomization and who were planning to become pregnant or already pregnant at gestational weeks (GWs) 8 to 12. Patients could enroll in the study with intention to become pregnant. Patients were withdrawn from the trial if they did not become pregnant within 1 year. Patients were separated at randomization as pregnant and nonpregnant and all were required to have A1C ≤8% at confirmation of pregnancy. Patients were randomized 1:1 to Levemir® (n=152) or NPH insulin (n=158). Both groups used NovoLog® (insulin aspart injection) 100 U/mL as mealtime insulin. Approximately 50% of the women also received Levemir® or NPH insulin prior to conception and in the first 8 weeks of gestation. Regimen was followed from randomization until termination/6 weeks postdelivery.2
Adapted from Mathiesen et al, 2012.2
Similar rates of hypoglycemia vs NPH insulin1,c
Rates of severe hypoglycemia
- Minor hypoglycemia rates were comparable (104.4 events per patient/year for the Levemir® group, 101.0 events per patient/year for the NPH insulin group)
aBoth groups used NovoLog® (insulin aspart injection) 100 U/mL as mealtime insulin.
bPatients were withdrawn from the trial if they did not become pregnant within 1 year.
cNon-severe=PG <56 mg/dL (BG <50 mg/dL) with or without symptoms (patient able to self-treat). Severe=PG <56 mg/dL (BG <50 mg/dL) with symptoms consistent with hypoglycemia or reversal of symptoms after food intake, glucagon, or intravenous glucose (patient unable to self-treat).
“No difference in pregnancy outcomes or the health of the fetus and newborn were seen with Levemir® use”1