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Randomized Controlled Trial
. 2012 Oct;35(10):2012-7.
doi: 10.2337/dc11-2264. Epub 2012 Jul 30.

Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes

Elisabeth R Mathiesen  1 , Moshe Hod, Marina Ivanisevic, Santiago Duran Garcia, Lise Brøndsted, Lois Jovanovic, Peter Damm, David R McCance; Detemir in Pregnancy Study Group
Affiliations
Randomized Controlled Trial

Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes

Elisabeth R Mathiesen et al. Diabetes Care. 2012 Oct.

Abstract

Objective: This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes.

Research design and methods: Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8-12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors and covariates into account.

Results: A total of 310 type 1 diabetic women were randomized and exposed to IDet (n = 152) or NPH (n = 158) up to 12 months before pregnancy (48%) or during pregnancy at 8-12 weeks (52%). The estimated A1C at 36 GWs was 6.27% for IDet and 6.33% for NPH in the full analysis set (FAS). IDet was declared noninferior to NPH (FAS, -0.06% [95% CI -0.21 to 0.08]; per protocol, -0.15% [-0.34 to 0.04]). Fasting plasma glucose (FPG) was significantly lower with IDet versus NPH at both 24 GWs (96.8 vs. 113.8 mg/dL, P = 0.012) and 36 GWs (85.7 vs. 97.4 mg/dL, P = 0.017). Major and minor hypoglycemia rates during pregnancy were similar between groups.

Conclusions: Treatment with IDet resulted in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin. Rates of hypoglycemia were comparable.

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Figures

Figure 1
Figure 1
Mean A1C (%) in subjects randomized before pregnancy (A) or during early pregnancy (B). Mean FPG (mmol/L) in subjects randomized before pregnancy (C) or during early pregnancy (D). All values are mean ± SEM. Detemir, solid line; NPH, dotted line.
Figure 2
Figure 2
Mean PG profile at 14, 24, and 36 GWs in subjects randomized before pregnancy or randomized in early pregnancy by pregnancy status at randomization. A: Mean PG profile in subjects randomized before pregnancy in GW 14. B: Mean PG profile in subjects randomized in early pregnancy at GW 14. C: Mean PG profile in subjects randomized before pregnancy at GW 24. D: Mean PG profile in subjects randomized in early pregnancy at GW 24. E: Mean PG profile in subjects randomized before pregnancy at GW 36. F: Mean PG profile in subjects randomized in early pregnancy at GW 36. BB, before breakfast; BD, before dinner; BL, before lunch. Detemir, circle + solid line; NPH, square + dotted line.
See this image and copyright information in PMC

Comment in

References

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