Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy
A randomized trial of insulin aspart versus human insulin in 322 pregnant women
- Elisabeth R. Mathiesen, MD, DMSC1,
- Brendan Kinsley, MD, FRCPI2,
- Stephanie A. Amiel, MD, FRCP3,
- Simon Heller, MD, FRCP4,
- David McCance, MD5,
- Santiago Duran, MD6,
- Shannon Bellaire, MSC7,
- Anne Raben, PHD7 and
- on behalf of the Insulin Aspart Pregnancy Study Group
- 1Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark
- 2Department of Endocrinology, Mater Misericordiae University Hospital Dublin, Dublin, Ireland
- 3Diabetes Research Group, Kings College School of Medicine, London, U.K.
- 4Northern General Hospital, Sheffield, U.K.
- 5Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast, U.K.
- 6Unidad de Investigacion Diabetes, Hospital Virgen de Valme, Seville, Spain
- 7Novo Nordisk, Copenhagen, Denmark
- Address correspondence and reprint requests to Elisabeth R. Mathiesen, Copenhagen Centre for Pregnant Women With Diabetes, Department of Endocrinology 2132, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. E-mail: em{at}rh.dk
Abstract
OBJECTIVE—To assess the safety and efficacy of insulin aspart (IAsp) versus regular human insulin (HI) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes.
RESEARCH DESIGN AND METHODS—Subjects (n = 322) who were pregnant or planning pregnancy were randomized to IAsp or HI as meal-time insulin in an open-label, parallel-group, multicenter study. Subjects had A1C ≤8% at confirmation of pregnancy. Insulin doses were titrated toward predefined glucose targets and A1C <6.5%. Outcomes assessed included risk of major maternal hypoglycemia, A1C, plasma glucose profiles, and maternal safety outcomes.
RESULTS—Major hypoglycemia occurred at a rate of 1.4 vs. 2.1 episodes/year exposure with IAsp and HI, respectively (relative risk 0.720 [95% CI 0.36–1.46]). Risk of major/major nocturnal hypoglycemia was 52% (RR 0.48 [0.20–1.143]; P = NS) lower with IAsp compared with HI. A1C was comparable with human insulin in second (IAsp-HI −0.04 [−0.18 to 0.11]) and third (−0.08 [−0.23 to 0.06]) trimesters. A total of 80% of subjects achieved an A1C ≤6.5%. At the end of first and third trimesters, average postprandial plasma glucose increments were significantly lower with IAsp than HI (P = 0.003 and P = 0.044, respectively), as were mean plasma glucose levels 90 min after breakfast (P = 0.044 and P = 0.001, respectively). Maternal safety profiles and pregnancy outcomes were similar between treatments.
CONCLUSIONS—IAsp is at least as safe and effective as HI when used in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes and may potentially offer some benefits in terms of postprandial glucose control and preventing severe hypoglycemia.
Footnotes
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Clinical trial reg. no. NCT00365170, clinicaltrials.gov.
E.R.M. is a member of the scientific advisory panel for this study and has received monetary compensation for this consulting work. S.A.A. has served on advisory panels for Pfizer, Sanofi-Aventis, Novartis, MSD, Eli Lilly U.K., and Amylin. S.H. has served on advisory boards for, has received research funds from, and has given lectures sponsored by Novo Nordisk.
Additional information for this article can be found in an online appendix at http://dx.doi.org/10.2337/dc06-1887.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
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- Accepted December 28, 2006.
- Received September 8, 2006.
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