|
 |
|
|||||||
|
|||||||||
DOI: 10.2337/dc06-1887
© 2007 by the American Diabetes Association
Clinical Care/Education/Nutrition |
Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy
A randomized trial of insulin aspart versus human insulin in 322 pregnant women
1 Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark
2 Department of Endocrinology, Mater Misericordiae University Hospital Dublin, Dublin, Ireland
3 Diabetes Research Group, Kings College School of Medicine, London, U.K.
4 Northern General Hospital, Sheffield, U.K.
5 Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast, U.K.
6 Unidad de Investigacion Diabetes, Hospital Virgen de Valme, Seville, Spain
7 Novo 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
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.
Abbreviations: HI, human insulin • IAsp, insulin aspart • ITT, intention-to-treat
CiteULike 
Del.icio.us 
Digg 
Reddit 
Technorati What's this?
This article has been cited by other articles:
|
|
 |
|
  D. R. Coustan A 40-Year-Old Woman With Diabetes Contemplating Pregnancy After Gastric Bypass Surgery JAMA, June 4, 2008; 299(21): 2550 - 2557. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. R. Nielsen, U. Pedersen-Bjergaard, B. Thorsteinsson, M. Johansen, P. Damm, and E. R. Mathiesen Hypoglycemia in Pregnant Women With Type 1 Diabetes: Predictors and role of metabolic control Diabetes Care, January 1, 2008; 31(1): 9 - 14. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. Jovanovic Point: Oral Hypoglycemic Agents Should Not Be Used to Treat Diabetic Pregnant Women Diabetes Care, November 1, 2007; 30(11): 2976 - 2979. [Full Text] [PDF]
|
|
|
|
|
|
M. Hod and L. Jovanovic Improving Outcomes in Pregnant Women With Type 1 Diabetes Diabetes Care, July 1, 2007; 30(7): e62 - e62. [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| Diabetes | Diabetes Care | Clinical Diabetes | Diabetes Spectrum |