【文摘发布】1型糖尿病妊娠期的血糖控制和低血糖：一项比较322例孕妇使用诺和锐与人胰岛素的随机试验
发布于 2007-04-13 · 浏览 1887 · IP 北京北京
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RESOURCE:Diabetes Care 30:771-776, 2007
DOI: 10.2337/dc06-1887
TITLE:Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy
A randomized trial of insulin aspart versus human insulin in 322 pregnant women
AUTHOR:Elisabeth R. Mathiesen, MD, DMSC, Brendan Kinsley, MD, FRCPI, Stephanie A. Amiel, MD, FRCP, Simon Heller, MD, FRCP, David McCance, MD, Santiago Duran, MD, Shannon Bellaire, MSC, Anne Raben, PHD on behalf of the Insulin Aspart Pregnancy Study Group
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.
DOI: 10.2337/dc06-1887
TITLE:Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy
A randomized trial of insulin aspart versus human insulin in 322 pregnant women
AUTHOR:Elisabeth R. Mathiesen, MD, DMSC, Brendan Kinsley, MD, FRCPI, Stephanie A. Amiel, MD, FRCP, Simon Heller, MD, FRCP, David McCance, MD, Santiago Duran, MD, Shannon Bellaire, MSC, Anne Raben, PHD on behalf of the Insulin Aspart Pregnancy Study Group
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.
最后编辑于 2007-04-14 · 浏览 1887
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