Abstract | OBJECTIVE: 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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Authors | Elisabeth R Mathiesen, Moshe Hod, Marina Ivanisevic, Santiago Duran Garcia, Lise Brøndsted, Lois Jovanovic, Peter Damm, David R McCance, Detemir in Pregnancy Study Group |
Journal | Diabetes care
(Diabetes Care)
Vol. 35
Issue 10
Pg. 2012-7
(Oct 2012)
ISSN: 1935-5548 [Electronic] United States |
PMID | 22851598
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Insulin, Long-Acting
- hemoglobin A1c protein, human
- Insulin Detemir
- Insulin, Isophane
- Insulin Aspart
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Topics |
- Adult
- Blood Glucose
(metabolism)
- Diabetes Mellitus, Type 1
(drug therapy)
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Insulin Aspart
(therapeutic use)
- Insulin Detemir
- Insulin, Isophane
(therapeutic use)
- Insulin, Long-Acting
(therapeutic use)
- Pregnancy
- Pregnancy in Diabetics
(drug therapy)
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