Titre du document / Document title

Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy : A randomized trial of insulin aspart versus human insulin in 322 pregnant women

Auteur(s) / Author(s)

The Insulin Aspart Pregnancy Study Group
MATHIESEN Elisabeth R. ⁽¹⁾ ; KINSLEY Brendan ⁽²⁾ ; AMIEL Stephanie A. ⁽³⁾ ; HELLER Simon ⁽⁴⁾ ; MCCANCE David ⁽⁵⁾ ; DURAN Santiago ⁽⁶⁾ ; BELLAIRE Shannon ⁽⁷⁾ ; RABEN Anne ⁽⁷⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Department of Endocrinology, Rigshospitalet, Copenhagen, DANEMARK
⁽²⁾ Department of En docrinology, Mater Misericordiae University Hospital Dublin, Dublin, IRLANDE
⁽³⁾ Diabetes Research Group, Kings College School of Medicine, London, ROYAUME-UNI
⁽⁴⁾ Northem General Hospital, Sheffield, ROYAUME-UNI
⁽⁵⁾ Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast, ROYAUME-UNI
⁽⁶⁾ Unidad de Investigacion Diabetes, Hospital Virgen de Valme, Seville, ESPAGNE
⁽⁷⁾ Novo Nordisk, Copenhagen, DANEMARK

Résumé / 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.

Revue / Journal Title

Diabetes care   ISSN 0149-5992   CODEN DICAD2 

Source / Source

2007, vol. 30, n^o4, pp. 771-776 [6 page(s) (article)] (39 ref.)

Langue / Language

Anglais

Editeur / Publisher

American Diabetes Association, Alexandria, VA, ETATS-UNIS  (1978) (Revue)

Mots-clés anglais / English Keywords

Immunopathology ; Autoimmune disease ; Endocrinopathy ; Metabolic diseases ; Woman ; Adult ; Human ; Comparative study ; Insulin aspart ; Randomization ; Clinical trial ; Insulin human ; Female ; Pregnancy ; Type 1 diabetes ; Glycemia ; Mother ; Hypoglycemia ;

Mots-clés français / French Keywords

Immunopathologie ; Maladie autoimmune ; Endocrinopathie ; Métabolisme pathologie ; Femme ; Adulte ; Homme ; Etude comparative ; Insuline asparte ; Randomisation ; Essai clinique ; Insuline humaine ; Femelle ; Gestation ; Diabète type 1 ; Glycémie ; Mère ; Hypoglycémie ;

Mots-clés espagnols / Spanish Keywords

Inmunopatología ; Enfermedad autoinmune ; Endocrinopatía ; Metabolismo patología ; Mujer ; Adulto ; Hombre ; Estudio comparativo ; Insulina asparta ; Aleatorización ; Ensayo clínico ; Insulina humana ; Hembra ; Gestación ; Diabetes de tipo 1 ; Glucemia ; Madre ; Hipoglicemia ;

Localisation / Location

INIST-CNRS, Cote INIST : 18054, 35400014351614.0010