TY - JOUR
T1 - Basal insulin analogues in diabetic pregnancy
T2 - A literature review and baseline results of a randomised, controlled trial in type 1 diabetes
AU - Mathiesen, Elisabeth R.
AU - Damm, Peter
AU - Jovanovic, Lois
AU - Mccance, David R.
AU - Thyregod, Camilla
AU - Jensen, Anders Boisen
AU - Hod, Moshe
PY - 2011/9
Y1 - 2011/9
N2 - As basal insulin analogues are being used off-label, there is a need to evaluate their safety (maternal hypoglycaemia and fetal and perinatal outcomes) and efficacy [haemoglobin A$-{\rm{1c}}$ (HbA$-{\rm{1c}}$), fasting plasma glucose, and maternal weight gain]. The aim of this review is to provide an overview of the current literature concerning basal insulin analogue use in diabetic pregnancy, and to present the design and preliminary, non-validated baseline characteristics of a currently ongoing randomized, controlled, open-label, multicentre, multinational trial comparing insulin detemir with neutral protamine hagedorn insulin, both with insulin aspart, in women with type 1 diabetes planning a pregnancy (n = 306) or are already pregnant (n = 164). Inclusion criteria include type 1 diabetes > 12 months' duration; screening HbA$-{\rm{1c}} \leq 9.0\%$ (women recruited prepregnancy), or pregnant with gestational age 8-12 weeks and HbA$-{\rm{1c}} \leq 8.0\%$ at randomization. At confirmation of pregnancy all subjects must have HbA$-{\rm{1c}} \leq 8.0\%$. Exclusion criteria include impaired hepatic function, cardiac problems, and uncontrolled hypertension. Subjects are randomized to either insulin detemir or neutral protamine hagedorn insulin, both with prandial insulin aspart. The results are expected mid-2011 with full publications expected later this year. Baseline characteristics show that basal insulin analogues are already frequently used in pregnant women with type 1 diabetes. This study will hopefully elucidate the safety and efficacy of the basal insulin analogue detemir in diabetic pregnancy.
AB - As basal insulin analogues are being used off-label, there is a need to evaluate their safety (maternal hypoglycaemia and fetal and perinatal outcomes) and efficacy [haemoglobin A$-{\rm{1c}}$ (HbA$-{\rm{1c}}$), fasting plasma glucose, and maternal weight gain]. The aim of this review is to provide an overview of the current literature concerning basal insulin analogue use in diabetic pregnancy, and to present the design and preliminary, non-validated baseline characteristics of a currently ongoing randomized, controlled, open-label, multicentre, multinational trial comparing insulin detemir with neutral protamine hagedorn insulin, both with insulin aspart, in women with type 1 diabetes planning a pregnancy (n = 306) or are already pregnant (n = 164). Inclusion criteria include type 1 diabetes > 12 months' duration; screening HbA$-{\rm{1c}} \leq 9.0\%$ (women recruited prepregnancy), or pregnant with gestational age 8-12 weeks and HbA$-{\rm{1c}} \leq 8.0\%$ at randomization. At confirmation of pregnancy all subjects must have HbA$-{\rm{1c}} \leq 8.0\%$. Exclusion criteria include impaired hepatic function, cardiac problems, and uncontrolled hypertension. Subjects are randomized to either insulin detemir or neutral protamine hagedorn insulin, both with prandial insulin aspart. The results are expected mid-2011 with full publications expected later this year. Baseline characteristics show that basal insulin analogues are already frequently used in pregnant women with type 1 diabetes. This study will hopefully elucidate the safety and efficacy of the basal insulin analogue detemir in diabetic pregnancy.
KW - Analogue
KW - Detemir
KW - Pregnancy
KW - Type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=80052571870&partnerID=8YFLogxK
U2 - 10.1002/dmrr.1213
DO - 10.1002/dmrr.1213
M3 - סקירה
AN - SCOPUS:80052571870
VL - 27
SP - 543
EP - 551
JO - Diabetes/Metabolism Research and Reviews
JF - Diabetes/Metabolism Research and Reviews
SN - 1520-7552
IS - 6
ER -