1. Insulin Detemir versus Glyburide in Women with
Gestational Diabetes Mellitus
Ronit Koren1,3 MD, Eran Ashwal2 MD, Moshe Hod2,3 MD, Yoel Toledano2 MD
1. Institute of Endocrinology, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel
2. Division of Maternal Fetal Medicine, Helen Schneider Women’s Hospital, Rabin Medical Center, 3. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Introduction
Results
A total of 91 patients with GDM were enrolled. Glyburide and IDet treatments were administered in 62 and 29 patients, respectively.
Good glycemic control rates were comparable in both groups. However, hypoglycemic episodes were reported only in the glyburide group. (19.4% vs. 0%, p=0.01). Only one event of severe hypoglycemia was recorded in the glyburide group.
In matched t-test, maternal weight gain during pregnancy was significantly increased among women in the glyburide group (8.8±5.1 p<0.001) compared to the IDet group (2.1±19.9 p=0.71).
One stillbirth was reported in the glyburide group. The rate of composite adverse neonatal outcome was significantly lower in the IDet vs. glyburide group (26.9 vs. 43.5%, p=0.04). However, in a multivariate analysis, this difference was not significant.
Few studies have examined the efficacy and safety of Insulin Detemir (IDet) during pregnancy despite its increasing use in this population (1-3).
The aim of this study was to evaluate the safety, efficacy and pregnancy outcomes of IDet vs. glyburide treatment in women with gestational diabetes mellitus (GDM).
Materials and Methods
A retrospective cohort study of women with GDM who were treated with either glyburide or IDet in a university-affiliated tertiary hospital.
Treatment modality was determined according to physician preferences. Composite adverse neonatal outcome was defined as any: birth weight >90th percentile or ≥4000g, shoulder dystocia, clavicular fracture, hypoglycemia, jaundice or stillbirth. Composite adverse maternal outcome was defined as post-partum hemorrhage (PPH), uterine revision, need for blood transfusion, grade 3 or 4 perineal tears, maternal hypoglycemia or severe hypoglycemia.
Student's t-test and the Mann-Whitney U test were used to compare continuous variables, whereas chi-square and Fisher's exact tests were utilized for categorical variables. Multivariable logistic regression analysis was used to adjust the risk for neonatal and maternal composite adverse outcomes.
Baseline characteristics in women with GDM administered IDet vs. glyburide
IDet
N=29
Glyburide
N=62
p value
Maternal Age (years)
33.8±4.7
33.1±4.0 NS
Pregestational BMI
31.5±8.4
29.0±5.9
Previous GDM
6 (20.7)
19 (30.6)
Previous macrosomia
4 (13.8)
8 (12.9)
Smoking
3 (10.3)
3 (4.8)
Family history of diabetes
12 (41.4)
25 (40.3)
Maternal and neonatal outcomes in women administered IDet vs. glyburide:
IDet, insulin detemir; BMI, body mass index; NS, non-significant; values are presented as mean±SD or n (%)
IDet
N=29
Glyburide
N=62
p value
Maternal hypoglycemia (<60 mg/dL)
0 (0)
12 (19.4)
0.01
Severe maternal hypoglycemia
1 (1.6) NS
Weight gain during pregnancy (kg)
2.1±19.9
8.8±5.1
Birthweight >4,000 gm
1 (3.4)
LGA
4 (13.8)
16 (25.8)
Adverse perinatal outcome associated with Idet vs. glyburide:
IDet, insulin detemir; NS, non-significant; values are presented as mean±SD or n (%)
Conclusions
To the best of our knowledge, this is the first study on IDet treatment in patients with GDM. By our preliminary study, IDet is a viable treatment option in women with GDM.
Further large prospective studies are needed to determine the efficacy and safety of IDet in GDM patients.
References
1. Hod M, Mathiesen ER, Jovanovic L, McCance DR, Ivanisevic M, Duran-Garcia S, Brondsted L, Nazeri A, Damm P. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine hagedorn in type 1 diabetes. The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstet. 2014;27:7-13
2. Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR, Detemir in Pregnancy Study G. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with nph insulin in 310 pregnant women with type 1 diabetes. Diabetes care. 2012;35:
3. Mello G, Biagioni S, Ottanelli S, Nardini C, Tredici Z, Serena C, Marchi L, Mecacci F. Continuous subcutaneous insulin infusion (csii) versus multiple daily injections (mdi) of rapid-acting insulin analogues and detemir in type 1 diabetic (t1d) pregnant women. The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstet. 2014:1-6