OBJECTIVE: The objective of the study was to compare premixed insulin aspart 30 (BIAsp 30) vs premixed human insulin 30 (BHI 30) on efficacy, safety, fetal and perinatal outcomes in pregnancies associated with gestational diabetes mellitus [GDM]. This was the first randomized study to use pre mixed insulin analogue [BIAsp] in GDM. METHODS: The study population consisted of 76 GDM women assigned to BIAsp 30 (group A) and an equal number to BHI 30 (group B). RESULTS: There was no statistically significant difference between the age, BMI, gestational weeks and glycemic level at entry between the group A and group B women (p > 0.05). There was no statistical difference between the two groups in glycemic control or insulin dose (p > 0.05) before confinement. The frequency of birth weight of new born above 90 percentile was 6.8% in Group 1 and 9.2% in Group 2. The proportion of macrosomia was higher in Group 2 when compared to Group 1, however the difference was not statistically significant (P = 0.819). CONCLUSION:BIAsp was safe during pregnancy and pregnant women found it convenient due to meal time dosing. Fetal outcome using BIAsp was also comparable with BHI 30.
RCT Entities:
OBJECTIVE: The objective of the study was to compare premixed insulin aspart 30 (BIAsp 30) vs premixed humaninsulin 30 (BHI 30) on efficacy, safety, fetal and perinatal outcomes in pregnancies associated with gestational diabetes mellitus [GDM]. This was the first randomized study to use pre mixed insulin analogue [BIAsp] in GDM. METHODS: The study population consisted of 76 GDM women assigned to BIAsp 30 (group A) and an equal number to BHI 30 (group B). RESULTS: There was no statistically significant difference between the age, BMI, gestational weeks and glycemic level at entry between the group A and group B women (p > 0.05). There was no statistical difference between the two groups in glycemic control or insulin dose (p > 0.05) before confinement. The frequency of birth weight of new born above 90 percentile was 6.8% in Group 1 and 9.2% in Group 2. The proportion of macrosomia was higher in Group 2 when compared to Group 1, however the difference was not statistically significant (P = 0.819). CONCLUSION: BIAsp was safe during pregnancy and pregnant women found it convenient due to meal time dosing. Fetal outcome using BIAsp was also comparable with BHI 30.
Authors: Debbie A Lawlor; Jane West; Lesley Fairley; Scott M Nelson; Raj S Bhopal; Derek Tuffnell; Dilys J Freeman; John Wright; Donald C Whitelaw; Naveed Sattar Journal: Diabetologia Date: 2014-10-03 Impact factor: 10.122