Premixed insulin aspart 30 (Biasp 30) vs. premixed human insulin 30 (BHI 30) in gestational diabetes mellitus--a pilot study.
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).


CONCLUSIONS
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.
Balaji
V
V
Dr. V. Seshiah Diabetes Research Institute, Dr. Balaji Diabetes Care Centre, Chennai 600029, Tamilnadu, India.
Balaji
Madhuri S
MS
Alexander
Cynthia
C
Ashalata
S
S
Sheela Suganthi
R
R
Suresh
S
S
Seshiah
V
V
D000328:Adult; D061265:Biphasic Insulins; D001724:Birth Weight; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002851:Chromatography, High Pressure Liquid; D016640:Diabetes, Gestational / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007231:Infant, Newborn; D007279:Injections, Subcutaneous; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061267:Insulin Aspart; D007336:Insulin, Isophane; D010865:Pilot Projects; D011247:Pregnancy; D011256:Pregnancy Outcome; D016896:Treatment Outcome; D055815:Young Adult
D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D007336:Insulin, Isophane; C557564:insulin aspart, insulin aspart protamine drug combination 30:70