title: Premixed insulin aspart 30 (BIAsp 30) versus premixed human insulin 30 (BHI 30) in gestational diabetes mellitus: a randomized open-label controlled study.
abstract: A randomized, open-label, parallel study was conducted to assess the efficacy and safety of premixed insulin aspart 30 (biphasic insulin aspart [BIAsp] 30) in managing gestational diabetes mellitus (GDM). A total of 323 women with GDM registered at a single center in India were randomly assigned to receive 6 U of either BIAsp 30 (Group A) or premixed human insulin (biphasic human insulin [BHI] 30; Group B) in a 1:1 ratio. Subjects performed home glucose monitoring and visited their care provider twice a month. The primary outcome was the degree of neonatal macrosomia (neonatal birth weight >90th percentile). Groups A and B were demographically comparable at study entry. Before labor onset, Groups A and B achieved similar degrees of fasting plasma glucose and postprandial plasma glucose control (92.97 ± 14.44 vs. 95.43 ± 18.96 and 127.59 ± 28.99 vs. 126.98 ± 29.89, respectively; both p = NS). Neonatal macrosomia frequency was 6.3% in Group A and 6.9% in Group B; however, this difference was not statistically significant. By last visit, the required insulin dose was significantly lower for Group A than Group B (19.83 ± 15.75 IU vs. 26.34 ± 23.15 IU, respectively; p = 0.006). BIAsp 30 was noninferior to BHI 30, producing comparable fetal outcomes when administered during pregnancy. Based on final doses, BIAsp 30 may offer greater treat-to-target potential for pregnant women.
authors.affiliation: Diabetes Care and Research Institute, Chennai, Tamilnadu, India.
authors.forename: Vijayam
authors.initials: V
authors.lastname: Balaji
authors.forename: Madhuri S
authors.initials: MS
authors.lastname: Balaji
authors.forename: Cynthia
authors.initials: C
authors.lastname: Alexander
authors.forename: Ashalata
authors.initials: A
authors.lastname: Srinivasan
authors.forename: Sheela R
authors.initials: SR
authors.lastname: Suganthi
authors.forename: Arthi
authors.initials: A
authors.lastname: Thiyagarajah
authors.forename: Veerasamy
authors.initials: V
authors.lastname: Seshiah
mesh_terms: D061265:Biphasic Insulins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001724:Birth Weight / Q000187:drug effects; D001786:Blood Glucose / Q000032:analysis; D015331:Cohort Studies; D016640:Diabetes, Gestational / Q000097:blood / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D005320:Fetal Macrosomia / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007194:India / Q000453:epidemiology; D007231:Infant, Newborn; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D008297:Male; D011247:Pregnancy
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D004338:Drug Combinations; D007004:Hypoglycemic Agents; C575870:biphasic human insulin 30; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart