Sénat MV, et al. - Researchers performed comparison of oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. The findings do not establish noninferiority of glyburide for prevention of perinatal complications of gestational diabetes. These findings do not justify the use of glyburide as a first-line treatment. Thus no justification in favor of using glyburide as a first-line treatment could be made.

Methods

• Researchers conducted the Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France.
• They included 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation.
• Random assignment of women who required pharmacologic treatment after 10 days of dietary intervention to receive glyburide (n=460) or insulin (n=454) was performed.
• In this study, the starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d.
• The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations.
• A composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia was the primary outcome.
• Based on a 1-sided 97.5% confidence interval, the noninferiority margin was set at 7%.

Results

• Researchers randomized 914 patients in this trial (mean age, 32.8 [SD, 5.2] years); 98% of these completed the trial.
• In the glyburide and insulin groups, 367 and 442 women and their neonates were analyzed, respectively, in a per-protocol analysis,.
• In the glyburide group, the frequency of the primary outcome was 27.6% and in the insulin group, was 23.4%; a difference of 4.2% (1-sided 97.5% CI, -∞ to 10.5%; P=.19).