On January 30, 2007, the FDA upgraded NovoLog (a fast-acting insulin analog from Novo Nordisk) from Category C to Category B, thereby indicating that NovoLog is safe and effective for pregnant women with type 1 and their unborn children.
The upgrade was based on the largest ever randomized controlled trial of an insulin analog in pregnant women with type 1. The study, conducted at 63 sites in 18 countries, compared the safety and efficacy of NovoLog versus human regular insulin (HRI) in 322 type 1 pregnant women. A1Cs and hypoglycemia were comparable between the two insulins. NovoLog showed improved outcomes for mother and child in terms of fewer preterm deliveries, reduced risk of neonatal hypoglycemia, and rates of major hypoglycemia. Risks to the fetus were comparable between the two insulins.