1056-P: Reported Pregnancy Outcomes with Insulin Glargine 100 U/mL (Gla-100) and 300 U/mL (Gla-300) : Post-Marketing Survey of Pharmacovigilance Data

Abstract

Background: Good metabolic control during pregnancy is crucial for people with diabetes to prevent adverse events associated with hyperglycemia. Gla-300, a long-acting basal insulin (BI) analog, provides similar glycemic control and less hypoglycemia versus the first-generation BI Gla-100. We examined real-life safety of insulin glargine use in pregnancy. Methods: Cumulative searches of the Sanofi global pharmacovigilance database for Gla-100/Gla-300 exposures in pregnancy were performed using Medical Dictionary for Regulatory Activities terms, from database initiation to March 9, 2021. Results: Searches found 4936 (2370 solicited, 2566 unsolicited; 71 countries) exposures to Gla-100 and 246 (66 solicited, 180 unsolicited; 44 countries) for Gla-300 (Table) . Cumulative exposure was 89 million and 7.9 million person-years for Gla-100 and Gla-300, respectively. Congenital, familial, and genetic anomalies were rare (2.6% Gla-100; 2.0% Gla-300) , in line with general population rates (3-5%) . Spontaneous abortion rates were low (3.0% Gla-100; 2.8% Gla-300) , which is also in line with the general population (˜10%) . Conclusion: Rates of congenital anomalies and spontaneous abortions for Gla-100 and Gla-300 were consistent with the general population. The results indicate no safety issues with insulin glargine use during pregnancy. Disclosure J.Westerbacka: Employee; Sanofi, Stock/Shareholder; Sanofi. C.Bassole: Employee; Sanofi. M.Duverne: Employee; Sanofi. Z.Doder: None. H.Schoepper: None. Funding Sanofi