IDF21-0195 Reported pregnancy outcomes with insulin glargine 300 U/mL: a post-marketing survey of pharmacovigilance data

Abstract

Background: It is essential for people with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia. To attain blood glucose control during pregnancy, insulin glargine and other basal insulins are treatment options. Insulin glargine 300 U/mL (Gla-300) is a second-generation basal insulin analogue that has been shown to provide similar glycaemic control with less hypoglycaemia versus the first-generation basal insulin analogue, insulin glargine 100 U/mL. However, there are currently no randomised controlled trials specifically designed to investigate the use of Gla-300 during pregnancy. Aim: The present analysis aims to examine the safety of Gla-300 use in women with diabetes during pregnancy in real-life practice, using post-marketing pharmacovigilance data. Method: Using Medical Dictionary for Regulatory Activities (MedDRA) terms, a cumulative search of Sanofi’s global pharmacovigilance database was performed to identify pregnancy outcomes during Gla-300 use, up until 9 March 2021. Results: Post-marketing searches identified 246 cases for analysis (66 solicited, 180 unsolicited) (Table) from 44 countries. Cumulative exposure to Gla-300 was 7.9 million person-years. Reporting rates for adverse events of specific interest were 31.1/1,000,000 person-years. Congenital, familial, and genetic anomalies were rare with Gla-300 (5, 2.0%: one cardiac, one genito-urinary, one musculoskeletal and connective tissues, one respiratory, and one gastrointestinal tract disorder); this is consistent with the rate of birth defects reported for the general population, which is ∼3–5% of all live births. Spontaneous abortions were also rare (7, 2.8%), consistent with miscarriage rates observed in the general population (≥∼10%). Table.Tabled 1MedDRA search termNumber of events (%)a,bReporting ratec.d,e (events per 1,000,000 person-years)Total number of pregnancy exposures (including 1 exposure via father)246 (N/A)31.1Abortion (induced)0 (0.0)0.00Abortion (spontaneous)7 (2.8)0.89Abortion (not specified as induced or spontaneous)4 (1.6)0.51Anembryonic gestation1 (0.4)0.13Congenital, familial, and genetic disorders5 (2.0)0.63Ectopic pregnancy0 (0.0)0.00Exposures via breast milk8 (3.3)1.01Premature birth7 (2.8)0.89Postmature birth0 (0.0)0.00Stillbirth1 (0.4)0.13Live birth/unknown or missing outcome237 (96.3)30.00 Open table in a new tab aSome cases may be counted more than once owing to multiple events reported in one case; bPercentage calculation is based on total number of pregnancy/lactation related cases (246); cThe reporting rate is based on cumulative exposure as there are no data by gender; dData collected from IMS Health; eCumulative exposure to Gla-300 (7.9 million person-years) based on data collected up to 26 January 2021. MedDRA, Medical Dictionary for Regulatory Activities; N/A, not applicable Discussion: Rates of spontaneous abortions and congenital anomalies were low for Gla-300 and consistent with rates in the general population. Use of Gla-300 during pregnancy was not associated with specific adverse events/congenital abnormalities. These results indicate no safety issues with use of Gla-300 during pregnancy.