PRJ2376: A cohort study to investigate the prescribing of albiglutide among women of child bearing age

Trial description: Recent reviews of diabetes medication in pregnancy reported that there is very limited data available on safety of medications for treating type 2 diabetes during pregnancy. There are limited amount of data from the use of albiglutide in pregnant women. This is a cohort study to be conducted using the Clinical Practice Research Datalink (CPRD) to investigate prescribing for type 2 diabetes in women of child-bearing age in the UK. The primary objectives are to assess the proportion and characteristics of women with type 2 diabetes of child-bearing age who are prescribed albiglutide and to assess the proportion and characteristics of women with type 2 diabetes who are prescribed albiglutide during pregnancy. Outcomes of women prescribed albiglutide during pregnancy including reported major congenital malformations, pregnancy losses, stillbirths and neonatal deaths will be described. Characteristics of the study population and the sub-group of patients with pregnancies occurring during the study period will be reported as counts and proportions. Existing prescribing will be described at cohort entry and new prescribing during the study period will be described by year in terms of incidence, prevalence and exposure rate by medication or group of medications. Comparisons of characteristics between those who receive prescriptions for albiglutide and those who receive prescriptions for other types of anti-diabetic medications will be made. Pregnancy outcomes will be collated and described in terms of patient characteristics and medication prescribed, if numbers are sufficient for this.