A cohort study to investigate the prescribing of albiglutide among women of child-bearing age who have type 2 diabetes (201795)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Name of medicine:
  EPERZAN
• Name of medicine, other:
  Tanzeum
• Study drug International non-proprietary name (INN) or common name:
  ALBIGLUTIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10) DRUGS USED IN DIABETES

  DRUGS USED IN DIABETES
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Women aged between 11 and 49 years who have been precribed treatment for type 2 diabetes.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception

  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The primary objectives of the study are to: 1) assess the proportion and characteristics of women with type 2 diabetes of child-bearing age who are prescribed albiglutide and 2) assess the proportion and characteristics of women with type 2 diabetes who are prescribed albiglutide during pregnancy.
• Outcomes:
  Surveillance in pregnant women of major congenital malformations, pregnancy losses, stillbirths and neonatal deaths.
• Data analysis plan:
  Characteristics of women in the cohort will be described by counts and proportions of the total women in the cohort. Incidence, period prevalence and days exposed to different medications will be calculated. Women who have a pregnancy during the study period will be identified. Patient characteristics at the start date of the pregnancy and prescribing received in the three months before the pregnancy start date and each trimester of pregnancy will be tabulated as counts and percentages. Patients receiving each class of medication will be described by three month period and outcome. Comparisons will be made between the albiglutide group and those receiving other medications, if sample sizes allow. Outcomes of pregnant women will be described by counts and proportions. Foetal outcomes will be compared (where numbers permit) between the different treatment combinations received by mothers during and/or in the three months before pregnancy and those whose mothers only received metformin.