NN9535-4447 Epidemiological assessment of the risk for pancreatic cancer associated with the use of semaglutide in patients with type 2 diabetes- A cohort study based on Nordic registry data

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SEMAGLUTIDE
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  600000

Study design details

• Main study objective:
  To estimate the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes.
• Outcomes:
  The endpoint used to address the primary objective is the occurrence of first time (i.e. incident) malignant neoplasm of pancreas as defined by relevant diagnostic codes.
• Data analysis plan:
  The propensity for initiating treatment with semaglutide as opposed to active comparators is estimated using logistic regression to determine the association between covariates and semaglutide initiation. The propensity score is used to match new users of semaglutide to new users of active comparators. Ozempic® and Rybelsus® initiation will be handled in two separate propensity score models. Further, patients who are treated/not treated with semaglutide as opposed to active comparators against prediction are removed by asymmetric trimming of the tails of the propensity score. In the final study sample, the hazard ratios with 95% confidence intervals for pancreatic cancer comparing users of semaglutide to users of active comparators is estimated by using a Cox proportional hazards model. Several supplementary analyses are planned as well as sensitivity analyses to check the influence from the analytical/design choices on the study findings.

Documents

Study report

First Progress Report NN9535-4447

Progress report NN9535-4447_3

_ Regulatory Progress Report NN9535-4447 progress report_2

Study, other information

_ Regulatory Progress Report NN9535-4447 progress report_2.pdf

Progress report NN9535-4447_3.pdf