NN304-4528: Retrospective Cohort study of all-Cause and Cardiovascular Mortality in type 2 diabetes patients using basal insulin Detemir and Glargine

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post Authorisation Safety Study

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  The study population comprised insulin-naïve patients with T2D, aged 40 years or above initiating therapy with basal insulins detemir or insulin glargine between 24 June 2004 and 10 May 2019.; T2D patients were defined as a record of a read code for T2D, without any record of a read code for type 1 diabetes (T1D) ever in the database. New users of insulin detemir or insulin glargine was defined as a record of a prescription of one of these treatments at or after 24 June 2004, as this was the date where both drugs occurred in the database, and thus were available for prescription in the UK. Only insulin-naïve patients without history of prescription of any type of insulin were included. Moreover, only patients with acceptable research quality data from one year prior to initiation of insulin detemir or insulin glargine were included in the study (i.e. only patients flagged as acceptable patients in the database were included and moreover the latest of the CPRD variables up to standard date (uts) and current registration date (crd) should be at least one year prior to initiation).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The overall objective is to estimate the differences in all-cause and cardiovascular mortality rates between new users of basal insulin Glargine and Detemir in a population-based study of type 2diabetes patients 40 years or older in UK in the years 2004-2018.
• Outcomes:
  1. Age at all cause death or censoring2. Age at death of cardiovascular disease
• Data analysis plan:
  Kaplan-Meier curves for survival will be estimated for the cohort, and Cox's proportional hazards (PH) models will be used to calculate adjusted hazard ratios (HRs) with 95% confidence intervals(CI) for mortality associated with insulin use. Age will be used as the underlying time-scale in the model. P-values of less than 0.05 will be considered statistically significant. The Cox’s PH model will be adjusted for selected potential confounders as well as for the time dependent variables as described in section “P”. The PH assumption for basal insulin and gender will be examined by plotting the stratified Kaplan-Meier curves and by residual plots. Continuous variables will betested for linearity by including a squared term in the model.

Documents

Study results

4528-nsr-report-encepp-redacted