Safety Evaluation of Adverse Reactions in Diabetes - Comparative studies (SAFEGUARD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000093996

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

Population studied

• Short description of the study population:
  All patients in the databases during the study period who have at least 365 consecutive days of valid data with at least one prescription/dispensing of a NIBGLD (ATC: A10B – Annex 1) or insulin or insulin analogues (ATC: A10A – Annex 1) in the study period.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  Diabetes mellitus patients
• Estimated number of subjects:
  2200000

Study design details

• Main study objective:
  The main objective of these observational studies is to estimate the risk of myocardial infarction (MI), heart failure (HF), ventricular arrhythmia (VA)/sudden cardiac death (SCD), ischemic stroke (IS), hemorrhagic stroke (HS), acute pancreatitis (AP), pancreatic cancer (PC), bladder cancer (BC) and
• Outcomes:
  The primary objective of these observational studies is to estimate the risk of myocardial infarction (MI), heart failure (HF), ventricular arrhythmia (VA)/sudden cardiac death (SCD), ischemic stroke (IS), hemorrhagic stroke (HS), acute pancreatitis (AP), pancreatic cancer (PC), bladder cancer (BC) and total mortality (TM) associated with the use of NIBGLD and insulins and insulin analogs. To assess the background rates of the different events of interest in the population of subjects with T2DM
• Data analysis plan:
  The incidence rate (IR) and direct standardized incidence rates (SIRs) with the 95% confidence intercal (95%CI) of each outcome of interest in each database will be estimated at the population level for harmonization purposes. To assess the risk of the outcomes of interest (MI, HF, VA/SCD, HS, IS, AP, PC and BC), associated with the use of NIBGLD and insulins and insulin analogues, Conditional logistic regression will be used to calculate the unadjusted and adjusted odds ratios (ORs) with their 95% confidence intervals (CIs) with reference to another active compound which will be selected based on drug utilization studies. For the cohort studies, hazard ratios and incidence rates (IR) as well as the relative risk for TM with their 95% CIs will be estimated using Cox-regression analysis. All analyses will at first be performed for each database(DB) separately and the heterogeneity among DBs will be examined through heterogeneity indexes. Different sensitivity analyses will be performed

Documents

Results tables

Safety Evaluation of Adverse Reactions in Diabetes_report