Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Case-control
Cohort
Study drug and medical condition

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

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 total mortality (TM) associated with the use of NIBGLD and insulins and insulin analogs.

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