A retrospective nationwide cohort study to investigate the treatment of type 2 diabetic patients in Finland - DAHLIA

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10) DRUGS USED IN DIABETES
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Study population consists of T2DM patients in Finland identified by the following inclusion and exclusion criteria:; ; Inclusion criteria:; • A filled prescription for use of any blood glucose lowering (ATC: A10) drug between 1998 and 2013 or a special reimbursement for diabetes (refund code 103) by end of 2013.; ; Exclusion criteria:; • Patients who are entitled to special reimbursement for diabetes (refund code 103) with ICD010 diagnosis E10, E12, E13, E14 or E89.1 indicative of type 1 diabetes, diabetes related to malnutrition, other specified diabetes, unspecific diabetes or postprocedural hypoinsulinaemia, respectively, without refund 103 for E11 (i.e. other precondition for 103 than T2DM: ICD010 E11).; • Patients with hospital visits based on ICD010 E10, O24.0, E12, O24.2, E13, O24.3, O24.4, O24.9, E89.1 or P70.2 (referring to other diabetes mellitus than T2DM also during pregnancy or at birth) without E11 or O24.1
• Age groups:
  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:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  350000

Study design details

• Main study objective:
  The purpose of the study is to describe type 2 diabetes mellitus patients in Finland, especially their antidiabetic medication use (e.g. persistence, concomitance and switching), and to discuss the progression of the disease in terms of comorbidities and drug treatment. As a secondary objective the study includes health economic characteristics.
• Data analysis plan:
  R language will be used for in data management for creating the analysis database and in statistical analysis for creating tabulations and graphics as well as in all statistical modelling. The annual prevalent and incident population will be described on yearly basis from 1998 to end of follow-up (year 2014). The summaries will include patient demographics, comorbidities, use of blood glucose-lowering drugs and use of other drugs. Incident population will be described on index date and prevalent population on the 1st of July. Both counts and percentages will be given.If a variable is totally missing it is excluded from the analysis. If a variable is missing for only some of the patients a missing data category is added and used in the analysis. The principles of the statistical analysis by objectives are outlined in protocol. More detailed statistical analysis plans will be written separately.

Documents

Study results

ER-9489-DAHLIA_Report synopsis_V1.0_20171114_signed

Study, other information

ER-9489_Annex5_DoIForm_Johan Eriksson_signed

ER-9489_AZ DAHLIA_Pharmacoepidemiological study protocol_v20_20150827_signed

ER-9489_AZ DAHLIA_Pharmacoepidemiological study protocol_v21_20160607_signed