Patient characteristics and cardiovascular and mortality outcomes in patients with type 2 diabetes mellitus initiating treatment with sodium-glucose co-transporter-2 inhibitors and other antidiabetic medications in Finland

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DAPAGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• 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:
  400000

Study design details

• Main study objective:
  The primary objective of this study is to compare the risk for hospitalization for heart failure, in patients with T2DM who are new users of SGLT-2s as a class or dapagliflozin separately, versus an active comparison group including patients with T2DM who are new users of other GLD.
• Outcomes:
  Hospitalization for heart failure, Other CV outcomes, severe hypoglycemia, KD, all-cause mortality and health care resource utilization
• Data analysis plan:
  The event rates and baseline characteristics for each treatment group will be summarized descriptively. Propensity scores (PS) will be calculated to assess comparability between SGLT-2 users, dapagliflozin users, and the groups of matched comparators (DPP-4 and other GLD users). The primary objective is to provide a formal statistical comparison between the treatment and comparator group with respect to hospitalizations for HF using a hazard ratio (HR) (or other appropriate measure).