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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/39983
• EU PAS number:
  EUPAS21945
• Study ID:
  39983
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  This observational study will describe patient characteristics and rate of cardiovascular (CV) and mortality outcomes in patients with type 2 diabetes mellitus (T2DM) who are initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs). The study will analyze the risk of hospitalization for heart failure (HF), other CV outcomes, severe hypoglycemia, kidney disease (KD), and all-cause mortality in T2DM patients who initiate use or treatment with SGLT-2s compared to patients initiating other glucose lowering drugs (GLD) in Finland.
• Study status:
  Planned

Research institution and networks

Institutions

EPID Research Oy

Study timelines

Date when funding contract was signed

Actual: 18/10/2017

Study start date

Planned: 31/01/2018

Date of final study report

Planned: 31/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca Nordic Baltic

Study protocol

Initial protocol

CVD REAL FINLAND Non Interventional Study Protocol v1.0 FINAL-v4_signed

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable