Status: Planned First registered on: 08/12/2017
Last updated on: 17/01/2020
1. Study identification
EU PAS Register NumberEUPAS21945
Official titlePatient 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 title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Hoti
First name Fabian
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/10/2017
Start date of data collection31/01/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca Nordic Baltic100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Hoti
First name Fabian
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
Email address fabian.hoti@epidresearch.com
Public Enquiries
Title Dr 
Last name Hoti 
First name Fabian 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
Email address fabian.hoti@epidresearch.com 
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