Status: FinalisedLast updated on: 09/05/2018
1. Study identification
EU PAS Register NumberEUPAS8202
Official titleA retrospective nationwide cohort study to investigate the treatment of type 2 diabetic patients in Finland - DAHLIA
Study title acronymDAHLIA
Study typeObservational study
Brief description of the studyThere are about 280,000 people diagnosed with diabetes receiving medical treatment in Finland, most of them (85%) with type 2 diabetes mellitus (T2DM). T2DM is initially managed by life style changes only, but patients failing to control their blood glucose levels start eventually also using oral antidiabetic drugs (OADs). When the disease proceeds, many patients will need treatment with an injectable glucose-lowering drug (glucagon-like peptide-1 receptor agonist or insulin) in addition to OADs. Many new medicines have conquered the market in the recent years, but it is not completely known in detail how the glucose-lowering agents are used in a real-life setting. It would be important to understand the treatment journey in relation to disease progression and switches between different treatment levels in practice. 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. As the study period lasts until 2013 (the latest year currently available from nationwide registers), the study setting includes also the newest drug groups on the market. A parallel study is conducted in Sweden, which makes between-country comparison possible. The enrolment of similar studies also in Norway and Denmark is under planning and therefore it would be feasible to compare the results from four Nordic countries in near future. Approximately 240 000 Finnish T2DM patients will be studied in 1998-2013 by using data from nationwide patient registers.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 signed02/09/201402/09/2014
Start date of data collection31/01/201611/12/2015
Start date of data analysis30/11/201603/03/2017
Date of interim report, if expected
Date of final study report30/09/201714/11/2017
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 2Mets√§nneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Hoti 
First name Fabian 
Address line 1EPID Research Oy 
Address line 2Mets√§nneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-40-5391919 
Alternative phone number 
Fax number (incl. country code) 
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