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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39977
• EU PAS number:
  EUPAS8202
• Study ID:
  39977
• Official title and acronym:
  A retrospective nationwide cohort study to investigate the treatment of type 2 diabetic patients in Finland - DAHLIA
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  There 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.
• Study status:
  Finalised

Research institution and networks

Institutions

EPID Research Oy

Study timelines

Date when funding contract was signed

Planned: 02/09/2014

Actual: 02/09/2014

Study start date

Planned: 31/01/2016

Actual: 11/12/2015

Data analysis start date

Planned: 30/11/2016

Actual: 03/03/2017

Date of final study report

Planned: 30/09/2017

Actual: 14/11/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca Nordic Baltic

Study protocol

Initial protocol

ER-9489_AZ DAHLIA_Pharmacoepidemiological study protocol_v10_20150224_final_signed

Updated protocol

ER-9489_AZ DAHLIA_Amendment to pharmacoepidemiological study protocol_v21_20170503_signed

Regulatory

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