Status: FinalisedLast updated on: 18/08/2016
1. Study identification
EU PAS Register NumberEUPAS2278
Official titleAssessment of association between severe hypoglycaemia and use of detemir, glargine and NPH insulins (ER11-9417/ U1111-1120-7164)
Study title acronym
Study typeOther: nation-wide register-based study
Brief description of the studyHypoglycaemia events occur among diabetes patients who use insulin for treatment of diabetes mellitus. From the oral treatments supholnylurea (SU) products can also cause hypoglycaemia. Risk of hypoglycaemia is increased with age and duration of diabetes. Severe hypoglycemia can result in permanent neurological sequelae including neuronal cell death. Hypoglycemia also increases platelet aggregation and fibrinogen formation, which may accelerate vascular compromise in the brain. Among older patients with type 2 diabetes, a history of severe hypoglycaemic episodes severe enough to require hospitalization or an emergency department visit are associated with increased risk of dementia, particularly for patients who have a history of multiple episodes. The development of long-acting basal insulin analogues with improved pharmacokinetics, which are able to more closely replicate endogenous insulin secretion, has been shown to have a positive effect on the balance between effective glycaemic control and hypoglycaemic risk compared to NPH insulin. The primary aim of this retrospective follow-up study is to evaluate the differences in the incidence of the hospitalization and the secondary health care visits due to diabetes mellitus with hypoglycaemic coma between the different insulins.
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 Haukka
First name Jari
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 signed26/01/2011
Start date of data collection09/03/2011
Start date of data analysis
Date of interim report, if expected
Date of final study report14/03/201218/06/2012
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovo Nordisk Farma Oy100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Haukka
First name Jari
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358-45-6346672 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Haukka 
First name Jari 
Address line 1EPID Research Oy 
Address line 2Metsänneidonkuja 12 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358-45-6346672 
Alternative phone number 
Fax number (incl. country code) 
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