Assessment of association between severe hypoglycaemia and use of detemir, glargine and NPH insulins (ER11-9417/ U1111-1120-7164)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14838
• EU PAS number:
  EUPAS2278
• Study ID:
  14838
• Official title and acronym:
  Assessment of association between severe hypoglycaemia and use of detemir, glargine and NPH insulins (ER11-9417/ U1111-1120-7164)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  Hypoglycaemia 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.
• Study status:
  Finalised

Research institution and networks

Institutions

EPID Research Oy

Study timelines

Date when funding contract was signed

Actual: 26/01/2011

Study start date

Actual: 09/03/2011

Date of final study report

Planned: 14/03/2012

Actual: 18/06/2012

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk Farma Oy

Regulatory

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