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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• If ‘Not applicable’, further details on the study type:
  Nation-wide retrospective register-based linkage study
• Data collection methods:
  Secondary data collection

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10A) INSULINS AND ANALOGUES

  (A10BB) Sulfonylureas
• Medical condition to be studied:
  Diabetic coma

Population studied

• Short description of the study population:
  Patients with diabetis mellitus suffering with hypoglycaemic coma between the different insulins.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  138000

Study design details

• Main study objective:
  1) to estimate the incidence of severe hypoglycaemic coma, 2) to evaluate the recurrence of severe hypoglycaemic coma, and 3) to evaluate the number of severe hypoglycaemic coma events and duration of hospitalizations and secondary health care visits due to severe hypoglycaemic coma among diabetes patients using detemir, glargine, and NPH insulins, separately in the naïve and non-naïve populations
• Outcomes:
  Severe hypoglycaemic coma (defined as: had led to hospitalization or outpatient hospital visit due to hypoglycaemic coma) among diabetes patients using detemir, glargine and NPH insulins. Switching between different insulin among diabetic patients using detemir, glargine or NPH insulins.
• Data analysis plan:
  Crude incidence rates for detemir, glargine, and NPH-insulins, will be estimated for the first severe hypoglycaemia coma event and the recurrence of severe hypoglycaemia coma events, stratified according to the following variables: type of diabetes (T1, T2, undefined), age at start of follow-up, gender, calendar year of diagnose, time since start of insulin treatment, ever use of oral diabetes medication (A10BB) present use of other diabetes medication (A10A) and hospital district start of follow-up. The adjusted hazard ratio (HR) estimates for first occurrence and recurrence of severe hypoglycemia will be estimated using the conventional Cox’s proportional hazards model. In addition, the causal effect of the treatments will be estimated by the use of the marginal structural models (MSM).The follow-up time in the analyses starts at the first purchase of detemir, glargine or NPH-insulin during 2000-2009 and ends at time of death or end of study period, whichever occurs first.

Documents

Study results

Mäkimattila poster presentation ADA2012

Study publications

Haukka J, Hoti F, Erästö P, Saukkonen T, Mäkimattila S, Korhonen P. Evaluation …