Comparative effectiveness of insulin vs analogues to prevent complications of diabetes (CER insulin vs analogues)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

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

  INSULINS AND ANALOGUES
• Medical condition to be studied:
  Diabetic hyperosmolar coma

  Diabetic eye disease

  Diabetic neuropathy

  Diabetic nephropathy

  Diabetic vascular disorder

  Diabetic ketoacidosis

  Diabetic retinopathy

  Diabetic complication

Population studied

• Short description of the study population:
  Patients present in the ARS databases and resident in Toscana in incident insulin treatment (ATC code: A10A*, at least 4 prescriptions in one year), in the period between January 2005 and December 2011.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  6339

Study design details

• Main study objective:
  To assess the effectectiveness of Analogue Insulin vs Human Insulin in reducing the risk of long-term microvascular, macrovascular and metabolic complications of diabetes.
• Outcomes:
  Overall vascular and metabolic complications of diabetes mellitus. 1) Microvascular complications2) Macrovascular complications3) Metabolic complications
• Data analysis plan:
  This was a nested case-control in which cases were subjects with an incident inpatient diagnosis of vascular/metabolic diabetic complications. For each case, up to 3 sex, age and index date matched controls were randomly selected from the cohort.Incidence rate of diabetic complications was calculated by dividing the number of events by the sum of the person-time of the at risk population.Using a time-dependent exposure definition, Odds Ratio and 95% confidence interval of diabetic complications associated with current use of insulin analogue vs human insulin(≤1 year prior to the outcome) were estimated by conditional logistic regression and adjusted for selected comorbidities. As for the economic analysis, patients were allocated to specific insulin treatment considering the exposure observed during the 1st year of enrollment while costs where evaluated considering the 2nd year. A multiple linear regression analysis model was applied and adjusted for selected confounder.