An observational study of patient cohorts who previously received long-term treatment with pioglitazone or placebo in addition to existing antidiabetic medications

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PIOGLITAZONE
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  High risk type II diabetes mellitus (T2DM) patients previously enrolled in PROactive study, treated with pioglitazone or placebo in addition to their existing anti diabetic medication. Patients with completion of the final visit of the PROactive Study and willingness and ability to give written informed consent for the observational study were included.
• Age groups:
  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  3599

Study design details

• Main study objective:
  The study aimed to investigate whether prior long term treatment of pioglitazone had any effect on the composite endpoint (including all-cause mortality, non-fatal myocardial infarction, coronary intervention, stroke, major leg amputation, bypass surgery or revascularisation in the leg, and the incidence, nature and pattern of newly diagnosed malignancies) in the PROactive enrolled T2DM patients.
• Outcomes:
  Primary outcome included the time from randomization to occurrence of first macro-vascular event or death (which includes all-cause mortality, non-fatal myocardial infarction, coronary intervention, stroke, major leg amputation, bypass surgery or revascularisation in the leg) in T2DM patients.
• Data analysis plan:
  Kaplan-Meier method was used for calculating survival curves for pioglitazone and placebo. Estimates of the hazard ratio (HR) were calculated using Cox model regression methods.

Documents

Study results

AD-4833-EC445-RDS-2015-07-15