Metformin use in renal impairment

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METFORMIN
• Medical condition to be studied:
  Renal impairment

  Lactic acidosis

Population studied

• Short description of the study population:
  The source population for the study will be male and female residents of Denmark and United Kingdom (UK) – the two EU member states covered by relevant medical databases. The study population will consist of patients with medically treated type 2 diabetes, defined as persons with at least one prescription for an antidiabetic medication aged 30 years or older at time of first recorded prescription. The study population was restricted to patients aged 30 years or older to exclude people with polycystic ovary syndrome and type 1 diabetes, which both are frequently diagnosed under age 30. Only patients with at least one year of prescription history before the index date (study entry or start of follow-up) will be included in order to have an observable washout period for identification of new users. In addition, we will require patients to have at least one measurement of creatinine before study inclusion in order to assess baseline renal function. In Denmark, the study population will be restricted to residents of the North and the Central Denmark regions covered by the Aarhus University Research Database, which includes information on filled prescriptions and laboratory data. In the United Kingdom, the study population will be restricted to patients treated by general practitioners participating in the Clinical Practice Research Datalink (CPRD) and who meet the study criteria.
• Age groups:
  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

  Renal impaired
• Special population of interest, other:
  Type 2 diabetes mellitus patients
• Estimated number of subjects:
  22000

Study design details

• Main study objective:
  1. To conduct a systematic review of literature relevant to metformin use and renal impairment2. To examine a.prevalence of renal impairment and other characteristics among new and prevalent users of metformin, b) use of metformin in patients with type 2 diabetes according to stage of renal function impairment c) Safety of metformin regarding renal impairment and lactic acidosis
• Outcomes:
  lactic acidosisrenal impairment
• Data analysis plan:
  -- Drug utilisation study - cross tabulation of distributions and patient characteristics-- incidence and prevalence of primary outcomes-- analysis of risk factors for lactic acidosis

Documents

Study results

Metformin use in renal impairment FINAL REPORT 30june2014_executive summary uploaded to ENCePP

Study, other information

Metformin use in renal impairment Final Protocol 2013-10-31 Data sharing statement

Study publications

Li L, Jick S, Gopalakrishnan C, Heide‐Jørgensen U, Nørrelund H, Sørensen HT, Ch…

Christiansen CF, Ehrenstein V, Heide-Jørgensen U, Skovbo S, Nørrelund H, Sørens…