Risk of lactic acidosis with metformin use in type 2 diabetes mellitus with renal impairment: retrospective cohort study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18820
• EU PAS number:
  EUPAS8658
• Study ID:
  18820
• Official title and acronym:
  Risk of lactic acidosis with metformin use in type 2 diabetes mellitus with renal impairment: retrospective cohort study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will be conducted using the Clinical Practice Research Datalink (CPRD). The CPRD is the English NHS observational data and interventional research service and will be the primary data source for patients in the United Kingdom.This is a retrospective cohort study in observational data. Eligible patients are those diagnosed with Type 2 Diabetes Mellitus (T2DM) with or without therapy. Patients will be included if: 1) had at least one measure of Glomerular Filtration Rate (GFR) between 2007-2012 or their chronic kidney disease (CKD) measured, 2) regardless of T2DM diagnoses date, 3) with or without therapy, 4) regardless of whether they were using insulin concomitant to other OAD drugs, and 5) have at least 1 follow-up during the study period. Patients will be excluded if: 1) they are exclusively type I diabetes insulin.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Actual: 30/06/2013

Study start date

Actual: 15/07/2013

Date of final study report

Actual: 17/10/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

Regulatory

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