Metformin Use in Chronic Kidney Disease: The CKD-Met Study
CKD-Met
1 other identifier
observational
1,000
1 country
1
Brief Summary
Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit. Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients. The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJuly 26, 2016
July 1, 2016
4 years
July 20, 2016
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients receiving metformin
metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded.
every January 1st up to 2020
Secondary Outcomes (6)
Dose of metformin
every January 1st up to 2020
Occurence of reasons for non-prescription of metformin
every January 1st up to 2020
CKD stages
every January 1st up to 2020
Doses of oral antidiabetes medications
every January 1st up to 2020
starting time of insulin
every January 1st up to 2020
- +1 more secondary outcomes
Study Arms (1)
6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5)
All patients with type 2 diabetes seen for the first time by a nephrologist.
Interventions
Metformin prescription or not, in each CKD stage
Eligibility Criteria
All patients with type 2 diabetes seen by a nephrologist at the University hospital of Lyon Sud, between March 2014 and March 2020
You may qualify if:
- years old or more
- Type 2 diabetes
- Seen by a nephrologist (consultation or hospitalization) between March 2014 and March 2020 in the Department of Nephrology, Lyon Sud university hospital, France
You may not qualify if:
- On-going treatment by dialysis
- Kidney transplantation
- Type 1 diabetes
- Missing data (metformin treatment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Claude Bernard University, Lyon, France, Lyon Sud university hospital
Pierre-Bénite, 69310, France
Related Publications (1)
Coliche V, Koppe L, Laville M, Nouvier M, Pelletier S, Trolliet P, Fouque D. Metformin misuse in chronic kidney disease. Diabetes Metab. 2020 Sep;46(4):337-339. doi: 10.1016/j.diabet.2018.07.005. Epub 2018 Jul 24. No abstract available.
PMID: 30145030DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denis FOUQUE, MD PhD
Claude Bernard University, Lyon, France, Lyon Sud university hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 26, 2016
Study Start
March 1, 2014
Primary Completion
March 1, 2018
Study Completion
March 1, 2020
Last Updated
July 26, 2016
Record last verified: 2016-07