Metformin Use in Chronic Kidney Disease: The CKD-Met Study

• Conditions: Type 2 Diabetes; Chronic Kidney Disease
• Interventions: Other: modalities of metformin prescription

• Registration Number: NCT02844153
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Primary Completion: 2018-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 18 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

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Exclusion Criteria

• On-going treatment by dialysis
• Kidney transplantation
• Type 1 diabetes
• Missing data (metformin treatment)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5)	modalities of metformin prescription	All patients with type 2 diabetes seen for the first time by a nephrologist.

Primary Outcome Measures

Name	Time	Method
Percentage of patients receiving metformin	every January 1st up to 2020	metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded.

Secondary Outcome Measures

Name	Time	Method
CKD stages	every January 1st up to 2020	CKD stages will be recorded.
Dose of metformin	every January 1st up to 2020	metformin use during chronic kidney disease. Dose of metformin will be recorded.
Doses of oral antidiabetes medications	every January 1st up to 2020	Oral antidiabetic medications use during chronic kidney disease. Doses of oral antidiabetes medications (sulfonylureas, alpha-glucosidase inhibitors, Dipeptidyl peptidase-4 (DPP4) inhibitors, incretin mimetics, SGLT2 inhibitors) will be recorded.
starting time of insulin	every January 1st up to 2020	need for insulin
Occurence of reasons for non-prescription of metformin	every January 1st up to 2020	metformin use during chronic kidney disease. Occurence of reasons for non-prescription of metformin will be recorded.
occurrence of lactic acidosis	every January 1st up to 2020	data file analysis and record of lactic acidosis episodes

Trial Locations

Locations (1)

Claude Bernard University, Lyon, France, Lyon Sud university hospital; 🇫🇷 Pierre-Bénite, France