NCT02844153

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

4 years

First QC Date

July 20, 2016

Last Update Submit

July 25, 2016

Conditions

Keywords

Metformintype 2 diabeteschronic kidney diseaseantidiabetic medicationslactic acidosis

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.

Other: modalities of metformin prescription

Interventions

Metformin prescription or not, in each CKD stage

6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Renal Insufficiency, ChronicAcidosis, Lactic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAcidosisAcid-Base Imbalance

Study Officials

  • Denis FOUQUE, MD PhD

    Claude Bernard University, Lyon, France, Lyon Sud university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis FOUQUE, MD PhD

CONTACT

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

Locations