Type 2 DiabetesCKD-MetNCT02844153
Metformin Use in Chronic Kidney Disease: The CKD-Met Study
An observational study of Type 2 Diabetes and Chronic Kidney Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease
- What is being tested?
- modalities of metformin prescription
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- On-going treatment by dialysis
- Kidney transplantation
- Type 1 diabetes
- Missing data (metformin treatment)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Claude Bernard University, Lyon, France, Lyon Sud university hospital
Pierre-Bénite, 69310
Denis FOUQUE, Pr, MD PhD, (0)4 7267 8704 ext. +33, denis.fouque@univ-lyon1.fr
About this study
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.
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Being tested
- modalities of metformin prescription
- Keywords
- Metformin, type 2 diabetes, chronic kidney disease, antidiabetic medications, lactic acidosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modalities of metformin prescriptionOther
Metformin prescription or not, in each CKD stage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: modalities of metformin prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving metformin
metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded.
Measured: every January 1st up to 2020
Secondary outcomes (6)
Dose of metformin
metformin use during chronic kidney disease. Dose of metformin will be recorded.
Measured: every January 1st up to 2020
Occurence of reasons for non-prescription of metformin
metformin use during chronic kidney disease. Occurence of reasons for non-prescription of metformin will be recorded.
Measured: every January 1st up to 2020
CKD stages
CKD stages will be recorded.
Measured: every January 1st up to 2020
Doses of oral antidiabetes medications
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.
Measured: every January 1st up to 2020
starting time of insulin
need for insulin
Measured: every January 1st up to 2020
occurrence of lactic acidosis
data file analysis and record of lactic acidosis episodes
Measured: every January 1st up to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis FOUQUE, MD PhD, Principal investigator, Claude Bernard University, Lyon, France, Lyon Sud university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844153
- Sponsor's protocol ID
- 69HCL16_0408
- Acronym
- CKD-Met
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30145030
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Use in Chronic Kidney Disease: The CKD-Met Study
- ClinicalTrials.gov ID
- NCT02844153
- Acronym / sponsor ID
- CKD-Met / 69HCL16_0408
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Keywords
- Metformin, type 2 diabetes, chronic kidney disease, antidiabetic medications, lactic acidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5) | – | Other: modalities of metformin prescriptionAll patients with type 2 diabetes seen for the first time by a nephrologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- On-going treatment by dialysis
- Kidney transplantation
- Type 1 diabetes
- Missing data (metformin treatment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modalities of metformin prescriptionMetformin prescription or not, in each CKD stage | Other | 6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5) |
Primary outcome
Percentage of patients receiving metformin
Time frame: every January 1st up to 2020
metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded.
6 secondary outcomes
Dose of metformin
Time frame: every January 1st up to 2020
Occurence of reasons for non-prescription of metformin
Time frame: every January 1st up to 2020
CKD stages
Time frame: every January 1st up to 2020
Doses of oral antidiabetes medications
Time frame: every January 1st up to 2020
starting time of insulin
Time frame: every January 1st up to 2020
occurrence of lactic acidosis
Time frame: every January 1st up to 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Derived from this study: PubMed 30145030Coliche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis FOUQUE, MD PhD principal investigator
Claude Bernard University, Lyon, France, Lyon Sud university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Chronic Kidney Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis FOUQUE, MD PhD ((0)4 7267 8704 ext. +33, denis.fouque@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients receiving metformin (time frame: every January 1st up to 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02844153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.