Renal Disorder Associated With Type II Diabetes MellitusPhase 2NCT02710448
May Metformin be Used in Renal Failure?
A Phase 2 study testing Metformin in people with Renal Disorder Associated With Type II Diabetes Mellitus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The study is to treat metformin dose-escalation diabetic subjects of all stages of renal failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a possible accumulation than those of plasma) to the therapeutic range. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Disorder Associated With Type II Diabetes Mellitus
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Oct 2015
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients not treated with metformin, no treatment diabetic or have been treated but poorly balanced (HbA1c> 7%) and an applicant building with metformin; at any stage renal stable (stages 1-5 according to the classification MDRD)
- Patients aged 18 to 80 years;
- Patients with an assessment of renal function dating back more than 3 months;
- Patients whose renal function is stable, on the criterion of the absence of fluctuation over 30% of renal function of creatinine clearance in the last three months, a reference to renal function at least 3 months from the balance sheet inclusion is necessary.
Who cannot join
- Patient over 80 years
- Patients incapacitated adults (protected under guardianship)
- No previous reference creatinine;
- Fluctuation over 30% of renal function (creatinine clearance) in the three months;
- Reduction in BMI of more than 5% during the last 3 months;
- Severe hepatic impairment (Child stage> A);
- No reference to liver stages 3-5
- Patients to be an X-ray with injection of contrast.
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Endocrinologie, Maladies Métaboliques et Nutrition
Amiens, 80054
About this study
The study is to treat metformin dose-escalation diabetic subjects of all stages of renal failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients by stage is considered, 60 patients in total.
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called phase1 : 500 mg/d, phase2 : 2 x 500 mg/d, phase3 : 2 x 1000 mg/d, phase4 : 3 x 1000 mg/d
Metformin (Glucophage ®), oral antidiabetic, will be administered as it is usually recommended: engaged during or at the end of the meal in the evening for the single dose 500 mg (Phase 1), the evening and morning for total doses of 1000 mg, 2000 mg and 3000 mg (with, respectively, 2 tab. 500 mg, 2 tab. to 1000 mg, 1 tab. to 1000 mg and 2 tab. to 1000 mg), a fourth dose is also scheduled to stage one (3000 mg / d)
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin in patients with renal failure Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Measured: Phase 1 : Day 7
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Measured: Phase 2 : Day 21
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Measured: Phase 3 : Day 35
the percentage of patients in stage 1 of chronic kidney disease (CKD) each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Measured: Phase 4 : Day 49
Secondary outcomes (3)
the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.
Measured: phase1 : Day 7
the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.
Measured: phase2 : Day 21
the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.
Measured: Phase3 : Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionOct 2015
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 Renal Disorder Associated With Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Responsible party
- Sponsor
- Investigators
- LALAU J. Daniel, Professor, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710448
- Sponsor's protocol ID
- PI11-PR-LALAU-2
- Other IDs
- 2012-001207-20
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2012
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Briet C, Saraval-Gross M, Kajbaf F, Fournier A, Hary L, Lalau JD. Erythrocyte metformin levels in patients with type 2 diabetes and varying severity of chronic kidney disease. Clin Kidney J. 2012 Feb;5(1):65-67. doi: 10.1093/ndtplus/sfr134. No abstract available.
PubMed 24596656
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- May Metformin be Used in Renal Failure?
- ClinicalTrials.gov ID
- NCT02710448
- Acronym / sponsor ID
- PI11-PR-LALAU-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Mar 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.
The study is to treat metformin dose-escalation diabetic subjects of all stages of renal failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients by stage is considered, 60 patients in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin in patients with renal failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetic patients not treated with metformin, no treatment diabetic or have been treated but poorly balanced (HbA1c> 7%) and an applicant building with metformin; at any stage renal stable (stages 1-5 according to the classification MDRD)
- Patients aged 18 to 80 years;
- Patients with an assessment of renal function dating back more than 3 months;
- Patients whose renal function is stable, on the criterion of the absence of fluctuation over 30% of renal function of creatinine clearance in the last three months, a reference to renal function at least 3 months from the balance sheet inclusion is necessary.
Key exclusion criteria (8 listed)
- Patient over 80 years
- Patients incapacitated adults (protected under guardianship)
- No previous reference creatinine;
- Fluctuation over 30% of renal function (creatinine clearance) in the three months;
- Reduction in BMI of more than 5% during the last 3 months;
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 |
|---|---|---|
| MetforminAlso: phase1 : 500 mg/d, phase2 : 2 x 500 mg/d, phase3 : 2 x 1000 mg/d, phase4 : 3 x 1000 mg/dMetformin (Glucophage ®), oral antidiabetic, will be administered as it is usually recommended: engaged during or at the end of the meal in the evening for the single dose 500 mg (Phase 1), the evening and morning for total doses of 1000 mg, 2000 mg and 3000 mg (with, respectively, 2 tab. 500 mg, 2 tab. to 1000 mg, 1 tab. to 1000 mg and 2 tab. to 1000 mg), a fourth dose is also scheduled to stage one (3000 mg / d) | Drug | Metformin |
Primary outcome
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Time frame: Phase 1 : Day 7
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Time frame: Phase 2 : Day 21
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Time frame: Phase 3 : Day 35
the percentage of patients in stage 1 of chronic kidney disease (CKD) each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment.
Time frame: Phase 4 : Day 49
3 secondary outcomes
the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.
Time frame: phase1 : Day 7
the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.
Time frame: phase2 : Day 21
the percentage of patients in stages 3-5 of CKD each stage renal disease with a blood erythrocyte remaining within the therapeutic range or higher, and but without significative hyperlactatemia (≥ 2.5 mmol / l) in the latter case.
Time frame: Phase3 : Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 24596656Briet C, Saraval-Gross M, Kajbaf F, Fournier A, Hary L, Lalau JD. Erythrocyte metformin levels in patients with type 2 diabetes and varying severity of chronic kidney disease. Clin Kidney J. 2012 Feb;5(1):65-67. doi: 10.1093/ndtplus/sfr134. 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.
LALAU J. Daniel, Professor principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Renal Disorder Associated With Type II Diabetes Mellitus, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 19 Sep 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients in each category of renal function whose rate of erythrocyte metformin remain within the therapeutic range, at each stage of treatment. (time frame: Phase 1 : Day 7). The study lists 4 primary outcomes in all. 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 NCT02710448, 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 19 Sep 2025.