Renal Insufficiency, ChronicPhase 2METXR/CKDNCT02895750
Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
A Phase 2 study testing Metformin in people with Renal Insufficiency, Chronic, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- 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
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2017to 10 Oct 2022
- 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
- Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)
Who cannot join
- Pregnancy and lactation
- Hyperlactatemia (> 2.5 mmol/L)
- No creatinine levels available since 3 months
- Severe hepatic insufficiency
- No liver function parameters available
- Need of investigation with iodized contrast media
- Hypersensitivity to metformin
Trial locations and contacts
1 site in 1 country.
About this study
There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Metformin
- Keywords
- diabetes type 2, Metformin, chronic kidney disease, CKD
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)
| Study group | Role | What they receive |
|---|---|---|
| normal to mild renal impairment | Experimental | (12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN Receives: Drug: Metformin |
| mild to moderate renal impairment | Experimental | (12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN Receives: Drug: Metformin |
| moderate to severe renal impairment | Experimental | (12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of once daily Metformin XR on 24-h blood glucose control
The blood glucose will be measured continuously throughout the study using continuous glucose monitoring (mean, range and variability in each therapeutic block).
Measured: week 12
Secondary outcomes (2)
Tolerability of Metformin XR in mild to moderate (CKD)
Blood creatinine levels will be measured at the end of each therapeutic block. (week 0, 2, 4, 6, 8, 10 and 12)
Measured: week 0, 2, 4, 6, 8, 10 and 12
Tolerability of Metformin XR in mild to moderate (CKD) 2
blood lactate levels will be measured at the end of each therapeutic block.
Measured: week 0, 2, 4, 6, 8, 10 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start30 Aug 2017
- Primary completion8 Jan 2022
- Study completion10 Oct 2022
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 Insufficiency, ChronicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Daniel LALAU, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895750
- Sponsor's protocol ID
- PI2016_843_0008
- Acronym
- METXR/CKD
- Status last verified
- Sep 2025
- First submitted
- 26 Jul 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lalau JD, Bennis Y, Al-Salameh A, Hurtel-Lemaire AS, Fendri S. Pharmacodynamics and pharmacokinetics of extended-release metformin in patients with type 2 diabetes and chronic kidney disease stage 3B. Diabetes Obes Metab. 2022 Jan;24(1):166-170. doi: 10.1111/dom.14554. Epub 2021 Oct 4. No abstract available.
PubMed 34545662
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
- Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
- ClinicalTrials.gov ID
- NCT02895750
- Acronym / sponsor ID
- METXR/CKD / PI2016_843_0008
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- diabetes type 2, Metformin, chronic kidney disease, CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 12 Sep 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.
There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal to mild renal impairment | Experimental | Drug: Metformin(12 subjects): eGFR ≥ 60 (normal renal function to mild renal impairment, CKD stages 1-2) METFORMIN |
| mild to moderate renal impairment | Experimental | Drug: Metformin(12 subjects): eGFR 59-45 (mild to moderate renal impairment, CKD stage 3a) METFORMIN |
| moderate to severe renal impairment | Experimental | Drug: Metformin(12 subjects): eGFR 44-30 (moderate to severe renal impairment, CKD stage 3b) METFORMIN |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)
Key exclusion criteria (7 listed)
- Pregnancy and lactation
- Hyperlactatemia (> 2.5 mmol/L)
- No creatinine levels available since 3 months
- Severe hepatic insufficiency
- No liver function parameters available
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: GlucophageMetformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively) | Drug | mild to moderate renal impairment, moderate to severe renal impairment, normal to mild renal impairment |
Primary outcome
Efficacy of once daily Metformin XR on 24-h blood glucose control
Time frame: week 12
The blood glucose will be measured continuously throughout the study using continuous glucose monitoring (mean, range and variability in each therapeutic block).
2 secondary outcomes
Tolerability of Metformin XR in mild to moderate (CKD)
Time frame: week 0, 2, 4, 6, 8, 10 and 12
Tolerability of Metformin XR in mild to moderate (CKD) 2
Time frame: week 0, 2, 4, 6, 8, 10 and 12
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 34545662Lalau JD, Bennis Y, Al-Salameh A, Hurtel-Lemaire AS, Fendri S. Pharmacodynamics and pharmacokinetics of extended-release metformin in patients with type 2 diabetes and chronic kidney disease stage 3B. Diabetes Obes Metab. 2022 Jan;24(1):166-170. doi: 10.1111/dom.14554. Epub 2021 Oct 4. 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.
Jean-Daniel LALAU, MD, PhD 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 Insufficiency, Chronic, 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 1 inclusion and 7 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?
Efficacy of once daily Metformin XR on 24-h blood glucose control (time frame: week 12). 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 NCT02895750, 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.