Clinical trial NCT02710448: May Metformin be Used in Renal Failure?
Official title: May Metformin be Used in Renal Failure?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Disorder Associated With Type II Diabetes Mellitus
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2016-03-16
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. A number of 12 patients by stage is considered, 60 patients in total.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: Phase 1 : Day 7
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.
timeFrame: Phase 2 : Day 21
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.
timeFrame: Phase 3 : Day 35
measure: 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.
timeFrame: Phase 4 : Day 49
Secondary outcomes:
measure: 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.
timeFrame: phase1 : Day 7
measure: 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.
timeFrame: phase2 : Day 21
measure: 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.
timeFrame: Phase3 : Day 35
Other outcomes:
Locations:
city: Amiens
country: France
facility: Service d'Endocrinologie, Maladies Métaboliques et Nutrition
Study officials:
affiliation: CHU Amiens
name: LALAU J. Daniel, Professor
role: PRINCIPAL_INVESTIGATOR
References: