CompletedPhase 2

May Metformin be Used in Renal Failure?

France82 participantsStarted 2012-06

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

Trial details

NCT IDNCT02710448

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Renal Disorder Associated With Type II Diabetes Mellitus trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

Timeframe: Phase 4 : Day 49