May Metformin be Used in Renal Failure?

Centre Hospitalier Universitaire, Amiens82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Disorder Associated With Type II Diabetes Mellitus

Interventions

MetforminDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Service d'Endocrinologie, Maladies Métaboliques et Nutrition

Amiens, France

Outcomes

Primary Outcomes

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

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

Time frame: phase2 : Day 21

Time frame: Phase3 : Day 35

Data from ClinicalTrials.gov

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