May Metformin be Used in Renal Failure?

Centre Hospitalier Universitaire, Amiens

Status and phase

Completed

Phase 2

Conditions

Renal Disorder Associated With Type II Diabetes Mellitus

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02710448

PI11-PR-LALAU-2

2012-001207-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.