May Metformin be Used in Renal Failure?

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborator: Merck Serono International SA
• Treatments: Metformin

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.