May Metformin be Used in Renal Failure?

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 Overview

• Status: Completed
• Conditions: Renal Disorder Associated With Type II Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Service d'Endocrinologie, Maladies Métaboliques et Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Metformin; Metformin in patients with renal failure

Drug: Metformin; 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); Other Names: phase1 : 500 mg/d; phase2 : 2 x 500 mg/d; phase3 : 2 x 1000 mg/d; phase4 : 3 x 1000 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	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.	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.	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.	Phase 4 : Day 49

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	phase1 : Day 7
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.	phase2 : Day 21
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.	Phase3 : Day 35

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Merck Serono International SA
• Investigators: Principal Investigator: LALAU J. Daniel, Professor, CHU Amiens

Publications and helpful links

General Publications

• Briet C, Saraval-Gross M, Kajbaf F, Fournier A, Hary L, Lalau JD. Erythrocyte metformin levels in patients with type 2 diabetes and varying severity of chronic kidney disease. Clin Kidney J. 2012 Feb;5(1):65-67. doi: 10.1093/ndtplus/sfr134. No abstract available.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimated): March 16, 2016

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency; Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: PI11-PR-LALAU-2; 2012-001207-20 (EudraCT Number)