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Completed

NCT Number: NCT02710448

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.

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Key information

Conditions

Renal Disorder Associated With Type II Diabetes Mellitus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service d'Endocrinologie, Maladies Métaboliques et Nutrition

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

  2. 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: phase2 : Day 21

  3. 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: Phase3 : Day 35

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Merck Serono International SA

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 16, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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