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May Metformin be Used in Renal Failure?

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT02710448
Collaborator
Merck Serono International SA (Industry)
82
Enrollment
1
Location
1
Arm
40
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
May Metformin be Used in Renal Failure?
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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. [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. [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. [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. [Phase 4 : Day 49]

    Secondary Outcome Measures

    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. [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. [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. [Phase3 : Day 35]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Endocrinologie, Maladies Métaboliques et Nutrition Amiens France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens
    • Merck Serono International SA

    Investigators

    • Principal Investigator: LALAU J. Daniel, Professor, CHU Amiens

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT02710448
    Other Study ID Numbers:
    • PI11-PR-LALAU-2
    • 2012-001207-20
    First Posted:
    Mar 16, 2016
    Last Update Posted:
    Apr 26, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Renal Insufficiency
    Diabetes Mellitus, Type 2
    Metformin

    Study Results

    No Results Posted as of Apr 26, 2016