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May Metformin be Used in Renal Failure?

Primary Purpose

Renal Disorder Associated With Type II Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Metformin
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Disorder Associated With Type II Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Service d'Endocrinologie, Maladies Métaboliques et Nutrition

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin

Arm Description

Metformin in patients with renal failure

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 10, 2012
Last Updated
April 25, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Merck Serono International SA
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1. Study Identification

Unique Protocol Identification Number
NCT02710448
Brief Title
May Metformin be Used in Renal Failure?
Official Title
May Metformin be Used in Renal Failure?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Merck Serono International SA

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disorder Associated With Type II Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin in patients with renal failure
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
phase1 : 500 mg/d, phase2 : 2 x 500 mg/d, phase3 : 2 x 1000 mg/d, phase4 : 3 x 1000 mg/d
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LALAU J. Daniel, Professor
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Endocrinologie, Maladies Métaboliques et Nutrition
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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