May Metformin be Used in Renal Failure?

Phase 2

Completed

• Conditions: Renal Disorder Associated With Type II Diabetes Mellitus
• Interventions: Drug: Metformin

• Registration Number: NCT02710448
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-10
• Primary Completion: 2015-06
• Study Completion: 2015-10
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-16
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Metformin in patients with renal failure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Service d'Endocrinologie, Maladies Métaboliques et Nutrition; 🇫🇷 Amiens, France