May Metformin be Used in Renal Failure?

NCT ID: NCT02710448

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-10-31

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.

Conditions

Renal Disorder Associated With Type II Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Metformin in patients with renal failure

Group Type: EXPERIMENTAL

Metformin

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

phase1 : 500 mg/d; phase2 : 2 x 500 mg/d; phase3 : 2 x 1000 mg/d; phase4 : 3 x 1000 mg/d

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono International SA

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LALAU J. Daniel, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

Service d'Endocrinologie, Maladies Métaboliques et Nutrition

Amiens, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 24596656 (View on PubMed)

Other Identifiers

2012-001207-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI11-PR-LALAU-2

Identifier Type: -

Identifier Source: org_study_id