May Metformin be Used in Renal Failure?

NCT02710448 | Completed Phase 2

• 2 other identifiers: PI11-PR-LALAU-22012-001207-20
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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 Outcomes (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.

  phase1 : Day 7

• 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

• 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

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin in patients with renal failure

Drug: Metformin

Interventions

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)

Also known as: phase1 : 500 mg/d, phase2 : 2 x 500 mg/d, phase3 : 2 x 1000 mg/d, phase4 : 3 x 1000 mg/d

Metformin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Merck Serono International SA: collaborator

Study Sites (1)

Service d'Endocrinologie, Maladies Métaboliques et Nutrition

Amiens, 80054, France

Location

Related Publications (1)

• 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.

  PMID: 24596656 RESULT

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• LALAU J. Daniel, Professor

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: March 16, 2016
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)