May Metformin be Used in Renal Failure?

Renal Disorder Associated With Type II Diabetes Mellitus Clinical Trial

Official title:

May Metformin be Used in Renal Failure?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710448
• Other study ID #: PI11-PR-LALAU-2
• Secondary ID: 2012-001207-20
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2012
• Last updated: April 25, 2016
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Disorder Associated With Type II Diabetes Mellitus
• Renal Insufficiency

Intervention

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)

Locations

Country	Name	City	State
France	Service d'Endocrinologie, Maladies Métaboliques et Nutrition	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Merck Serono International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No