| Trial ID: | L2419 |
| Source ID: | NCT02710448
|
| Associated Drug: |
Metformin
|
| Title: |
May Metformin be Used in Renal Failure?
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Disorder Associated With Type II Diabetes Mellitus
|
| Interventions: |
DRUG: Metformin
|
| Outcome Measures: |
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|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: 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
|
| Sponsor/Collaborators: |
Sponsor: Centre Hospitalier Universitaire, Amiens | Collaborators: Merck Serono International SA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
82
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-06
|
| Completion Date: |
2015-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-26
|
| Locations: |
Service d'Endocrinologie, Maladies Métaboliques et Nutrition, Amiens, 80054, France
|
| URL: |
https://clinicaltrials.gov/show/NCT02710448
|
