Renal Insufficiency, Chronic
Conditions
Keywords
diabetes type 2, Metformin, chronic kidney disease, CKD
Brief summary
There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.
Interventions
DRUGMetformin
Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)
Exclusion criteria
* Pregnancy and lactation * Hyperlactatemia (\> 2.5 mmol/L) * No creatinine levels available since 3 months * Severe hepatic insufficiency * No liver function parameters available * Need of investigation with iodized contrast media * Hypersensitivity to metformin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of once daily Metformin XR on 24-h blood glucose control | week 12 | The blood glucose will be measured continuously throughout the study using continuous glucose monitoring (mean, range and variability in each therapeutic block). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Metformin XR in mild to moderate (CKD) | week 0, 2, 4, 6, 8, 10 and 12 | Blood creatinine levels will be measured at the end of each therapeutic block. (week 0, 2, 4, 6, 8, 10 and 12) |
| Tolerability of Metformin XR in mild to moderate (CKD) 2 | week 0, 2, 4, 6, 8, 10 and 12 | blood lactate levels will be measured at the end of each therapeutic block. |
Countries
France
Outcome results
None listed