Efficacity and safety of metformin extended release (XR) in diabetic patients with CKD in stages 1 to 3 (METXR/CKD)
Phase 1
- Conditions
- type 2 diabetesMedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2016-001233-27-FR
- Lead Sponsor
- CHU Amiens Picardie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Type 2 diabetes patients aged between 18 and 80 years requiring metformin (and any other antidiabetic treatment)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
-Pregancy 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To exhibit the efficacy of once daily Metformin XR on 24-h blood glucose control.;Secondary Objective: To exhibit the tolerability of Metformin XR in mild to moderate (CKD).;Primary end point(s): -2 wk-blood glucose control (mean, range, and variability per treatment block)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Lactate levels <br>-Pharmacokinetic parameters (AUC, …)<br>;Timepoint(s) of evaluation of this end point: 12 weeks