type 2 diabetes MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: metformin extended release
Product Name: metformin extended release
Pharmaceutical Form: Capsule
Sponsors
CHU Amiens Picardie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Lactate levels - Pharmacokinetic parameters (AUC, …) ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
France
Contacts
Public ContactLucie Desjardins
CHU Amiens Picardie
Outcome results
None listed