Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT03269058
Eligibility Criteria:
Inclusion Criteria:
* persons who have provided written consent
* type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
* Stable treatment for 3 months
* HbA1c between 7.5% and 10%
* Age between 30 and 65 years
* BMI between 25 and 35 kg/m²
* Triglycerides \< 300 mg/dl
* Half of the patients being treated with statins
* eGFR \> 75 ml/min/1.73 m² at inclusion
Exclusion Criteria:
* persons without national health insurance cover
* patients treated with Insulin or a GLP-1 agonist
* Patients under guardianship
* patients treated with lipid-lowering drugs (except statins for 50% of patients)
* kidney failure
* liver failure or abnormal liver function ASAT or ALAT \>3 x upper limit of normal
* total bilirubin \>2mg/dl
* intestinal disease
* serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
* Pregnancy, breastfeeding
* hypersensitivity to the active substance or to excipients
* patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
* patients treated with loop diuretics or thiazides
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT03269058
Study Brief:
Protocol Section:
NCT03269058