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:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT00704795
Eligibility Criteria:
Inclusion Criteria:
* Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
* No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
* BMI \<30 kg/m2
* Normal haemoglobin
* Informed consent
Exclusion Criteria:
* Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
* Known liver disease or affected liver enzymes (ALAT/ASAT \> 2 x upper normal limit)
* Diabetic nephropathy (se-creatinin \> 130 µM and/or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Treatment with medication that cannot be discontinued for 14 hours
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00704795
Study Brief:
Protocol Section:
NCT00704795