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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03734718
Eligibility Criteria:
Inclusion Criteria:
* Body mass index between 20 and 27 kg/m2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%)
* Treatment with a stable insulin regimen ≥3 months
* T1D duration between 2 and 15years
* C-peptide negative (C-peptide ≤ 16 ng/ml)
* Informed consent
Exclusion Criteria:
* Anemia (hemoglobin outside normal range)
* Known liver disease and/or ALAT and/or ASAT \> 2 times normal values
* Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
* Prior Cardiovascular events and/or abnormal heart rate/blood pressure
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
* Any physical or psychological condition that the investigator feels would interfere with trial participation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03734718
Study Brief:
Protocol Section:
NCT03734718