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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT06881459
Eligibility Criteria:
Inclusion Criteria:
* Body mass index from 19 to 30 kg/m2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%)
* T1D duration of 3-30 years
* C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)
* Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
Exclusion Criteria:
* Anaemia (haemoglobin below normal range)
* Liver disease (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
* Kidney disease (serum creatinine above normal range)
* Late microvascular complications except mild non-proliferative retinopathy
* Regular tobacco smoking or use of other nicotine-containing products
* Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds)
* Pituitary gland disease
* Treatment with any glucose-lowering drugs besides insulin
* Any ongoing medication or physical or psychological condition that the investigator feels would interfere with trial participation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06881459
Study Brief:
Protocol Section:
NCT06881459