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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT01135927
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
* Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
Exclusion Criteria:
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01135927
Study Brief:
Protocol Section:
NCT01135927