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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02146651
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes mellitus for at least 12 months
* Treated with multiple daily insulin injections of insulin pump for at least 12 months
* Body Mass Index (BMI): 18.5-28.0 Kg.m²
Exclusion Criteria:
* Type 2 diabetes mellitus
* Receipt of any investigational product within 3 months prior first dosing
* Clinically significant abnormalities as judged by the investigator
* Any systemic treatment with drugs known to interfere with glucose metabolism
* History of alcoholism or drug/chemical abuse as per investigator's judgement
* Use of tobacco or nicotine-contained product within 1 year prior to screening
* Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02146651
Study Brief:
Protocol Section:
NCT02146651