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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01556594
Eligibility Criteria:
Inclusion Criteria:
* History of type 1 diabetes between 2 and 30 years
* Receiving daily insulin injections or insulin pump therapy for at least 2 years
* If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study
* Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2
* Female patients must not be pregnant, and must be using effective contraception.
* Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study
Exclusion Criteria:
* History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study
* Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening
* Presence or history of pheochromocytoma (i.e. adrenal gland tumor)
* Presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease
* Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy
* Known presence of hereditary problems of galactose and /or lactose intolerance
* History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01556594
Study Brief:
Protocol Section:
NCT01556594