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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01459133
Eligibility Criteria:
Inclusion Criteria:
Documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product.
Local Ethics Committee approval has been documented, as needed. Patient has signed the Informed Consent Form for participation. Patient has successfully completed training on the Technosphere Insulin Inhalation System.
Exclusion Criteria:
Allergy to Insulin. Smoking in the previous 6-months. History of asthma or COPD or any other significant pulmonary disease, or exposure to pulmonary toxins.
Clinical significant abnormality in screening laboratory tests. Positive pregnancy test or the intention to become pregnant. Women of childbearing age without appropriate method of contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01459133
Study Brief:
Protocol Section:
NCT01459133