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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00063128
Eligibility Criteria:
Inclusion Criteria:
* You are at least 18 years old.
* You have had type 1 diabetes for at least 2 years.
* You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
* If you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
* You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.
Exclusion Criteria:
* You have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
* You have a history of asthma or allergies.
* You have a chronic cough.
* You have had a kidney transplant, are on dialysis, or have poor kidney function.
* You have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00063128
Study Brief:
Protocol Section:
NCT00063128