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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01334151
Eligibility Criteria:
Inclusion Criteria:
Subjects must present with the following:
1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2
2. Diagnosed with type 1 diabetes mellitus for at least 1 year
3. Insulin antibody less than or equal to 10 μU/mL at screening
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
1. Type 2 diabetes mellitus
2. Serum C-peptide \> 1.0 ng/mL
3. HbA1c \> 10.0%
4. History of hypersensitivity to any of the components in the study medication
5. Treatment with any other investigational drug in the last 30 days before screening visit
6. Regular smoking as assessed clinically by the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01334151
Study Brief:
Protocol Section:
NCT01334151