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 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT00420095
Eligibility Criteria:
Inclusion Criteria:
* Clinically diagnosed type 1or type 2 diabetes for at least 2 months
* Aged between 18 and 70 (inclusive)
* Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
* Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1
* Compliance with diet and insulin therapy and performs regular blood glucose monitoring
Exclusion Criteria:
* Have used oral antidiabetic agents within 30 days prior to entry into the study
* Receive a total daily dose of insulin \>2 units/kilogram
* Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
* Have a body mass index \>35 kilograms per square meter (kg/m2)
* Receive chronic systemic glucocorticoid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00420095
Study Brief:
Protocol Section:
NCT00420095