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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00551356
Eligibility Criteria:
Inclusion Criteria:
* Males or females who have type 2 diabetes between 1 and 10 years
* Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
* Have not been on insulin treatment within 3 months before entry into the study
* Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
* Have a body mass index below 40 kg/m²
Exclusion Criteria:
* Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
* Have a known allergy to insulin
* Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
* Have known proliferative retinopathy
* Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00551356
Study Brief:
Protocol Section:
NCT00551356