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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00349427
Eligibility Criteria:
Inclusion:
* Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
* If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level\>7.5%.
Exclusion:
* Fasting plasma glucose \>13 mmol/L at screening
* Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
* Drug abuse
* Women pregnant or lactating
* Use any rosiglitazone like drug in 3 months
* Use more than one oral antidiabetic agent in 2 months
* Uncontrolled hypertension
* Chronic heart failure
* Anemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00349427
Study Brief:
Protocol Section:
NCT00349427