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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT00398892
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Age \> 18 years
* Capable of giving informed consent
* Treated with oral antidiabetic agents (not insulin)
* HbA1c 7.0 - 8.5% at last measurement (must be within 6 months of study)
* Most recent HbA1c within 1% of all measurements within preceding year
* Prepared to self-test blood glucose on a regular basis
* Prepared to use contraception during study if of child-bearing potential
Exclusion Criteria:
* Unstable cardiac disease (NYHA class III or IV heart failure, or unstable angina or myocardial infarction within last three months)
* Significant renal or hepatic impairment (creatinine\>170 micromol/L, alanine transaminase or alkaline phosphatase \> 3x upper limit of normal)
* Other medical condition or treatment likely to affect glycaemic control
* Previous history of significant hypoglycaemia
* Pregnancy
* Involvement in other clinical trial in last three months
* Known or suspected sensitivity to trial products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00398892
Study Brief:
Protocol Section:
NCT00398892