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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01224366
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of T2DM
* On a stable dose of insulin as defined by the protocol
* On a stable does of metformin (if applicable) as defined by the protocol
* Age 18 to 80 years
* HbA1c of 7.5 to 11.0%
* Body Mass Index (BMI) 22 to 40 kg/m2
Exclusion Criteria:
* Type 1 diabetes
* Short-acting or rapid-acting insulin
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01224366
Study Brief:
Protocol Section:
NCT01224366