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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01217892
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures
* Diagnosis of T2DM
* Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
* HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.
Exclusion Criteria:
* Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
* History of diabetic ketoacidosis
* Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
* FPG \>270 mg/dL (\>15.0 mmol/L)
* BMI \>45 kg/m2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
77 Years
Study:
NCT01217892
Study Brief:
Protocol Section:
NCT01217892