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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02429258
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus (T2DM)
* Treated with either stable dose of metformin alone \> or = to 1500mg/day or stable dose of insulin \> or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
* Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
* Body mass index (BMI) \< or = to 45 kg/m2
Exclusion Criteria:
* For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
* For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.
* Use of sulfonylureas during the 8 weeks prior to screening
* Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor
* Ingestion of any medication know to affect glucose metabolism for \>7 consecutive days during the 3 months prior to screening
* Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02429258
Study Brief:
Protocol Section:
NCT02429258