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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT02420392
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes for dapagliflozin arm
* Normal glucose tolerance (fasting plasma glucose \<100 mgd/l, HbA1c \<6.0%) for normal glucose tolerance arm
* Age 18 to 75 years
* BMI \<35 kg/m2
* For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea
Exclusion Criteria:
* Who is allergic to dapagliflozin
* Type 1 diabetes
* Patients with history of diabetic ketoacidosis
* Reduced renal function (eGFR \<60ml/min/1.73m2)
* Taking loop diuretics or dehydrated patient
* History of hypotension when taking hypertensive medication
* Diagnosed with heart failure
* Diagnosed with cerebral infarction
* Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor
* Above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
* Pregnant or breastfeeding women
* History of recurrent genitourinary infection
* AST/ALT more than two fold increased above normal upper limit
* Hemolytic disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02420392
Study Brief:
Protocol Section:
NCT02420392