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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03919656
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75.
* BMI 27-39.9 kg/m2.
* T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).
Exclusion Criteria:
* Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
* Breastfeeding
* Intolerance/allergy to dapagliflozin.
* Treatment with antidiabetic drug other than metformin.
* Impaired kidney function: Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
* Patients with established cardiovascular disease.
* Previous or current history of cancer of any kind.
* Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).
* History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels\> 2.0 mg / dl or GOT/GPT levels three times higher than normal upper limit.
* Known HIV infection or active HBV or HCV infection.
* Other serious underlying diseases, which could affect the patient's ability to participate in the study.
* Reduced life expectancy (\<12 months) due to advanced or terminal concomitant diseases.
In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03919656
Study Brief:
Protocol Section:
NCT03919656