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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT02719132
Eligibility Criteria:
Inclusion Criteria:
For inclusion in the study patients should fulfil ALL the criteria listed below:
1. A voluntary informed consent form for participation in the study signed by the patient prior to any study-specific procedures
2. Male and female patients of 18-74 years of age
3. Diagnosed type 2 diabetes
4. Therapy with metformin at a stable dose ≤1,500 mg/day for at least 8 weeks before enrolment
5. HbA1c \>7.0% and ≤10% at the Screening Visit
6. C-peptide ≥1.0 ng/ml at the Screening Visit
7. Body mass index ≤45.0 kg/m² at the Screening Visit
8. For women of childbearing potential - use of reliable birth control methods
9. Ability to complete study-specific procedures
10. Ability to complete questionnaires
Exclusion Criteria:
1. Type 1 diabetes
2. Diabetic ketoacidosis at Screening
3. AST and/or ALT \> 3 × upper limit of normal at Screening
4. Total serum bilirubin \> 34.19 μmol/l at Screening
5. Decompensated diabetes mellitus (HbA1c \>10% at Screening)
6. Patients with moderate to severe renal impairment (CrCl \<60 ml/min or \<60 ml/min/1.73 m2 at Screening) or terminal renal insufficiency
7. Severe concomitant diseases or severe cardiovascular, renal, hepatic, hematologic, endocrine, mental or rheumatic pathology
8. Malignancy within 5 years before enrolment
9. Acute (including viral and infectious) diseases within 1 month before the Screening Visit.
10. Development of severe acute diseases during the study which significantly affect the benefit/risk ratio for the subject or affecting study efficacy/safety assessment criteria
11. History of acute myocardial infarction or stroke within 6 months before the Screening Visit or during the study. Heart failure (NYHA III-IV)
12. Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the Screening Visit.
13. For women of childbearing potential - a positive pregnancy test or the patient is breast-feeding or planning pregnancy during the study
14. History of Hepatitis B and C or HIV
15. Individual hypersensitivity to any component of the investigational product (dapagliflozin)
16. Treatment with sodium-dependent glucose cotransporter inhibitors (SGLT2) has been administered within 3 months prior to enrolment or is planned during the study.
17. Loop diuretics have been administered for 3 months before the Screening Visit or are planned during the study.
18. Hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption
19. The patient is unable to follow study procedures and attend the study centre for scheduled study visits or is going to relocate within the protocol-specific timelines
20. The patient is a subject of other studies within 3 months before enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT02719132
Study Brief:
Protocol Section:
NCT02719132