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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT02798757
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures
2. Female and/or male aged 18-70 years. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a safe contraception method is used throughout the study.
3. Uncontrolled type 2 diabetes mellitus (HbA1c \> 7%) on metformin monotherapy (≥ 2000 mg qd or maximum tolerated dose)
4. Stage 1 hypertension (BP 140-159/90-99 mmHg)
Exclusion Criteria:
1. Known primary kidney disease (eGFR \< 60 ml/min)
2. History of cardiovascular disease
3. Type 1 diabetes
4. History of heart failure
5. Diseases that shorten the life expectancy (cancers, degenerative neurological disorders etc.)
6. Pregnancy-lactation
7. Patients with eGFR values lower than 45 ml/min (on repeated measurements) during the study period will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02798757
Study Brief:
Protocol Section:
NCT02798757