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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT02106104
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 2 diabetes (HbA1c: 6.5-9.0% DCCT or 48-75 mmol/mol IFCC)
* Metformin monotherapy; using a stable dose for at least 3 months prior to inclusion
* Both genders (females must be post-menopausal)
* Caucasian
* Age: 35-75 years
* Body Mass Index: \>25 kg/m2
* All patients with previously diagnosed hypertension should use a RAS-interfering agent (angiotensin converting enzyme inhibitor/angiotensin II receptor blocker) for at least 3 months
Exclusion Criteria:
* Current / chronic use of the following medication: thiazolidinediones, insulin, glucocorticoids, immune suppressants, antimicrobial agents or chemotherapeutics. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study
* Chronic use of NSAIDs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications. However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
* Pregnancy
* Frequent occurrence of (confirmed) hypoglycemia (plasma glucose \<3.9 mmol/L)
* Estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
* Current urinary tract infection and active nephritis
* Recent (\<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke, transient ischemic neurologic disorder
* Complaints compatible with or established gastroparesis and/or neurogenic bladder
* Active liver disease
* History of or actual pancreatic disease
* History of or actual malignancy (except for basal cell carcinoma)
* History of or actual severe mental disease
* Substance abuse (alcohol: defined as \>4 units/day; smoking/nicotine: defined as daily smoking/use)
* Allergy to any of the agents used in the study
* Inability to understand the study protocol or give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02106104
Study Brief:
Protocol Section:
NCT02106104