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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02048904
Eligibility Criteria:
Inclusion Criteria:
* Albumin/creatinine ratio between 30-299 mg/dl.
* type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%.
* Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three months prior and during the trial.
* Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more.
* Age between 18-75 years old.
* For women: at least two years postmenopausal, surgically sterile, or using an acceptable contraceptive regiment to include oral contraceptive pill (OCP), intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start.
Exclusion Criteria:
* Pregnancy.
* GFR less than 60 mL/min/73m2.
* Have a history of malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years prior to Visit 1.
* Advanced liver disease.
* Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least 4 months before the study start.
* Psychiatric condition that would prevent subject from following directions. Per PI discretion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02048904
Study Brief:
Protocol Section:
NCT02048904