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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03029351
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes for at least 1 year.
* Microalbuminuria for at least 6 months (UACR: 30-300 mg/g)
* Macroalbuminuria for at least 6 months (UACR: \>300 mg/g)
* HbA1c of ≤10%
* Ages 18-65 years (inclusive of ages 18 and 65)
* On ARBs/ACEi for at \>3months
Exclusion Criteria:
* Use of GLP-1 Receptor agonists or SGLT-2 inhibitors therapy in the last 3 months
* History or risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia)
* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months
* Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as:
1. Aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
2. Total bilirubin \>2.0 mg/dL (34.2 µmol/L)
3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
4. Liver function tests more than 3 times the upper limit of normal
* Renal impairment (serum eGFR \<30 ml/min)
* HIV
* Inability to give informed consent
* History of gastroparesis
* History of medullary thyroid carcinoma or MEN 2 syndrome
* Alcoholism
* Hypertriglyceridemia (\>500 mg/dl).
* Any other life-threatening, non-cardiac disease
* Uncontrolled hypertension (BP \> 160/100 mm of Hg)
* Congestive Heart Failure class III or IV
* Use of an investigational agent or therapeutic regimen within 30 days of study
* Participation in any other concurrent clinical trial
* Pregnant or breastfeeding patients or females of childbearing age not on 2 forms of acceptable contraceptives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03029351
Study Brief:
Protocol Section:
NCT03029351