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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT04126603
Eligibility Criteria:
Inclusion Criteria
* Age 20-90
* Diagnosed with Type 2 diabetes mellitus
* Body Mass Index (BMI) between 25.0-45.0 (both inclusive)
* eGFR ≥ 30 mL/min/1.73 m2 by MDRD
* HbA1C 6.5 - 12.0 %
* Subjects on lifestyle modification alone, or Metformin (0.5-2 grams), insulin, or in combination, in any doses of either Metformin or Insulin for at least 3 months prior to screening. 2 week washout of any other anti-hyperglycemic.
* Ability to provide informed consent (and document informed consent by signature) before any trial-related activities are conducted.
* Additional CVD risk factor such microalbuminuria or proteinuria (as defined by ADA, UACR \> 30 mg/g), hypertension (labile, uncontrolled hypertension or controlled on anti-hypertensives) and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or an ankle brachial index \[the ratio of the systolic blood pressure at the ankle to the systolic blood pressure in the arm\] of less than 0.9, low HDL with hypertriglyceridemia (as defined by NCEP ATP III) , strong family history of CHD (as defined by NCEP ATP III and ATP IV).
* Retinal examination within last 2 years of enrollment, showing no proliferative retinopathy
Exclusion Criteria
* Uncontrolled hyperglycemia with fasting glucose \>300 mg/dL (\>16.6 mmol/L)
* Liver disease with ALT, AST or ALP ≥ x3 ULN
* Known (recent) personal history of cerebral stroke or heart attack (myocardial infarction) within last 6 months
* Personal or family history of medullary thyroid cancer (MTC)
* Personal or family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
* GFR \<30 mL/min/1.73 m2 by MDRD
* Prior surgery with chronic malabsorption (eg, bariatric) within last 1 year
* Clinically significant RBC disorders such as hemoglobinopathies
* Diagnosis of Type 1 diabetes mellitus or history of GAD antibody positive status
* Chronic use of high dose anti-inflammatory drugs for the last 3 months
* Beginning statin medications or change in statin dose within the past 1 month
* Starting use of high-dose steroid medication (100mg hydrocortisone or 40mg prednisone equivalent) within the last 1 month
* History of acute pancreatitis within the past 2 years
* Known or suspected allergy to GLP-1 agonists, excipients, or related products.
* Active smokers, \>5 per day (at present)
* Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
* Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration plus 2 months post treatment (for semaglutide washout).
* Women who are pregnant or breastfeeding
* Chronic or persistent alcohol or drug abuse
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness
* Participation in another trial with an investigational drug within 30 days prior to informed consent.
* Untreated or active hemorrhagic proliferative diabetic retinopathy
Exclusionary Laboratory Findings
* Chronic Kidney Disease (CKD) stage 5 (estimated CrCl less than 15 mL/min)
* Triglycerides \> 500 mg/dL
* Low hematocrit (\<28 Units)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT04126603
Study Brief:
Protocol Section:
NCT04126603