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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT05343767
Eligibility Criteria:
Inclusion Criteria:
1. Able and willing to provide written informed consent.
2. Males and females aged between 18 and 65 years of age.
3. Newly diagnosed with type II diabetes mellitus patients as per the following criteria (FBG ≥ 126 mg/dl) or, 2h- post prandial ≥ 200 mg/dl during OGTT or, HbA1c ≥ 6.5%
4. Anti-diabetic treatment naïve patients.
5. Able and willing to perform SMBG and to complete subject diaries.
Exclusion Criteria:
1. Pregnant or lactating women; women of childbearing potential must agree to use an accepted method of contraception during the course of the study and for 1 month after their last dose of study drug.
2. Patients with BMI \> 40 Kg/m2 or BMI \< 18.5 Kg/m2.
3. eGFR \<60 mL/min/1.73 m2 (measured by the CKD-EPI equation) 3.
4. History of Positive human immunodeficiency virus, hepatitis B surface antigen (HBsAG), or hepatitis C antibody test.
5. History of type I diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's syndrome or acromegaly.
6. History of diabetic complications such as diabetic ketoacidosis, lactic acidosis or state of hyperosmolar hyperglycemia, diabetic proliferative retinopathy, or severe diabetic neuropathy (requiring treatment with antidepressants or opioids) and history of decompensated diabetes (polyuria, polydipsia, nocturia, fatigue).
7. History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data.
8. History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding.
9. History of an eating disorder (e.g., bulimia, anorexia).
10. History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to screening.
11. History of significant cardiovascular disease (such as congestive heart failure, myocardial infarction, coronary disease) or uncontrolled hypertension.
12. History of clinically significant renal or liver disease.
13. Receipt of an investigational drug within 30 days prior to screening, or active enrollment in another investigational medication or device trial.
14. Known or suspected allergy to the trial products.
15. Any condition, in the judgment of the investigator, that would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05343767
Study Brief:
Protocol Section:
NCT05343767