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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03087032
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 75 years old.
* BMI must be greater than 24 and less than 45 kg/m2
* Patients with type 2 diabetes who met the World Health Organization (who) diagnostic criteria (1999).
* Newly diagnosed type 2 diabetic patients with HbA1c ≥ 9.0%；or patients with uncontrolled type 2 diabetes (HbA1c ≥ 7.5% ) who have received at least two types of oral hypoglycemic drugs (the dose of each drug needs to reach the second largest dose or more), or only insulin (excluding basal-bolus insulin therapy), or insulin with oral hypoglycemic drugs.
* Signed informed consent.
Exclusion Criteria:
* History of pancreatic disease,
* History of medullary thyroid carcinoma
* Lipase level \> 3 times above normal,
* Creatinine clearance ≤ 30 mL/min/1.73m2,
* Evidence in the last 6 months of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty, congestive heart failure (New York Heart Association Functional Classification III-IV), or severe ischemic heart disease.
* Preparation for pregnancy or having been in pregnancy
* Researchers believe that there are any factors that affect assessing subjects' participation in trial.
* Patients unable to cooperate in clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03087032
Study Brief:
Protocol Section:
NCT03087032