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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT05333835
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 18-70 age years, both inclusive;
2. BMI is 20.0 to 40.0 kg/m2, both inclusive;
3. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
4. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
5. At screening:
1\) Treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose \[MTD, ≥1000 mg\]) for ≥3 months, or 2) Treatment with metformin at the above dose level combined with a second OAD (AGI, SU, TZD, glinides, DPP-4i or SGLT2i) on a stable dose (≥half of the max approved dose according to local label, or at the MTD) for ≥3 months.
Exclusion Criteria:
1. Use of systemic glucocorticoids within 3 months prior to the screening;
2. Use of weight loss drugs within 3 months prior to the screening.
3. Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes);
4. Laboratory findings at the screening visit:
* Amylase and/or lipase \>3 x upper limit of normal (ULN);
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 x ULN;
* Moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin;
* Urinary albumin creatinine ratio (UACR) ≥300 mg/g;
* Total bilirubin \>2.0 x ULN;
* Calcitonin ≥50 ng/L;
5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；
6. Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures;
7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
8. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
9. History of pancreatitis (acute or chronic);
10. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05333835
Study Brief:
Protocol Section:
NCT05333835