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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT07165158
Eligibility Criteria:
Inclusion Criteria:
1. Type 2 diabetes (according to WHO diagnostic criteria),
2. Age range: 50 to ≦75 years,
3. Glycosylated hemoglobin (HbA1c): 6.5 to ≦9.0%,
4. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -1, or history of fragility fractures (hip, vertebral, distal forearm, or proximal humerus fractures) within three years before screening,
5. No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).
Exclusion Criteria:
1. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -2.5,
2. History of secondary osteoporosis,
3. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2.5 times the upper limit of the normal reference, or estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73㎡),
4. History of malignant tumors,
5. Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,
6. History of pancreatitis or triglyceride levels \>5.6 mmol/L;
7. Family history of medullary carcinoma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT07165158
Study Brief:
Protocol Section:
NCT07165158