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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT04357392
Eligibility Criteria:
Inclusion Criteria:
1. The diagnosis of type 2 diabetes was in accordance with the WHO diagnostic criteria of diabetes in 1999:fasting blood glucose ≥ 7.0mmol/l and / or blood glucose ≥ 11.1mmol/l in 2 hours after OGTT
2. Aged between 30-60 years
3. Positive detection of insulin antibody, hyperinsulinemia (refer to WHO standard in 1999, fasting insulin \> 15 μ IU / ml or 2h postprandial insulin \> 80 μ IU / ml)
4. Type 2 diabetes mellitus patients who receiving insulin therapy
5. Those meeting all the above standards can be included
Exclusion Criteria:
1. Patients who had used animal insulin before the study
2. Type 1 diabetes, gestational diabetes and special type diabetes
3. Diabetic acute complications (ketoacidosis, hyperosmotic nonketotic coma, lactic acidosis) or serious chronic complications ; serious chronic complications (proliferative retinopathy, foot ulcer or gangrene, Complications of heart, brain and kidney)
4. Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease
5. Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis
6. Patients who are using or need to use thiol containing drugs in the near future
7. Patients with severe insulin allergy
8. Glucocorticoid contraindications (severe psychosis and epilepsy, active peptic ulcer or tuberculosis, recent gastrointestinal anastomosis, fracture, wound repair period, corneal ulcer, adrenocortical hyperfunction, severe hypertension, pregnant women, infection beyond the control of antibiotics, such as varicella, mould infection, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT04357392
Study Brief:
Protocol Section:
NCT04357392