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:
NCT05591235
Eligibility Criteria:
Inclusion Criteria:
* Willing to participate in this present study;
* Regular diet and exercise;
* Age 18 to 60 years;
* Screening glycated hemoglobin (HbA1c) \> 9.0%;
* Body mass index (BMI) ≥ 24.0 kg/m2
Exclusion Criteria:
* Other forms of diabetes;
* Insulin allergy or intolerance of metformin, pioglitazone and dapagliflozin;
* Renal dysfunction (estimated glomerular filtration rate \< 45 mL/min);
* Severe liver disease or elevated transaminases (2.5-fold the upper limit);
* History of alcohol dependence or drug abuse in the past 5 years;
* Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
* Acute infection or stress state 1 month prior to this study;
* Pregnancy or lactation;
* History of diabetic ketoacidosis (DKA) within the previous year;
* Psychiatric disease;
* Other comorbid serious condition including severe heart and pulmonary disease, heart failure of New York Heart Association class IV, and tumors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05591235
Study Brief:
Protocol Section:
NCT05591235