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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT03851432
Eligibility Criteria:
Inclusion Criteria:
* T2DM Patients with inadequate glycemic control (HbA1c level≥7.0% and ≤10.5% at baseline) on metformin monotherapy.
* Body Mass Index: 18.0\~35.0 kg/m2 (both inclusive)
Exclusion Criteria:
* History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
* More than 10% change in body weight within the 3 months before screening
* Any laboratory test indicators meet the following standards:
* fasting plasma glucose ≥ 15 mmol/L
* aspartate aminotransferase, alanine aminotransferase levels \> 3 times the upper limit of normal (ULN); total bilirubin \> 1.5 times ULN
* hemoglobin \< 100 g/L
* eGFR \< 60 mL/min/1.73m2
* fasting triglycerides \> 5.64 mmol/L (500 mg/dL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03851432
Study Brief:
Protocol Section:
NCT03851432