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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT04218734
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;
* Age 18-75 years, men and women;
* BMI 19-35 kg/m2;
* HbA1c 7.0%-9.5%;
* Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.
* Signed informed consent from the patient;
* Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.
Exclusion Criteria:
* FPG \> 13.9 mmol/L;
* Insulin treatment required in the investigator's opinion;
* Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;
* Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
* Severe hypoglycemia;
* Serious diabetic complications (such as diabetic foot, etc.);
* History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
* History of being allergic to DPP-4 inhibitors;
* Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;
* Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;
* Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 3\*upper limit of normal (ULN), or total bilirubin \> 1.5ULN;
* Abnormal renal function;
* White blood cells (WBC) \< 3.0109/l, neutrophil count of peripheral blood \< 1.5109/l, hemoglobin \< 100g / L, triglyceride \> 5.7 mmol/l;
* HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;
* Pregnant or lactating women;
* History of alcohol or drug abuse;
* Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;
* Significant unstable diseases;
* Any condition that in the investigator's opinion might render the patient unable to participate the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04218734
Study Brief:
Protocol Section:
NCT04218734