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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT03608358
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent before participating in the study
2. Diagnosed with type 2 diabetes mellitus
3. Inadequate glycemic control defined as below:
* HbA1c ≥ 8.0% and ≤ 11.5% for Stratum A and HbA1c ≥ 7.5% and ≤ 10.5% for Stratum B at screening visit
* HbA1c ≥ 7.0 and ≤ 10.5% for both strata at Week -2 visit
4. Body mass index ≤ 40.0 kg/m\^2
Exclusion Criteria:
1. Women of childbearing potential unable or unwilling to use acceptable birth control, or women who are pregnant or breastfeeding
2. History of diabetes insipidus and type 1 diabetes
3. History of diabetic ketoacidosis requiring medical intervention within 1 month prior to screening
4. Subjects with moderate to severe renal impairment (defined as estimate glomerular filtration rate calculated by the MDRD Formula \< 60mL/min/1.73 m\^2 or serum creatinine ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females) or end-stage renal disease
5. History of unstable or rapidly progressing renal disease
6. Subjects with significant hepatic disease or severe hepatic impairment, or positive serologic evidence of current infectious liver disease
7. Prohibited Treatment and Therapies
* Administration of any anti-hyperglycemic therapy \[other than metformin, or Dipeptidyl peptidase-4 (DPP-4) inhibitors\] for more than 14 days (consecutive or not) during the 8 weeks prior to screening
* Any use of Sodium glucose cotransporter 2 (SGLT2) inhibitor within 8 weeks prior to screening
* Prescription and over-the-counter weight loss medications within 3 months prior to screening
* Current treatment with potent cytochrome P450 3A4/5 inhibitors
8. Malignancy within 5 years of the screening
9. History of hemoglobinopathy
10. Hematuria (by microscopy) positive at screening visit
11. FPG \> 270 mg/dL obtained at open-label period
12. An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT03608358
Study Brief:
Protocol Section:
NCT03608358