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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT02390050
Eligibility Criteria:
The following subjects were eligible for randomization:
1. men or women ≥ 20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test.
2. were treatment naïve or taking one oral anti-diabetic medication in combination with diet and exercise
3. were diagnosed with T2DM with HbA1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with HbA1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication
4. had a body mass index (BMI) ≤ 40 kg/m2
5. were taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)
6. were able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
7. were able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
8. had an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5)
9. were capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
Subjects who exhibited any of the following characteristics were to be ineligible for randomization:
1. Diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
2. Used parenteral therapy for treatment of diabetes
3. Pregnancy or current breastfeeding status
4. Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement
5. Genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening
6. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 at screening.
7. Uncontrolled hypertension at screening
8. A positive result on hepatitis B surface antigen, hepatitis C, or positive result from screen for drugs of abuse
9. History of human immunodeficiency virus infection
10. Life expectancy \< 2 years
11. History of New York Heart Association Class 4 heart failure within 3 months of screening
12. History of myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
13. History of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer
14. Previous treatment with bexagliflozin
15. Had taken or within 6 months of taking any Sodium Glucose Transporter 2 (SGLT2) inhibitors prior to screening
16. Participation of another interventional trial
17. Not able to comply with the study scheduled visits
18. Affected by any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the investigator, would jeopardize the subject's appropriate participation in this study.
19. Liver function tests resulting in Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN, with the exception of isolated Gilbert's syndrome ,at screening
20. Exhibited fasting plasma glucose ≥ 250 mg/dL (13.9 mmol/L) on two or more consecutive days prior to randomization or exhibited severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue
21. Fasting Plasma Glucose ≥ 250 mg/dL at randomization
22. Prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (UACR) \> 2000 mg/g at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02390050
Study Brief:
Protocol Section:
NCT02390050