Intervention: Bexagliflozin
Trial phase: Phase 3
ATC code: A10BK08
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(OCCOC4CC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 138
Group description: Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks.
Eligibility criteria:
The study population included:

Male or female adult subjects ≥ 18 years of age at screening
Subjects who were treatment naïve or receiving 1 OHA in combination with diet and exercise
Subjects with a diagnosis of T2DM
Subjects with HbA1c levels at screening between 7.0% and 10.5% (inclusive) if treatment-naïve or with HbA1c levels between 6.5 and 10.0% (inclusive) if on 1 oral anti diabetic agent
Subjects with a BMI ≤ 45 kg/m2
Subjects whose doses of medications for hypertension or hyperlipidemia (if applicable) had not changed for at least 30 days prior to screening
Subjects who were willing and able to return for all clinic visits and to complete all study required procedures
Female subjects of childbearing potential who were willing to use an adequate method of contraception and not become pregnant for the duration of the study.
Subjects who maintained glycemic control throughout washout, if applicable.
Subjects who had HbA1c levels between 7.0 and 10.5% prior to randomization
Subjects who had been compliant in investigational product administration by missing no more than 1 dose of run-in medication

Subjects who met any of the following criteria were excluded from the study:

A diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
Use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs at the time of screening
Female subjects who were pregnant or breastfeeding
Hemoglobinopathy or carrier status for hemoglobin alleles that affected HbA1c measurement
Genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from screening
Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), < 60 mL/min/1.73 m2 at screening
Uncontrolled hypertension defined as a sitting systolic blood pressure >160 mm Hg or diastolic blood pressure > 95 mm Hg at screening
A positive result for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV)
History of alcohol or illicit drug abuse in the past 2 years
Known human immunodeficiency virus (HIV) positive based on medical history
Life expectancy < 2 years
New York Heart Association (NYHA) Class IV heart failure within 3 months of screening
MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
Treatment with an investigational drug within 30 days or within 7 half-lives of the investigational drug, whichever was longer
Previous treatment with bexagliflozin or EGT0001474
Use of any SGLT2 inhibitors, either at the time of screening or in the prior 3 months
Currently participating in another interventional trial
Not able to comply with the study scheduled visits
Any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome at screening
Two or more consecutive FPG measures ≥ 250 mg/dL (13.9 mmol/L) prior to randomization or 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
At last visit prior to randomization, FPG level ≥ 250 mg/dL
Prior renal transplantation or evidence of nephrotic syndrome (defined as a urine albumin-to-creatinine ratio (UACR) > 2000 mg/g at screening).