Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention 1 After wash-out (6-10wks)and run-in period (2wks) or run-in period (2wks) only, 12wks of treatment with study drug (Placebo)
Intervention 2 After wash-out (6-10wks)and run-in perio
Sponsors
Theracos, Sub., LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women =>20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test and agree to abstain from coitus or use contraception during the entire study period to avoid any possible pregnancy. Females who are surgically sterile (by reason of hysterectomy or oophorectomy) or postmenopausal (most recent menses more than 12 months prior to screening) are eligible if they test negative by urine pregnancy test. 2. Treatment na&iuml;ve (i.e., have never received prescription anti-diabetic medications or have received no more than 14 days of prescription medications for diabetes in the 12 weeks prior to enrollment) or currently taking one OHA in combination with diet and exercise 3. Diagnosed with T2DM with HbA1c levels at screening between 7.0% and 8.5% (inclusive) if treatment na&iuml;ve or with HbA1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication 4. Currently having a body mass index (BMI) =< 40 kg/m2 5. Taking stable doses of medication for hypertension or hyperlipidemia as determined by adherence to a regimen that has not changed for at least 30 days prior to screening (if applicable) 6. Able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines 7. Able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout) 8. Having an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5) 9. Capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
Exclusion criteria
Exclusion criteria: 1.A diagnosis of type 1 diabetes mellitus or maturity onset diabetes of the young (MODY) 2.Current use of parenteral therapy for treatment of diabetes (insulin or glucagon-like peptide-1 (GLP-1) receptor agonist therapy) 3.Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement 4.Genitourinary tract infection (e.g. urinary tract infection, vaginitis, balanitis) within 6 weeks of screening or history of =>genitourinary infections requiring treatment within 6 months of screening 5.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 (Appendix 2) 6.Uncontrolled hypertension (average of two sitting measurements of systolic blood pressure >160 mmHg or diastolic blood pressure > 95 mmHg) at screening 7.History of New York Heart Association (NYHA) Class 4 heart failure within 3 months of screening 8.History of MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening 9.History of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer 10.Previous treatment with bexagliflozin or EGT0001474 11.Currently or within 6 months of taking any SGLT2 inhibitors from screening 12.ALT or 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 13.Exhibiting fasting plasma glucose=> 250 mg/dL (13.9 mmol/L) on two or more consecutive days prior to randomization or exhibiting 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 14.FPG =>250 mg/dL at randomization 15.Prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (UACR) > 2000 mg/g at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c over 12 weeks of treatment | — |
Countries
Japan,North America
Contacts
Public ContactYoshitaka Ando
Integraed Development Associates k.k Clinical and Regulatory Operation
Outcome results
None listed