Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: EGT0001442; Placebo
Intervention MeSH terms: Bexagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes mellitus

Summary:

      The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated
      Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels
      at 24th week from baseline, when compared to placebo group(no diabetic medication given). The
      secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting
      blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study
      assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American
      Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with
      placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures,
      body weight and compare with the respective placebo groups.This study also assess the change
      from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of
      EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥18 years old

          -  Diagnosed with type 2 diabetes

          -  Body mass index (BMI) ≤ 45 kg/m2

          -  HbA1c between 7 and 10% (inclusive) at screening

          -  FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies
             or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies

          -  Diabetes currently treated with diet and exercise only or diet and exercise along with
             one approved oral anti-diabetic agent

          -  If taking anti-diabetic medication, dose and regimen must be stable for past 3 months

          -  If taking anti-hypertensive medication, dose and regimen must be stable for past 3
             months

          -  If taking lipid modifying therapy, dose and regimen must be stable for past 3 months

          -  Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at
             randomization

        Exclusion Criteria:

          -  Hemoglobinopathy that affects HbA1c measurement

          -  Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor
             based therapy)

          -  Genitourinary tract infection within 6 weeks of screening

          -  Greater than 2 episodes of genitourinary tract infection in the past year

          -  History of kidney stones, bladder malfunction or other significant risk factor for
             urinary tract infections

          -  eGFR, as calculated by the modification of diet in renal disease study equation
             (MDRD), < 50 mL/min/1.73 m2

          -  Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN

          -  Diagnosis of retinopathy or significant nephropathy (eGFR < 50 mL/min/1.73 m2

          -  Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure
             >95)

          -  Not willing to use effective birth control, if female with child-bearing potential

          -  Life expectancy < 2 years

          -  New York Heart Association (NYHA) Class 4 heart failure

          -  Sera positive of HCV, HIV, or positive on drug screen

          -  Currently participating in another interventional trial

          -  Previous treatment with EGT0001442 or EGT0001474

          -  Not able to comply with the study scheduled visits