Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theracos
• Treatments: Bexagliflozin

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