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

Study Overview
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Brief Summary
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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).

Detailed Description
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EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels (HbA1c). Due to the increased urinary output, the effect of EGT001442 on blood pressure levels are also assessed.

Official Title
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Efficacy and Safety of EGT0001442 Compared With Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled by Diet and Exercise and up to One Oral Anti-diabetes Agent

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: EGT0001442
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGT0001442<br>EGT0001442 capsule, 20 mg, daily, 96 weeks | Drug: EGT0001442<br> <br> * Other names: Bexagliflozin;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c at 24 Weeks | Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Systolic and Diastolic Blood Pressure at Week 24 | Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment | Baseline and Week 24 | 
| Changes in Body Weight at Week 24 | Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment | Baseline and week 24 | 
| Change From Baseline in HbA1c Over 96 Weeks Time | Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks. | Baseline and up to 96 weeks | 
| Change From Baseline Over Time in Fasting Plasma Glucose (FPG) | Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment | 24 weeks | 
| Percentage of Subjects Achieving HbA1c <7% | The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported | Baseline and up to 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus