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

Theracos

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: EGT0001442; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01377844

THR-1442-C-418

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 288 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 2 patient groups, including a placebo group

EGT0001442

Experimental group

Description:

EGT0001442 capsule, 20 mg, daily, 96 weeks

Treatment:

Drug: EGT0001442

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo