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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

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).

Key facts

Study ID: NCT01377844
Run by: Theracos
People needed: 288
Starts: 2011-12-01
Expected to finish: 2013-12-01
Last updated by the study team: 2021-07-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Site 5 — Buena Park, California, United States
Site 4 — Los Angeles, California, United States
Site 3 — Santa Ana, California, United States
Site 1 — Hialeah, Florida, United States
Site 9 — Berlin, New Jersey, United States
Site 7 — Cary, North Carolina, United States
Site 6 — Marion, Ohio, United States
Site 8 — Munroe Falls, Ohio, United States
Site 2 — Portland, Oregon, United States
Site 11 — North Richland Hills, Texas, United States
Site 7 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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