Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: EGT0001442: 20 mg Capsules OD for 98 weeks
Control Intervention1: Placebo
: OD for 98 weeks
Sponsors
Theracos Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female subjects >=18 years old 2.Diagnosed with type 2 diabetes 3.Body mass index(BMI) 4.HbA1c between 7 and 10%(Inclusive) as screening 5.FPG 6.Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent. 7.If taking anti-diabetic medication, dose and regimen must be stable for past 3 months 8.If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months 9.If taking lipid modifying therapy, dose and regimen must be stable for past 3 months 10.Blood glucose level <250 mg/dL based on finger stick blood glucose for all subjects at randomization
Exclusion criteria
Exclusion criteria: 1.Hemoglobinopathy that affects HbA1c measurement 2.Current use of injected therapy for treatment of diabetes(insulin or GLP-1 receptor based therapy) 3.Genitourinary tract infection within 6 weeks of screening 4.Greater than 2 episodes of genitourinary tract infection in the past year 5.History of kidney stones, bladder malfunctioning or other significant risk factor for urinary tract infections 6.eGFR, as calculated by the modification of diet in renal disease study equation(MDRD), 7.Abnormal tests of liver function ALT, AST or bilirubin >= 3x ULN 8.Diagnosis of retinopathy or significant nephropathy (eGFR 9.Uncontrolled hypertension (systolic BP >160 or diastolic BP >95) 10.Not willing to use effective birth control, if female with child bearing potential 11.Life expectancy 12.New York Heart Association(NYHA) class 4 heart failure 13.Sera positive of HCV, HIV, or positive on drug screen 14.Currently participating in another interventional trial 15.Previous treatment with EGT0001442 or EGT0001474 16.Not able to comply with the study scheduled visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial study is to assess the efficacy of EGT0001442 on lowering HbA1cTimepoint: at week 24 compared with Placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change from baseline in HbA1c over timeTimepoint: from week 1 to week 96;To assess the effect of EGT0001442 on body weight compared with placeboTimepoint: at screening, run in period, week 1, 6, 8,10,12,14 and 15.;To assess the safety of EGT0001442 in patients with T2DMTimepoint: from week 1 to week 96;To assess the effect of EGT0001442 on systolic and diastolic BPTimepoint: at screening, run in period, and from week 1 to week 96;To assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association(ADA) target HbA1c of 7% in the EGT0001442 group compared with placeboTimepoint: from week 1 to week 96;To assess the efficacy of EGT0001442 in lowering FPGTimepoint: at weeks 2 and 24 compared with placebo | — |
Countries
Colombia, India, Mexico, United States of America
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed