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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theracos
ClinicalTrials.gov Identifier:
NCT01377844
First received: June 13, 2011
Last updated: August 27, 2014
Last verified: August 2014

June 13, 2011
August 27, 2014
December 2011
November 2013   (final data collection date for primary outcome measure)
Changes in Hemoglobin A1c levels at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Changes from basline in HbA1c levels in placebo and treatment group at end of 24 weeks treatment
Changes from basline in Hemoglobin A1c (HbA1c) levels at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Changes from basline in HbA1c levels in placebo and treatment group at end of 24 weeks treatment
Complete list of historical versions of study NCT01377844 on ClinicalTrials.gov Archive Site
  • Changes in systolic and diastolic blood pressure at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from basline in systolic and diastolic blood pressure in placebo and treatment group at 24 weeks treatment
  • Changes in body weight at 24 weeks treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline in body weight in placebo and treatment group at 24 weeks treatment
  • Changes in Hemoglobin A1c level over 96 weeks time [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c level over 96 weeks time in plaebo and treatment group. The treatment group received 24 weeks treatment with EGT0001442.
  • Number of participants with adverse events during 96 weeks time [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events in placebo and treatment group during 96 weeks time
  • Changes from baseline in systolic and diastolic blood pressure at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from basline in systolic and diastolic blood pressure in placebo and treatment group at 24 weeks treatment
  • Changes in body weight at 24 weeks treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline in body weight in placebo and treatment group at 24 weeks treatment
  • Changes in Hemoglobin A1c level over 96 weeks time [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c level over 96 weeks time in plaebo and treatment group. The treatment group received 24 weeks treatment with EGT0001442.
  • Number of participants with adverse events during 96 weeks time [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events in placebo and treatment group during 96 weeks time
Not Provided
Not Provided
 
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: EGT0001442
  • Drug: Placebo
  • Placebo Comparator: EGT0001442
    EGT0001442 20 mg capsule, daily, 96 weeks
    Intervention: Drug: EGT0001442
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377844
THR-1442-C-418
Yes
Theracos
Theracos
Not Provided
Study Director: Mason W Freeman, M.D. Massachusetts General Hospital
Theracos
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP