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
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus
Drug: EGT0001442
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Theracos:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 288
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: EGT0001442
EGT0001442 20 mg capsule, daily, 96 weeks
Drug: EGT0001442
Placebo Comparator: Placebo
Placebo
Drug: Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377844

Locations
United States, California
Site 5
Buena Park, California, United States
Site 4
Los Angeles, California, United States
Site 3
Santa Ana, California, United States
United States, Florida
Site 1
Hialeah, Florida, United States
United States, New Jersey
Site 9
Berlin, New Jersey, United States
United States, North Carolina
Site 7
Cary, North Carolina, United States
United States, Ohio
Site 6
Marion, Ohio, United States
Site 8
Munroe Falls, Ohio, United States
United States, Oregon
Site 2
Portland, Oregon, United States
United States, Texas
Site 11
North Richland Hills, Texas, United States
Site 7
San Antonio, Texas, United States
Sponsors and Collaborators
Theracos
Investigators
Study Director: Mason W Freeman, M.D. Massachusetts General Hospital
  More Information

Publications:
ADA (2011). Standards of medical care in diabetes--2011. Diabetes Care 34 Suppl 1, S11-61.
Ehrenkranz, J.R., Lewis, N.G., Kahn, C.R., and Roth, J. (2005). Phlorizin: a review. Diabetes Metab Res Rev 21, 31-38.
Ferrannini, E., Ramos, S.J., Salsali, A., Tang, W., and List, J.F. (2010). Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 33, 2217-2224.

Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT01377844     History of Changes
Other Study ID Numbers: THR-1442-C-418
Study First Received: June 13, 2011
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Mexico: Ethics Committee
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Theracos:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014