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

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EGT0001442
Placebo
Sponsored by
Theracos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Site 5
  • Site 4
  • Site 3
  • Site 1
  • Site 9
  • Site 7
  • Site 6
  • Site 8
  • Site 2
  • Site 11
  • Site 7

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EGT0001442

Placebo

Arm Description

EGT0001442 capsule, 20 mg, daily, 96 weeks

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c at 24 Weeks
Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment

Secondary Outcome Measures

Changes in Systolic and Diastolic Blood Pressure at Week 24
Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment
Changes in Body Weight at Week 24
Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment
Change From Baseline in HbA1c Over 96 Weeks Time
Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks.
Change From Baseline Over Time in Fasting Plasma Glucose (FPG)
Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment
Percentage of Subjects Achieving HbA1c <7%
The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported

Full Information

First Posted
June 13, 2011
Last Updated
June 29, 2021
Sponsor
Theracos
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1. Study Identification

Unique Protocol Identification Number
NCT01377844
Brief Title
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theracos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGT0001442
Arm Type
Experimental
Arm Description
EGT0001442 capsule, 20 mg, daily, 96 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
EGT0001442
Other Intervention Name(s)
Bexagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c at 24 Weeks
Description
Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Changes in Systolic and Diastolic Blood Pressure at Week 24
Description
Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment
Time Frame
Baseline and Week 24
Title
Changes in Body Weight at Week 24
Description
Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment
Time Frame
Baseline and week 24
Title
Change From Baseline in HbA1c Over 96 Weeks Time
Description
Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks.
Time Frame
Baseline and up to 96 weeks
Title
Change From Baseline Over Time in Fasting Plasma Glucose (FPG)
Description
Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment
Time Frame
24 weeks
Title
Percentage of Subjects Achieving HbA1c <7%
Description
The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported
Time Frame
Baseline and up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mason W Freeman, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Site 5
City
Buena Park
State/Province
California
Country
United States
Facility Name
Site 4
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 3
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 1
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Site 9
City
Berlin
State/Province
New Jersey
Country
United States
Facility Name
Site 7
City
Cary
State/Province
North Carolina
Country
United States
Facility Name
Site 6
City
Marion
State/Province
Ohio
Country
United States
Facility Name
Site 8
City
Munroe Falls
State/Province
Ohio
Country
United States
Facility Name
Site 2
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 11
City
North Richland Hills
State/Province
Texas
Country
United States
Facility Name
Site 7
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21193625
Citation
American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc11-S011. No abstract available.
Results Reference
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PubMed Identifier
15624123
Citation
Ehrenkranz JR, Lewis NG, Kahn CR, Roth J. Phlorizin: a review. Diabetes Metab Res Rev. 2005 Jan-Feb;21(1):31-8. doi: 10.1002/dmrr.532.
Results Reference
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PubMed Identifier
20566676
Citation
Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. 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. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.
Results Reference
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PubMed Identifier
18356408
Citation
Han S, Hagan DL, Taylor JR, Xin L, Meng W, Biller SA, Wetterau JR, Washburn WN, Whaley JM. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes. 2008 Jun;57(6):1723-9. doi: 10.2337/db07-1472. Epub 2008 Mar 20.
Results Reference
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PubMed Identifier
19129748
Citation
Komoroski B, Vachharajani N, Boulton D, Kornhauser D, Geraldes M, Li L, Pfister M. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009 May;85(5):520-6. doi: 10.1038/clpt.2008.251. Epub 2009 Jan 7.
Results Reference
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PubMed Identifier
19129749
Citation
Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7. Erratum In: Clin Pharmacol Ther. 2009 May;85(5):558.
Results Reference
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PubMed Identifier
20205482
Citation
Neumiller JJ, White JR Jr, Campbell RK. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs. 2010 Mar 5;70(4):377-85. doi: 10.2165/11318680-000000000-00000.
Results Reference
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PubMed Identifier
14569097
Citation
Santer R, Kinner M, Lassen CL, Schneppenheim R, Eggert P, Bald M, Brodehl J, Daschner M, Ehrich JH, Kemper M, Li Volti S, Neuhaus T, Skovby F, Swift PG, Schaub J, Klaerke D. Molecular analysis of the SGLT2 gene in patients with renal glucosuria. J Am Soc Nephrol. 2003 Nov;14(11):2873-82. doi: 10.1097/01.asn.0000092790.89332.d2.
Results Reference
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Citation
Sicree, R., Shaw, J., and Zimmet, P. (2010). The Global Burden - Diabetes and Impaired Glucose Tolerance (Baker IDI Heart and Diabetes Institute).
Results Reference
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PubMed Identifier
12436245
Citation
van den Heuvel LP, Assink K, Willemsen M, Monnens L. Autosomal recessive renal glucosuria attributable to a mutation in the sodium glucose cotransporter (SGLT2). Hum Genet. 2002 Dec;111(6):544-7. doi: 10.1007/s00439-002-0820-5. Epub 2002 Sep 27.
Results Reference
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Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus

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