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

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ClinicalTrials.gov Identifier: NCT01377844

Recruitment Status : Completed

First Posted : June 21, 2011

Results First Posted : June 16, 2021

Last Update Posted : July 1, 2021

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Theracos

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).

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus	Drug: EGT0001442 Drug: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	288 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	December 2011
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: EGT0001442 EGT0001442 capsule, 20 mg, daily, 96 weeks	Drug: EGT0001442 Other Name: Bexagliflozin
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Hemoglobin A1c at 24 Weeks [ Time Frame: Baseline and Week 24 ]
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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and up to 96 weeks ]
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) [ Time Frame: 24 weeks ]
Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment
Percentage of Subjects Achieving HbA1c <7% [ Time Frame: Baseline and up to 96 weeks ]
The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377844

Locations

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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

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Study Director:	Mason W Freeman, M.D.	Massachusetts General Hospital

Study Documents (Full-Text)

Documents provided by Theracos:

Study Protocol [PDF] February 2, 2011

Statistical Analysis Plan [PDF] November 22, 2011

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

Sicree, R., Shaw, J., and Zimmet, P. (2010). The Global Burden - Diabetes and Impaired Glucose Tolerance (Baker IDI Heart and Diabetes Institute).

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.

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Responsible Party:	Theracos
ClinicalTrials.gov Identifier:	NCT01377844
Other Study ID Numbers:	THR-1442-C-418
First Posted:	June 21, 2011 Key Record Dates
Results First Posted:	June 16, 2021
Last Update Posted:	July 1, 2021
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Theracos:


Diabetes mellitus

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Bexagliflozin Hypoglycemic Agents Physiological Effects of Drugs

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