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

NCT ID: NCT01377844

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-12-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EGT0001442

EGT0001442 capsule, 20 mg, daily, 96 weeks

Group Type: EXPERIMENTAL

EGT0001442

Intervention Type: DRUG

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

EGT0001442

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Bexagliflozin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theracos

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mason W Freeman, M.D.

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

Site 5

Buena Park, California, United States

Site 4

Los Angeles, California, United States

Site 3

Santa Ana, California, United States

Site 1

Hialeah, Florida, United States

Site 9

Berlin, New Jersey, United States

Site 7

Cary, North Carolina, United States

Site 6

Marion, Ohio, United States

Site 8

Munroe Falls, Ohio, United States

Site 2

Portland, Oregon, United States

Site 11

North Richland Hills, Texas, United States

Site 7

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21193625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15624123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20566676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18356408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19129748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19129749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20205482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14569097 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12436245 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

THR-1442-C-418

Identifier Type: -

Identifier Source: org_study_id