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

NCT01377844 | Completed Phase 2 Results DMC

• 1 other identifier: THR-1442-C-418
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 11

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).

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and Week 24

Secondary Outcomes (5)

• Changes in Systolic and Diastolic Blood Pressure at Week 24

  Baseline and Week 24

• Changes in Body Weight at Week 24

  Baseline and week 24

• Change From Baseline in HbA1c Over 96 Weeks Time

  Baseline and up to 96 weeks

• Change From Baseline Over Time in Fasting Plasma Glucose (FPG)

  24 weeks

• Percentage of Subjects Achieving HbA1c <7%

  Baseline and up to 96 weeks

Study Arms (2)

EGT0001442

EXPERIMENTAL

EGT0001442 capsule, 20 mg, daily, 96 weeks

Drug: EGT0001442

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EGT0001442 DRUG

Also known as: Bexagliflozin

EGT0001442

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theracos: lead

Study Sites (11)

Site 5

Buena Park, California, United States

Location

Site 4

Los Angeles, California, United States

Location

Site 3

Santa Ana, California, United States

Location

Site 1

Hialeah, Florida, United States

Location

Site 9

Berlin, New Jersey, United States

Location

Site 7

Cary, North Carolina, United States

Location

Site 6

Marion, Ohio, United States

Location

Site 8

Munroe Falls, Ohio, United States

Location

Site 2

Portland, Oregon, United States

Location

Site 11

North Richland Hills, Texas, United States

Location

Site 7

San Antonio, Texas, United States

Location

Related Publications (10)

• 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.

  PMID: 21193625 BACKGROUND

• 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.

  PMID: 15624123 BACKGROUND

• 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.

  PMID: 20566676 BACKGROUND

• 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.

  PMID: 18356408 BACKGROUND

• 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.

  PMID: 19129748 BACKGROUND

• 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.

  PMID: 19129749 BACKGROUND

• 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.

  PMID: 20205482 BACKGROUND

• 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.

  PMID: 14569097 BACKGROUND

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

  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.

  PMID: 12436245 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

bexagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Albert Collinson, Ph.D.
• Organization: Theracos Sub, LLC

acollinson@theracos.com

(508) 688-4221

Study Officials

• Mason W Freeman, M.D.

  Massachusetts General Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 21, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 1, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)