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Diabetes MellitusPhase 2NCT01377844

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

A Phase 2 study testing EGT0001442 in people with Diabetes Mellitus, run by Theracos at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
EGT0001442
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
11 sitesUnited States
Study dates
Dec 2011to Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Site 9

    Berlin, New Jersey

  • Site 5

    Buena Park, California

  • Site 7

    Cary, North Carolina

  • Site 1

    Hialeah, Florida

  • Site 4

    Los Angeles, California

  • Site 6

    Marion, Ohio

  • Site 8

    Munroe Falls, Ohio

  • Site 11

    North Richland Hills, Texas

  • Site 2

    Portland, Oregon

  • Site 7

    San Antonio, Texas

  • Site 3

    Santa Ana, California

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
EGT0001442, Placebo
Keywords
Diabetes mellitus
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGT0001442Drug

    Also called Bexagliflozin

  • PlaceboDrug

Study groups in NCT01377844
Study groupRoleWhat they receive
EGT0001442ExperimentalEGT0001442 capsule, 20 mg, daily, 96 weeks
Receives: Drug: EGT0001442
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and Week 24

Secondary outcomes (5)

  1. 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

    Measured: Baseline and Week 24

  2. Changes in Body Weight at Week 24

    Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment

    Measured: Baseline and week 24

  3. 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.

    Measured: Baseline and up to 96 weeks

  4. 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

    Measured: 24 weeks

  5. Percentage of Subjects Achieving HbA1c <7%

    The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported

    Measured: Baseline and up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377844
Sponsor's protocol ID
THR-1442-C-418
Status last verified
Jun 2021
First submitted
13 Jun 2011
Last updated
1 Jul 2021
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 21193625

  • 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.

    PubMed 15624123

  • 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.

    PubMed 20566676

  • 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.

    PubMed 18356408

  • 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.

    PubMed 19129748

  • 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.

    PubMed 19129749

  • 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.

    PubMed 20205482

  • 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.

    PubMed 14569097

  • 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.

    PubMed 12436245

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EGT0001442 in people with Diabetes Mellitus, run by Theracos at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c at 24 Weeks (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01377844, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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