Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

July 6, 2021 updated by: Theracos

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Bexagliflozin in Subjects With Type 2 Diabetes Mellitus Who Are Not Adequately Controlled by Metformin Alone

The purpose of this study is to investigate the effect of bexagliflozin compared to placebo as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 300 subjects with inadequately controlled T2DM on metformin were to be recruited from the United States and Japan. Subjects were randomly assigned to receive bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive open-label bexagliflozin tablets, 20 mg, for 24 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 819-0006
        • Clinical Research Site 6040
      • Kyoto, Japan, 600-8898
        • Clinical Research Site 6043
      • Osaka, Japan, 536-0008
        • Clinical Research Site 6015
      • Tokyo, Japan, 108-0075
        • Clinical Research Site 6045
      • Tokyo, Japan, 166-0003
        • Clinical Research Site 6047
    • Aichi
      • Nagoya, Aichi, Japan, 456-0058
        • Clinical Research Site 6048
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0023
        • Clinical Research Site 6050
    • Ibaraki
      • Koga, Ibaraki, Japan, 306-0232
        • Clinical Research Site 6041
    • Kanagawa
      • Atsugi, Kanagawa, Japan, 243-0035
        • Clinical Research Site 6029
      • Kamakura, Kanagawa, Japan, 547-0055
        • Clinical Research Site 6051
      • Yokohama, Kanagawa, Japan, 221-080
        • Clinical Research Site 6020
    • Meguro
      • Tokyo, Meguro, Japan, 153-0053
        • Clinical Research Site 6055
    • Osaka
      • Higashiosaka, Osaka, Japan, 577-0803
        • Clinical Research Site 6046
      • Kashiwara, Osaka, Japan, 582-0005
        • Clinical Research Site 6033
      • Toyonaka, Osaka, Japan, 560-0082
        • Clinical Research Site 6013
    • Saitama
      • Kawaguchi, Saitama, Japan, 332-0012
        • Clinical Research Site 6052
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0433
        • Clinical Research Site 6053
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Clinical Research Site 1232
      • Birmingham, Alabama, United States, 35242
        • Clinical Research Site 1378
      • Foley, Alabama, United States, 36535
        • Clinical Research Site 1269
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Clinical Research Site 1363
    • California
      • Anaheim, California, United States, 92805
        • Clinical Research Site 1381
      • North Hollywood, California, United States, 91606
        • Clinical Research Site 1375
      • Norwalk, California, United States, 90650
        • Clinical Research Site 1365
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Clinical Research Site 1382
    • Florida
      • Hollywood, Florida, United States, 33024
        • Clinical Research Site 1372
      • Palm Springs, Florida, United States, 33461
        • Clinical Research Site 1362
      • Pembroke Pines, Florida, United States, 33026
        • Clinical Research Site 1373
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Clinical Research Site 1376
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Clinical Research Site 1366
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Clinical Research Site 1294
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Clinical Research Site 1374
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Site 1370
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Clinical Research Site 1009
      • Trenton, New Jersey, United States, 08611
        • Clinical Research Site 1037
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Clinical Research Site 1286
    • New York
      • Bronx, New York, United States, 10455
        • Clinical Research Site 1275
      • New York, New York, United States, 10036
        • Clinical Research Site 1368
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Research Site 1019
    • Texas
      • Gonzales, Texas, United States, 78629
        • Clinical Research Site 1379
      • Houston, Texas, United States, 77051
        • Clinical Research Site 1369
      • San Antonio, Texas, United States, 78209
        • Clinical Research Site 1371
      • San Antonio, Texas, United States, 78258
        • Clinical Research Site 1360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The subjects were required to meet the following criteria at the time of enrollment to be eligible for the study:

  1. Had been age ≥ 20 years at screening. Women of childbearing potential were required to have tested negative for pregnancy and have agreed to abstinence or contraception for the duration of the study to avoid any possible pregnancy. Females who were surgically sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses greater than 12 months) were eligible if they had tested negative for pregnancy at screening.
  2. a) Had a history of T2DM with an HbA1c level of ≥ 7.5% and ≤ 10.5% at screening, or b) Had a history of T2DM with an HbA1c level of >10.5% and ≤ 12.0% at screening
  3. Had been prescribed a stable dose of metformin (≥1500 mg per day in the US or ≥ 1000 mg per day in Japan) as their sole anti-diabetic medication
  4. Had a body mass index (BMI) ≤ 45 kg m-2
  5. Had been able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
  6. Had no recent changes to their medications for hypertension or hyperlipidemia (if applicable)
  7. Had the ability to regularly self-administer medication, as evidenced by consumption of all, or at worst one less than all, doses of run-in medication prior to randomization

Subjects who met any of the following criteria were to be excluded from the study:

  1. Had a diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
  2. Were pregnant or breastfeeding
  3. Had one or more hemoglobin alleles that affect HbA1c measurement
  4. Had a history of genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or a history of ≥ 3 genitourinary infections requiring treatment within 6 months of screening
  5. Had an estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), < 60 mL min-1 per 1.73 m2
  6. Had a sitting systolic blood pressure >180 mmHg or a sitting diastolic blood pressure > 110 mmHg at screening
  7. Had exposure to hypoglycemic agent(s) other than metformin during the 8 weeks prior to screening
  8. Had a history of illicit drug use or alcohol abuse in the past 2 years
  9. Had a life expectancy < 2 years
  10. Had a diagnosis of New York Heart Association (NYHA) Class IV heart failure within 3 months of screening
  11. Had experienced an MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
  12. Had exposure to an investigational drug within 30 days
  13. Had a previous exposure to bexagliflozin or EGT0001474
  14. Had a history of SGLT2 inhibitor treatment
  15. Were participating in another interventional trial
  16. Were not able to comply with the study scheduled visits
  17. Had any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
  18. Had an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × ULN or total bilirubin ≥ 1.5 × ULN at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Bexagliflozin tablets, 20 mg; Double-Blind
Drug: Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
Other Names:
  • EGT0001442, EGT0001474
PLACEBO_COMPARATOR: Bexagliflozin tablets, Placebo; Double Blind
Drug: Bexagliflozin tablets, placebo
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
EXPERIMENTAL: Bexagliflozin Tablets, 20 mg; High Glycemic Group
Drug: Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
Other Names:
  • EGT0001442, EGT0001474

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 24 for Double-blind Group
Time Frame: Baseline to week 24
HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
Baseline to week 24
Change From Baseline in HbA1c at Week 24 for High Glycemic Group
Time Frame: Baseline to week 24
The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24
Baseline to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group
Time Frame: Baseline, up to 24 weeks
FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
Baseline, up to 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group
Time Frame: Baseline, up to 24 weeks
The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24
Baseline, up to 24 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24
Time Frame: Baseline to week 24
Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group
Baseline to week 24
Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group
Time Frame: Baseline, up to 24 weeks
The proportion of subjects who achieved HbA1c < 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.
Baseline, up to 24 weeks
Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group
Time Frame: Baseline, up to 24 weeks
The proportion of subjects who achieved HbA1c < 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.
Baseline, up to 24 weeks
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group
Time Frame: Baseline to week 24
Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.
Baseline to week 24
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group
Time Frame: Baseline to week 24
The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24
Baseline to week 24
Change From Baseline in HbA1c Over Time in Double-blind Treatment Group
Time Frame: Baseline, up to 24 weeks
The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Baseline, up to 24 weeks
Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%
Time Frame: Baseline, up to 24 weeks
The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.
Baseline, up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theracos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: J, Paul Lock, M.D., Theracos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THR-1442-C-419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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