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Bexagliflozin Efficacy and Safety Trial (BEST) (BEST)

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ClinicalTrials.gov Identifier: NCT02558296
Recruitment Status : Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Brief Summary:

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events.

The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Bexagliflozin Drug: Placebo Phase 3

Detailed Description:

Approximately 130 investigative sites globally are planned to participate in this study.

An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications.

The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Study to Evaluate the Effects of Bexagliflozin on Hemoglobin A1c in Patients With Type 2 Diabetes and Increased Risk of Cardiovascular Adverse Events
Actual Study Start Date : October 2015
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
Drug: Bexagliflozin
20 mg, tablet
Other Names:
  • EGT0001442
  • EGT0001474

Placebo Comparator: Placebo tablets
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
Drug: Placebo
20 mg tablet to match active comparator




Primary Outcome Measures :
  1. Change in HbA1c from baseline to week 24 [ Time Frame: 24 weeks ]
    The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events.


Secondary Outcome Measures :
  1. Change in body weight from baseline to week 48 [ Time Frame: 48 weeks ]
    To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo

  2. Change in systolic blood pressure from baseline to week 24 [ Time Frame: 24 weeks ]
    To evaluate the effect of 20 mg bexagliflozin on the change in systolic blood pressure (SBP) from baseline to week 24 in subjects with baseline systolic blood pressure ≥ 140 mmHg compared to placebo


Other Outcome Measures:
  1. Change in HbA1c over time [ Time Frame: Duration of study ]
    To assess the effect of 20 mg bexagliflozin treatment on the change in HbA1c versus placebo over time

  2. Change in fasting plasma glucose over time [ Time Frame: Duration of study ]
    To evaluate the effect of bexagliflozin treatment on the change in fasting plasma glucose (FPG) versus placebo over time

  3. Proportion of subjects requiring an intensification of anti-diabetic regimen over time [ Time Frame: Duration of study ]
    To measure the proportion of subjects requiring an intensification of anti-diabetic regimen versus placebo over time

  4. Proportion of subjects requiring a relaxation of their anti-diabetic regimen over time [ Time Frame: Duration of study ]
    To measure the proportion of subjects requiring a relaxation of their anti-diabetic regimen versus placebo over time

  5. Incidence of hospitalization for heart failure [ Time Frame: Duration of study ]
    To measure the incidence of hospitalization for heart failure among all subjects and among subjects who have a history of heart failure at baseline

  6. Evaluation of the safety of exposure to bexagliflozin for a minimum of 52 weeks [ Time Frame: At least 52 weeks ]
    An additional safety objective will be to evaluate the safety of exposure to bexagliflozin for a minimum of 52 weeks in a treatment population that is at elevated risk for major adverse cardiovascular events.

  7. Bexagliflozin plasma concentration over time for population pharmacokinetics study [ Time Frame: 12 weeks ]
    As part of an additional pharmacokinetic study, measurement of bexagliflozin plasma concentration as a function of time from dosing (sparsely sampled) will be conducted at 30 sites and will include approximately 240 subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of T2DM
  • Subjects who have had a stable treatment regimen for T2DM for the past 3 months
  • Subjects who present with at least one of the following 3 histories:

Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
  • History of genitourinary tract infections
  • Evidence of abnormal liver function
  • History of MI, stroke or hospitalization for heart failure in the past 3 months
  • Prior kidney transplant or evidence of kidney problems
  • Prior or planned pace maker implantation
  • Pregnant or nursing

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): NCT02558296


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Sponsors and Collaborators
Theracos
Investigators
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Study Director: J. Paul Lock, MD Theracos

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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT02558296     History of Changes
Other Study ID Numbers: THR-1442-C-476
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases