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Trial record 1 of 1 for:    NCT02558296
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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 28, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 22, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bexagliflozin Efficacy and Safety Trial (BEST)
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Bexagliflozin
    20 mg, tablet
    Other Names:
    • EGT0001442
    • EGT0001474
  • Drug: Placebo
    20 mg tablet to match active comparator
Study Arms  ICMJE
  • Active Comparator: Bexagliflozin tablets, 20 mg
    Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
    Intervention: Drug: Bexagliflozin
  • Placebo Comparator: Placebo tablets
    Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 4, 2019)
1700
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
1650
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Denmark,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Taiwan,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02558296
Other Study ID Numbers  ICMJE THR-1442-C-476
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Theracos
Study Sponsor  ICMJE Theracos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: J. Paul Lock, MD Theracos
PRS Account Theracos
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP