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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259789
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Drug: Bexagliflozin tablets, 20 mg Drug: Bexagliflozin tablets, placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 21, 2019

Resource links provided by the National Library of Medicine


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

Placebo Comparator: Bexagliflozin tablets, Placebo Drug: Bexagliflozin tablets, placebo
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.




Primary Outcome Measures :
  1. Change in HbA1c from baseline to week 24 [ Time Frame: Baseline and 24 weeks ]

Secondary Outcome Measures :
  1. Change in FPG over time [ Time Frame: Baseline, up to 24 weeks ]
  2. Change in SBP over time [ Time Frame: Baseline, up to 24 weeks ]
  3. Proportion of subjects achieving HbA1c of≤ 7% over time [ Time Frame: Baseline, up to 24 weeks ]
  4. Change in total body weight in subjects with baseline BMI ≥ 25 kg/m2 over time [ Time Frame: Baseline, up to 24 weeks ]
  5. Change in HbA1c over time [ Time Frame: Baseline, up to 24 weeks ]
  6. Change in HbA1c among subjects who have baseline HbA1c of > 10.5% and ≤ 12.0% over time [ Time Frame: Baseline, up to 24 weeks ]

Other Outcome Measures:
  1. Safety of exposure to bexagliflozin for 24 weeks as assessed by analyzing treatment emergent adverse events, laboratory results, electrocardiogram parameters, physical examinations, vital signs and use of concomitant medications [ Time Frame: Baseline, up to 24 weeks ]
  2. Bexagliflozin plasma concentrations over time [ Time Frame: Baseline, week 6 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T2DM
  • Currently taking metformin as the sole anti-diabetic medication
  • Body Mass Index (BMI) ≤ 45 kg/m2

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
  • Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
  • 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): NCT03259789


Locations
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Sponsors and Collaborators
Theracos
Investigators
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Study Director: J, Paul Lock, M.D. Theracos
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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT03259789    
Other Study ID Numbers: THR-1442-C-419
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases