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Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes

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: NCT02715258
Recruitment Status : Completed
First Posted : March 22, 2016
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 in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).

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

Detailed Description:
Approximately 210 subjects with inadequately controlled T2DM will be recruited from US and Canada. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 once daily for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Compare the Efficacy and Safety of Bexagliflozin to Placebo in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

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 Name: EGT0001442

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 ]

Secondary Outcome Measures :
  1. Change in systolic blood pressure from baseline to week 24 [ Time Frame: 24 weeks ]
  2. Change in body weight from baseline to week 24 [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. Change from baseline of fasting plasma glucose from baseline up to 24 weeks [ Time Frame: 24 weeks ]
  2. Change from baseline of HbA1c from baseline up to 24 weeks [ Time Frame: 24 weeks ]
  3. Proportion of subjects who achieve an HbA1c < 7% [ Time Frame: Up to 24 weeks ]
  4. Safety of exposure to bexagliflozin for 24 weeks (adverse events) [ Time Frame: 24 weeks ]
    Safety will be assessed based on an analysis of the adverse events record; of laboratory data, including hematology, serum chemistry, urinalysis, urinary electrolytes and creatinine; of electrocardiograms (ECGs), vital signs and physical examinations; and of concomitant medication use. All subjects who are randomized and take at least one dose of double-blind study medication will be included in the Safety Analysis Set. Safety analyses will be based on the medication that was actually dispensed to each subject.

  5. Effect of bexagliflozin on the incidence of adverse events of special interest [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with T2DM
  • Subjects who are not currently taking medication for diabetes or who are taking only one oral medication for diabetes
  • Subjects whose doses of blood pressure or cholesterol medications (if applicable) have not changed for at least 30 days

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
  • Current use of injected therapy for treatment of diabetes (insulin or glucagon-like-peptide-1 receptor agonist therapy) or thiazolidinedione class drugs
  • History of genitourinary tract infections
  • Evidence of abnormal liver function
  • Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
  • Prior kidney transplant or evidence of kidney problems
  • 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): NCT02715258


Locations
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United States, California
Research Site
Canoga Park, California, United States, 91303
Research Site
Chino, California, United States, 91710
Research Site
Huntington Park, California, United States, 90255
Research Site
Los Angeles, California, United States, 90057
Research Site
San Diego, California, United States, 92103
United States, Florida
Research Site
Fort Lauderdale, Florida, United States, 33316
Research Site
Hialeah, Florida, United States, 33012
Research Site
Miami Lakes, Florida, United States, 33016
Research Site
Orlando, Florida, United States, 32806
Research Site
Port Orange, Florida, United States, 32127
United States, New Jersey
Research Site
Trenton, New Jersey, United States, 08611
United States, North Carolina
Research Site
Calabash, North Carolina, United States, 28467
Research Site
Morehead City, North Carolina, United States, 28557
United States, Ohio
Research Site
Munroe Falls, Ohio, United States, 44262
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, South Carolina
Research Site
North Myrtle Beach, South Carolina, United States, 29582
United States, Texas
Research Site
DeSoto, Texas, United States, 75115
Research Site
Fort Worth, Texas, United States, 76164
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V6J 1S3
Canada, Ontario
Research Site
Newmarket, Ontario, Canada, L3Y 5G8
Research Site 2
Toronto, Ontario, Canada, M9V 4B4
Research Site 1
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Research Site
Pointe-Claire, Quebec, Canada, H9R 4S3
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: NCT02715258    
Other Study ID Numbers: THR-1442-C-450
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases