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

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ClinicalTrials.gov Identifier: NCT02769481
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Brief Summary:
The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride 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
Type 2 Diabetes Mellitus Drug: Bexagliflozin Drug: Placebo for Bexagliflozin Drug: Glimepiride Drug: Placebo for Glimepiride Phase 3

Detailed Description:
Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bexagliflozin
Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study.
Drug: Bexagliflozin
20 mg, tablet
Other Name: EGT0001442, EGT0001474

Drug: Placebo for Glimepiride
2, 4 or 6 mg inactive capsule to match the active comparator

Active Comparator: Glimepiride
Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
Drug: Placebo for Bexagliflozin
20 mg inactive tablet to match active comparator

Drug: Glimepiride
2, 4 or 6 mg, capsule




Primary Outcome Measures :
  1. Change in HbA1c from baseline to week 60 [ Time Frame: Baseline and 60 weeks ]

Secondary Outcome Measures :
  1. Change in body weight from baseline to week 60 in subjects with baseline body mass index (BMI) ≥ 25 kg/m2 [ Time Frame: Baseline and 60 weeks ]
  2. Change in systolic blood pressure (SBP) from baseline to week 60 in subjects with baseline SBP ≥ 140 mmHg [ Time Frame: Baseline and 60 weeks ]
  3. Difference in proportion of subjects with ≥ 1 severe or documented symptomatic hypoglycemia events over 96 weeks [ Time Frame: During the 96 week treatment period ]
  4. Change in HbA1c from baseline at week 60 [ Time Frame: During the 60 week treatment period ]

Other Outcome Measures:
  1. Safety of exposure to bexagliflozin for 96 weeks as assessed by analyzing treatment emergent adverse events, laboratory results, electrocardiogram parameters, physical examinations, vital signs and use of concomitant medications [ Time Frame: 96 weeks ]
  2. Effect of bexagliflozin on the incidence of adverse events of interest [ Time Frame: 96 weeks ]


Information from the National Library of Medicine

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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:

  • Diagnosis of T2DM
  • Currently taking metformin or taking metformin and one additional oral medication for diabetes
  • Body Mass Index (BMI) ≤ 45 kg/m2
  • Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days

Exclusion Criteria:

  • Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
  • Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
  • Current use of injected therapy for treatment of diabetes (insulin or GLP-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): NCT02769481


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

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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT02769481     History of Changes
Other Study ID Numbers: THR-1442-C-480
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 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
Metformin
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors