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 |
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Recruitment Status :
Completed
First Posted : May 11, 2016
Results First Posted : May 27, 2021
Last Update Posted : May 27, 2021
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Sponsor:
Theracos
Information provided by (Responsible Party):
Theracos
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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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 426 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
MedlinePlus Genetics related topics:
Type 2 diabetes
Drug Information
available for:
Glimepiride
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Bexagliflozin
20 mg, tablet
Other Name: EGT0001442 Drug: Placebo for Glimepiride inactive capsules to match active comparator glimepiride |
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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.
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Drug: Placebo for Bexagliflozin
inactive tablet to match active comparator bexagliflozin Drug: Glimepiride 2, 4 or 6 mg, capsule |
Primary Outcome Measures :
- Change From Baseline in HbA1c at Week 60 [ Time Frame: Baseline and Week 60 ]The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).
Secondary Outcome Measures :
- Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2 [ Time Frame: Baseline and 60 weeks ]Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of body weight in subjects with baseline BMI ≥ 25 kg/m2 at week 60 is analyzed using ANCOVA.
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg [ Time Frame: Baseline and 60 weeks ]Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of SBP in subjects with baseline SBP ≥ 140 mmHg at week 60 is analyzed using ANCOVA.
- Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks [ Time Frame: During the 96 week treatment period ]The difference in proportion of subjects with ≥ 1 severe or documented symptomatic hypoglycemia events in the bexagliflozin group compared with glimepiride group over 96 weeks is analyzed using a logistic regression model. The full model included region, baseline HbA1c value, background treatment status (metformin or metformin + OHA), eGFR at baseline ≥ 90 or < 90 mL min 1 per 1.73 m2), treatment as a fixed effect covariate.
- Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60. [ Time Frame: Baseline to Week 60 ]Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% CI is less than 0.
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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
Locations
Show 45 study locations
Sponsors and Collaborators
Theracos
Investigators
| Study Director: | J. Paul Lock, MD | Theracos Sub, LLC |
Study Documents (Full-Text)
Documents provided by Theracos:
Documents provided by Theracos:
Study Protocol [PDF] October 27, 2016
Statistical Analysis Plan [PDF] June 24, 2019
| Responsible Party: | Theracos |
| ClinicalTrials.gov Identifier: | NCT02769481 |
| Other Study ID Numbers: |
THR-1442-C-480 |
| First Posted: | May 11, 2016 Key Record Dates |
| Results First Posted: | May 27, 2021 |
| Last Update Posted: | May 27, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 Glimepiride |
Bexagliflozin Anti-Arrhythmia Agents Hypoglycemic Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors |