Trial · NCT02769481

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

NCT02769481, Phase 3, Completed, Theracos; results first posted 2021-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects. Trials, record NCT02769481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02769481

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
NCT number: NCT02769481
Status: Completed
Phases: Phase 3
Enrollment: 426 participants, actual
Lead sponsor: Theracos
Conditions: Type 2 Diabetes Mellitus
Interventions: Bexagliflozin, Placebo for Bexagliflozin, Glimepiride, Placebo for Glimepiride
First posted: 2016-05-11
Last updated: 2021-05-27
Results first posted: 2021-05-27

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in HbA1c at Week 60	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	Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2	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.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg	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.
Secondary	Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks	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.
Secondary	Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in HbA1c at Week 60	Baseline and Week 60	The intention-to-treat population was used for the analysis. Subjects with a value at baseline and at week 60 were analyzed.	percentage of glycated hemoglin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2	Baseline and 60 weeks	Number of subjects with a value at baseline and at the specified visit	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg	Baseline and 60 weeks		mm Hg	LEAST_SQUARES_MEAN
SECONDARY	Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks	During the 96 week treatment period	Subjects with post-baseline assessment.	Proportion of participants	NUMBER
SECONDARY	Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.	Baseline to Week 60	The intention-to-treat population was used for the analysis. Subjects with a value at baseline and at week 60 were analyzed.	percentage of glycated hemoglobin	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c at Week 60	Bexagliflozin	-0.70	Standard Error 0.058	percentage of glycated hemoglin
Change From Baseline in HbA1c at Week 60	Glimepiride	-0.66	Standard Error 0.058	percentage of glycated hemoglin
Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2	Bexagliflozin	-3.71	Standard Error 0.285	kg
Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2	Glimepiride	0.59	Standard Error 0.284	kg
Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg	Bexagliflozin	-13.48	Standard Error 1.404	mm Hg
Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg	Glimepiride	-6.95	Standard Error 1.460	mm Hg
Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks	Bexagliflozin	0.02	95% Confidence Interval 0.01 to 0.05	Proportion of participants
Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks	Glimepiride	0.15	95% Confidence Interval 0.10 to 0.22	Proportion of participants
Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.	Bexagliflozin	-0.70	Standard Error 0.058	percentage of glycated hemoglobin
Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.	Glimepiride	-0.66	Standard Error 0.058	percentage of glycated hemoglobin

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bexagliflozin	213
Overall Study	STARTED	Glimepiride	213
Overall Study	Study Complete at Week 60	Bexagliflozin	193
Overall Study	Study Complete at Week 60	Glimepiride	192
Overall Study	COMPLETED	Bexagliflozin	180
Overall Study	COMPLETED	Glimepiride	177
Overall Study	NOT COMPLETED	Bexagliflozin	33
Overall Study	NOT COMPLETED	Glimepiride	36

Source ClinicalTrials.gov

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hypoglycemia	Metabolism and nutrition disorders	Bexagliflozin	36	213
other	Hypoglycemia	Metabolism and nutrition disorders	Glimepiride	71	213
other	Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Bexagliflozin	1	213
other	Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Glimepiride	17	213
other	Nasopharyngitis	Infections and infestations	Bexagliflozin	29	213
other	Nasopharyngitis	Infections and infestations	Glimepiride	29	213
other	Urinary Tract Infection	Infections and infestations	Bexagliflozin	25	213
other	Urinary Tract Infection	Infections and infestations	Glimepiride	10	213
other	Bronchitis	Infections and infestations	Bexagliflozin	14	213
other	Bronchitis	Infections and infestations	Glimepiride	16	213

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bexagliflozin	0	213
Total, all-cause mortality	Glimepiride	1	213
Total, other adverse events	Bexagliflozin	98	213
Total, other adverse events	Glimepiride	112	213
Total, serious adverse events	Bexagliflozin	25	213
Total, serious adverse events	Glimepiride	26	213

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Bexagliflozin vs Glimepiride: deaths from any cause	Trial comparisons
Bexagliflozin vs Glimepiride: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02769481

GET https://conductscience.org/api/trials/v1/NCT02769481/events?page=2

API reference For AI assistants