Trial · NCT02558296

Bexagliflozin Efficacy and Safety Trial

NCT02558296, Phase 3, Completed, Theracos; results first posted 2021-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bexagliflozin Efficacy and Safety Trial. Trials, record NCT02558296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02558296

On this page

Trial

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

Title: Bexagliflozin Efficacy and Safety Trial
NCT number: NCT02558296
Status: Completed
Phases: Phase 3
Enrollment: 1,700 participants, actual
Lead sponsor: Theracos
Conditions: Type 2 Diabetes Mellitus
Interventions: Bexagliflozin, Placebo
First posted: 2015-09-23
Last updated: 2021-07-14
Results first posted: 2021-07-07

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Change in HbA1c From Baseline to Week 24	24 weeks	The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events.
Secondary	Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin	24 weeks	To evaluate the effect of 20 mg bexagliflozin on the change in HbA1c from baseline to week 24 in randomized subjects who have been prescribed insulin to control their diabetes
Secondary	Change in Body Weight From Baseline to Week 48	48 weeks	To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48 in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo
Secondary	Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline	24 weeks	To evaluate the effect of 20 mg bexagliflozin on the change in systolic blood pressure (SBP) from baseline to week 24 in subjects with baseline systolic blood pressure ≥ 140 mmHg compared to placebo
Other	Change in HbA1c From Baseline Over Time	Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168	To assess the effect of 20 mg bexagliflozin treatment on the change in HbA1c from baseline versus placebo over time up to 168 weeks
Other	Change in Fasting Plasma Glucose Over Time	Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168	To evaluate the effect of bexagliflozin treatment on the change in fasting plasma glucose (FPG) versus placebo over time up to 168 weeks
Other	Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification	24 week	To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period
Other	Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification	Duration of study (168 weeks)	To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study period
Other	Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent	24 weeks	To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period
Other	Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent	Duration of study (168 weeks)	To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in HbA1c From Baseline to Week 24	24 weeks	Number of subjects with a value at baseline and at Week 24.	percentage of glycated hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin	24 weeks	Number of subjects with a value at baseline and at week 24.	Percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Change in Body Weight From Baseline to Week 48	48 weeks	Number of subjects with a value at baseline and at Week 48 is included.	kg	LEAST_SQUARES_MEAN
SECONDARY	Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline	24 weeks	Number of subjects with a value at baseline and at week 24	mm Hg	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in HbA1c From Baseline Over Time	Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168	Number of subjects with a value at baseline and at the specified visit.	Percentage of HbA1c	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change in Fasting Plasma Glucose Over Time	Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168	Number of subjects with a value at baseline and at the specified visit.	mmol/L	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification	24 week		Proportion of participants	NUMBER
OTHER_PRE_SPECIFIED	Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification	Duration of study (168 weeks)		Proportion of participants	NUMBER
OTHER_PRE_SPECIFIED	Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent	24 weeks		Proportion of participants	NUMBER
OTHER_PRE_SPECIFIED	Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent	Duration of study (168 weeks)		Proportion of participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group60

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

Outcome	Group	Category	Value	Spread	Units
Change in HbA1c From Baseline to Week 24	Bexagliflozin Tablets, 20 mg		-0.85	95% Confidence Interval -0.90 to -0.80	percentage of glycated hemoglobin
Change in HbA1c From Baseline to Week 24	Placebo Tablets		-0.37	95% Confidence Interval -0.44 to -0.30	percentage of glycated hemoglobin
Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin	Bexagliflozin Tablets, 20 mg		-0.84	95% Confidence Interval -0.92 to -0.77	Percentage of HbA1c
Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin	Placebo Tablets		-0.32	95% Confidence Interval -0.43 to -0.22	Percentage of HbA1c
Change in Body Weight From Baseline to Week 48	Bexagliflozin Tablets, 20 mg		-3.03	95% Confidence Interval -3.27 to -2.80	kg
Change in Body Weight From Baseline to Week 48	Placebo Tablets		-0.38	95% Confidence Interval -0.72 to -0.04	kg
Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline	Bexagliflozin Tablets, 20 mg		-9.83	95% Confidence Interval -11.28 to -8.38	mm Hg
Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline	Placebo Tablets		-6.87	95% Confidence Interval -8.95 to -4.78	mm Hg
Change in HbA1c From Baseline Over Time	Bexagliflozin Tablets, 20 mg	Week 6	-0.69	95% Confidence Interval -0.72 to -0.65	Percentage of HbA1c
Change in HbA1c From Baseline Over Time	Placebo Tablets	Week 6	-0.24	95% Confidence Interval -0.28 to -0.19	Percentage of HbA1c

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Completed the Study Through Week 24	STARTED	Bexagliflozin Tablets, 20 mg	1,133
Completed the Study Through Week 24	STARTED	Placebo Tablets	567
Completed the Study Through Week 24	COMPLETED	Bexagliflozin Tablets, 20 mg	1,089
Completed the Study Through Week 24	COMPLETED	Placebo Tablets	542
Completed the Study Through Week 24	NOT COMPLETED	Bexagliflozin Tablets, 20 mg	44
Completed the Study Through Week 24	NOT COMPLETED	Placebo Tablets	25
Completed the Study	STARTED	Bexagliflozin Tablets, 20 mg	1,133
Completed the Study	STARTED	Placebo Tablets	567
Completed the Study	COMPLETED	Bexagliflozin Tablets, 20 mg	987
Completed the Study	COMPLETED	Placebo Tablets	482

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events746

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	Events
other	Diarrhoea	Gastrointestinal disorders	Bexagliflozin Tablets, 20 mg	72	1,132	90
other	Diarrhoea	Gastrointestinal disorders	Placebo Tablets	31	567	40
other	Nausea	Gastrointestinal disorders	Bexagliflozin Tablets, 20 mg	54	1,132	64
other	Nausea	Gastrointestinal disorders	Placebo Tablets	37	567	45
other	Bronchitis	Infections and infestations	Bexagliflozin Tablets, 20 mg	52	1,132	65
other	Bronchitis	Infections and infestations	Placebo Tablets	34	567	40
other	Nasopharyngitis	Infections and infestations	Bexagliflozin Tablets, 20 mg	96	1,132	115
other	Nasopharyngitis	Infections and infestations	Placebo Tablets	39	567	46
other	Upper respiratory tract infection	Infections and infestations	Bexagliflozin Tablets, 20 mg	112	1,132	147
other	Upper respiratory tract infection	Infections and infestations	Placebo Tablets	53	567	82

1 to 10 of 746Source ClinicalTrials.gov

See all 746 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bexagliflozin Tablets, 20 mg	39	1,132
Total, all-cause mortality	Placebo Tablets	26	567
Total, other adverse events	Bexagliflozin Tablets, 20 mg	739	1,132
Total, other adverse events	Placebo Tablets	386	567
Total, serious adverse events	Bexagliflozin Tablets, 20 mg	373	1,132
Total, serious adverse events	Placebo Tablets	208	567

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 Tablets, 20 mg vs Placebo Tablets: deaths from any cause	Trial comparisons
Bexagliflozin Tablets, 20 mg vs Placebo Tablets: 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/NCT02558296

GET https://conductscience.org/api/trials/v1/NCT02558296/results?page=2

API reference For AI assistants