Trial Outcomes & Findings for Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes (NCT NCT02715258)

Last Updated: 2021-06-28

Results Overview

Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

210 participants

Primary outcome timeframe

24 weeks

Results posted on

2021-06-28

Participant Flow

A total of 210 subjects were randomized to be in the bexagliflozin arm or in the placebo arm in a ratio of 2:1.

Participant milestones

Participant milestones
Measure	Bexagliflozin Tablets, 20 mg Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Study STARTED	140	70
Overall Study Intent to Treat/Safety Analysis	138	69
Overall Study COMPLETED	124	64
Overall Study NOT COMPLETED	16	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Bexagliflozin Tablets, 20 mg Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Study Withdrawal by Subject	6	1
Overall Study Lost to Follow-up	7	1
Overall Study Terminated by Sponsor	0	1
Overall Study Death	0	1
Overall Study Subject non-compliant	1	1
Overall Study GCP violation	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bexagliflozin Tablets, 20 mg n=138 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=69 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.	Total n=207 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 10.21 • n=5 Participants	54.7 years STANDARD_DEVIATION 11.02 • n=7 Participants	55.4 years STANDARD_DEVIATION 10.47 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	35 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	34 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=5 Participants	40 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	29 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	6 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	58 Participants n=7 Participants	154 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	21 participants n=5 Participants	12 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment United States	117 participants n=5 Participants	57 participants n=7 Participants	174 participants n=5 Participants
Body Weight at Baseline	90.5 kg STANDARD_DEVIATION 20.48 • n=5 Participants	84.6 kg STANDARD_DEVIATION 19.75 • n=7 Participants	88.6 kg STANDARD_DEVIATION 20.39 • n=5 Participants
Body Mass Index	32.79 kg/m^2 STANDARD_DEVIATION 5.653 • n=5 Participants	30.48 kg/m^2 STANDARD_DEVIATION 4.650 • n=7 Participants	32.01 kg/m^2 STANDARD_DEVIATION 5.437 • n=5 Participants
Systolic Blood Pressure	131.0 mmHg STANDARD_DEVIATION 14.35 • n=5 Participants	125.6 mmHg STANDARD_DEVIATION 13.84 • n=7 Participants	129.2 mmHg STANDARD_DEVIATION 14.38 • n=5 Participants
HbA1c	8.05 percentage of glycated hemoglobin STANDARD_DEVIATION 0.824 • n=5 Participants	7.97 percentage of glycated hemoglobin STANDARD_DEVIATION 0.757 • n=7 Participants	8.02 percentage of glycated hemoglobin STANDARD_DEVIATION 0.801 • n=5 Participants
Fasting Plasma Glucose (FPG)	9.39 mmol/L STANDARD_DEVIATION 1.957 • n=5 Participants	9.45 mmol/L STANDARD_DEVIATION 2.079 • n=7 Participants	9.41 mmol/L STANDARD_DEVIATION 1.994 • n=5 Participants
Duration of Diabetes from Diagnosis to Screening	5.9 years STANDARD_DEVIATION 5.82 • n=5 Participants	6.5 years STANDARD_DEVIATION 5.21 • n=7 Participants	6.1 years STANDARD_DEVIATION 5.62 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Intention-to-Treat Population

Outcome measures

Outcome measures
Measure	Bexagliflozin Tablets, 20 mg n=138 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=69 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Change in HbA1c From Baseline at Week 24	-0.51 % of HbA1c Standard Error 0.082	-0.10 % of HbA1c Standard Error 0.108

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT analysis set

Blood pressure (BP) measurements are obtained using a calibrated sphygmomanometer in sitting, supine and standing positions. The left arm and same cuff sizes should be used for each measurement at all visits. If the left arm cannot be used at the screening visit or during the study for BP measurements, the reason should be documented and the right arm should be used for BP measurements for all subsequent visits.

Outcome measures

Outcome measures
Measure	Bexagliflozin Tablets, 20 mg n=138 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=69 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Change in Systolic Blood Pressure (SBP) From Baseline at Week 24	-0.60 mmHg Standard Error 1.145	1.54 mmHg Standard Error 1.524

SECONDARY outcome

Timeframe: 24 weeks

Population: Subjects with BMI \>= 25 kg/m2 in the ITT analysis set

The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination.

Outcome measures

Outcome measures
Measure	Bexagliflozin Tablets, 20 mg n=128 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=62 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2	-1.85 Kg Standard Error 0.394	-1.06 Kg Standard Error 0.485

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: Subjects with a value at baseline and Week 6, 12, 18 and 24

The fasting plasma glucose (FPG) is measured at each study visit. The subject must have fasted for approximately 10 hours prior to the blood draw to ensure that the FPG value is truly a fasting sample.

Outcome measures

Outcome measures
Measure	Bexagliflozin Tablets, 20 mg n=133 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=65 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time Change from baseline at Week 6	-1.40 mmol/L Standard Deviation 2.116	0.50 mmol/L Standard Deviation 2.655
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time Change from baseline at Week 12	-1.41 mmol/L Standard Deviation 1.904	0.33 mmol/L Standard Deviation 2.103
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time Change from baseline at Week 18	-1.17 mmol/L Standard Deviation 2.058	0.03 mmol/L Standard Deviation 2.337
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time Change from baseline at Week 24	-1.02 mmol/L Standard Deviation 2.013	-0.15 mmol/L Standard Deviation 2.480

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: Subjects with a value at baseline and at Week 6, 12, 18 and 24

Outcome measures

Outcome measures
Measure	Bexagliflozin Tablets, 20 mg n=133 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=65 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Change From Baseline of HbA1c From Baseline Over Time Change from baseline at Week 6	-0.47 % of HbA1c Standard Error 0.064	0.13 % of HbA1c Standard Error 0.082
Change From Baseline of HbA1c From Baseline Over Time Change from baseline at Week 12	-0.61 % of HbA1c Standard Error 0.072	0.10 % of HbA1c Standard Error 0.095
Change From Baseline of HbA1c From Baseline Over Time Change from baseline at Week 18	-0.58 % of HbA1c Standard Error 0.071	-0.01 % of HbA1c Standard Error 0.093
Change From Baseline of HbA1c From Baseline Over Time Change from baseline at Week 24	-0.51 % of HbA1c Standard Error 0.082	-0.10 % of HbA1c Standard Error 0.108

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 24 weeks

Population: Subjects with a value at baseline and at Week 6, 12, 18 and 24

Outcome measures

Outcome measures
Measure	Bexagliflozin Tablets, 20 mg n=133 Participants Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=65 Participants Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Proportion of Subjects Who Achieve an HbA1c < 7% Proportion of subjects with HbA1c < 7% at Week 6	35 participants	6 participants
Proportion of Subjects Who Achieve an HbA1c < 7% Proportion of subjects with HbA1c < 7% at Week 12	44 participants	8 participants
Proportion of Subjects Who Achieve an HbA1c < 7% Proportion of subjects with HbA1c < 7% at Week 18	42 participants	10 participants
Proportion of Subjects Who Achieve an HbA1c < 7% Proportion of subjects with HbA1c < 7% at Week 24	41 participants	13 participants

Adverse Events

Bexagliflozin Tablets, 20 mg

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo Tablets

Serious events: 1 serious events

Other events: 25 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Bexagliflozin Tablets, 20 mg n=138 participants at risk Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=69 participants at risk Each subject was to take placebo (inactive tablet) once daily for 24 weeks.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.72% 1/138 • Number of events 1 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	0.00% 0/69 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Cardiac disorders Cardiomyopathy	0.00% 0/138 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	1.4% 1/69 • Number of events 1 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.

Other adverse events

Other adverse events
Measure	Bexagliflozin Tablets, 20 mg n=138 participants at risk Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks.	Placebo Tablets n=69 participants at risk Each subject was to take placebo (inactive tablet) once daily for 24 weeks.
Infections and infestations Urinary tract infection	5.1% 7/138 • Number of events 7 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	2.9% 2/69 • Number of events 2 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Infections and infestations Upper respiratory tract infection	3.6% 5/138 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	4.3% 3/69 • Number of events 3 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Gastrointestinal disorders Abdominal pain	3.6% 5/138 • Number of events 6 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	7.2% 5/69 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Gastrointestinal disorders Diarrhea	3.6% 5/138 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	7.2% 5/69 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Gastrointestinal disorders Nausea	3.6% 5/138 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	2.9% 2/69 • Number of events 2 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Renal and urinary disorders Polyuria	7.2% 10/138 • Number of events 10 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	2.9% 2/69 • Number of events 2 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Metabolism and nutrition disorders Hyperglycemia	2.2% 3/138 • Number of events 3 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	4.3% 3/69 • Number of events 3 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Nervous system disorders Headache	2.9% 4/138 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	7.2% 5/69 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
General disorders Fatigue	3.6% 5/138 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	0.00% 0/69 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.
Vascular disorders Hypertension	2.2% 3/138 • Number of events 4 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.	7.2% 5/69 • Number of events 5 • Adverse event data were collected from -8 weeks (V2) to 26 weeks (V12) according to the Schedule of Events outlined in the study protocol. Subjects in the Bexagliflozin group had mean study drug exposure of 22.52 weeks and the placebo group had mean mean study drug exposure of 22.90 weeks.

Additional Information

Albert Collinson

Theracos Sub, LLC

Phone: (508) 630-2129

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Investigator does not have the right to publish the results.
Publication restrictions are in place

Restriction type: OTHER