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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715258
Recruitment Status : Completed
First Posted : March 22, 2016
Results First Posted : April 28, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Theracos

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Bexagliflozin
Drug: Placebo
Enrollment 210
Recruitment Details  
Pre-assignment Details A total of 210 subjects were randomized to be in the bexagliflozin arm or in the placebo arm in a ratio of 2:1.
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks. Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Period Title: Overall Study
Started 140 70
Intent to Treat/Safety Analysis [1] 138 69
Completed 124 64
Not Completed 16 6
Reason Not Completed
Withdrawal by Subject             6             1
Lost to Follow-up             7             1
Terminated by Sponsor             0             1
Death             0             1
Subject non-compliant             1             1
GCP violation             2             1
[1]
Three randomized subject numbers were excluded in the ITT and the safety populations due to GCP violation.
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets Total
Hide Arm/Group Description Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks. Each subject will receive placebo (inactive tablet) once daily for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 138 69 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 69 participants 207 participants
55.8  (10.21) 54.7  (11.02) 55.4  (10.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 69 participants 207 participants
Female
72
  52.2%
35
  50.7%
107
  51.7%
Male
66
  47.8%
34
  49.3%
100
  48.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 69 participants 207 participants
Hispanic or Latino
67
  48.6%
40
  58.0%
107
  51.7%
Not Hispanic or Latino
71
  51.4%
29
  42.0%
100
  48.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 69 participants 207 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
15
  10.9%
5
   7.2%
20
   9.7%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.5%
Black or African American
25
  18.1%
6
   8.7%
31
  15.0%
White
96
  69.6%
58
  84.1%
154
  74.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.7%
0
   0.0%
1
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 138 participants 69 participants 207 participants
Canada 21 12 33
United States 117 57 174
Body Weight at Baseline  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 138 participants 69 participants 207 participants
90.5  (20.48) 84.6  (19.75) 88.6  (20.39)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 138 participants 69 participants 207 participants
32.79  (5.653) 30.48  (4.650) 32.01  (5.437)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 138 participants 69 participants 207 participants
131.0  (14.35) 125.6  (13.84) 129.2  (14.38)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycated hemoglobin
Number Analyzed 138 participants 69 participants 207 participants
8.05  (0.824) 7.97  (0.757) 8.02  (0.801)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 138 participants 69 participants 207 participants
9.39  (1.957) 9.45  (2.079) 9.41  (1.994)
Duration of Diabetes from Diagnosis to Screening  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 69 participants 207 participants
5.9  (5.82) 6.5  (5.21) 6.1  (5.62)
1.Primary Outcome
Title Change in HbA1c From Baseline at Week 24
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat Population
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description:
Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Number of Participants Analyzed 138 69
Least Squares Mean (Standard Error)
Unit of Measure: % of HbA1c
-0.51  (0.082) -0.10  (0.108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Analysis of change from baseline in HbA1c (%) at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.66 to -0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.68 to -0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.80 to -0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.64 to -0.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP) From Baseline at Week 24
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description:
Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Number of Participants Analyzed 138 69
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.60  (1.145) 1.54  (1.524)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Analysis of change from baseline in SBP (mm Hg) at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2340
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -2.14
Confidence Interval (2-Sided) 95%
-5.66 to 1.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2937
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -1.91
Confidence Interval (2-Sided) 95%
-5.48 to 1.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4030
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -1.72
Confidence Interval (2-Sided) 95%
-5.75 to 2.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2160
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -2.09
Confidence Interval (2-Sided) 95%
-5.41 to 1.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2
Hide Description The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with BMI >= 25 kg/m2 in the ITT analysis set
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description:
Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Number of Participants Analyzed 128 62
Least Squares Mean (Standard Error)
Unit of Measure: Kg
-1.85  (0.394) -1.06  (0.485)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1222
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-1.80 to 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2014
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-1.65 to 0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0638
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.88 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1456
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-1.63 to 0.24
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a value at baseline and Week 6, 12, 18 and 24
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description:
Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Number of Participants Analyzed 133 65
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change from baseline at Week 6 Number Analyzed 133 participants 65 participants
-1.40  (2.116) 0.50  (2.655)
Change from baseline at Week 12 Number Analyzed 132 participants 64 participants
-1.41  (1.904) 0.33  (2.103)
Change from baseline at Week 18 Number Analyzed 127 participants 63 participants
-1.17  (2.058) 0.03  (2.337)
Change from baseline at Week 24 Number Analyzed 125 participants 64 participants
-1.02  (2.013) -0.15  (2.480)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -1.50
Confidence Interval (2-Sided) 95%
-1.92 to -1.09
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Change From Baseline of HbA1c From Baseline Over Time
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a value at baseline and at Week 6, 12, 18 and 24
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description:
Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Number of Participants Analyzed 133 65
Least Squares Mean (Standard Error)
Unit of Measure: % of HbA1c
Change from baseline at Week 6 Number Analyzed 133 participants 65 participants
-0.47  (0.064) 0.13  (0.082)
Change from baseline at Week 12 Number Analyzed 131 participants 64 participants
-0.61  (0.072) 0.10  (0.095)
Change from baseline at Week 18 Number Analyzed 127 participants 63 participants
-0.58  (0.071) -0.01  (0.093)
Change from baseline at Week 24 Number Analyzed 133 participants 65 participants
-0.51  (0.082) -0.10  (0.108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Change from baseline in HbA1c (%) at Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.79 to -0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Change from baseline in HbA1c (%) at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-0.92 to -0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Change from baseline in HbA1c (%) at Week 18
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.78 to -0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Change from baseline in HbA1c (%) at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.66 to -0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Change from baseline in HbA1c (%) across 24 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter mixed-effects repeated measures
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-0.76 to -0.39
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Proportion of Subjects Who Achieve an HbA1c < 7%
Hide Description 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.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a value at baseline and at Week 6, 12, 18 and 24
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description:
Each subject will receive bexagliflozin tablets, 20 mg once daily for 24 weeks.
Each subject will receive placebo (inactive tablet) once daily for 24 weeks.
Overall Number of Participants Analyzed 133 65
Measure Type: Number
Unit of Measure: participants
Proportion of subjects with HbA1c < 7% at Week 6 Number Analyzed 133 participants 65 participants
35 6
Proportion of subjects with HbA1c < 7% at Week 12 Number Analyzed 131 participants 64 participants
44 8
Proportion of subjects with HbA1c < 7% at Week 18 Number Analyzed 127 participants 63 participants
42 10
Proportion of subjects with HbA1c < 7% at Week 24 Number Analyzed 124 participants 64 participants
41 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin Tablets, 20 mg, Placebo Tablets
Comments Model-Adjusted proportion of subjects with HbA1c <7% across 24 weeks
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.39
Confidence Interval (2-Sided) 95%
1.69 to 6.80
Estimation Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bexagliflozin Tablets, 20 mg Placebo Tablets
Hide Arm/Group Description Each subject was to take bexagliflozin tablets, 20 mg once daily for 24 weeks. Each subject was to take placebo (inactive tablet) once daily for 24 weeks.
All-Cause Mortality
Bexagliflozin Tablets, 20 mg Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/138 (0.00%)      1/69 (1.45%)    
Hide Serious Adverse Events
Bexagliflozin Tablets, 20 mg Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/138 (0.72%)      1/69 (1.45%)    
Cardiac disorders     
Cardiomyopathy †  0/138 (0.00%)  0 1/69 (1.45%)  1
Musculoskeletal and connective tissue disorders     
Tenosynovitis †  1/138 (0.72%)  1 0/69 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Bexagliflozin Tablets, 20 mg Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/138 (29.71%)      25/69 (36.23%)    
Gastrointestinal disorders     
Abdominal pain †  5/138 (3.62%)  6 5/69 (7.25%)  5
Diarrhea †  5/138 (3.62%)  5 5/69 (7.25%)  5
Nausea †  5/138 (3.62%)  5 2/69 (2.90%)  2
General disorders     
Fatigue †  5/138 (3.62%)  5 0/69 (0.00%)  0
Infections and infestations     
Urinary tract infection †  7/138 (5.07%)  7 2/69 (2.90%)  2
Upper respiratory tract infection †  5/138 (3.62%)  5 3/69 (4.35%)  3
Metabolism and nutrition disorders     
Hyperglycemia †  3/138 (2.17%)  3 3/69 (4.35%)  3
Nervous system disorders     
Headache †  4/138 (2.90%)  5 5/69 (7.25%)  5
Renal and urinary disorders     
Polyuria †  10/138 (7.25%)  10 2/69 (2.90%)  2
Vascular disorders     
Hypertension †  3/138 (2.17%)  4 5/69 (7.25%)  5
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator does not have the right to publish the results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Albert Collinson
Organization: Theracos Sub, LLC
Phone: (508) 630-2129
EMail: acollinson@theracos.com
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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT02715258    
Other Study ID Numbers: THR-1442-C-450
First Submitted: March 11, 2016
First Posted: March 22, 2016
Results First Submitted: April 1, 2021
Results First Posted: April 28, 2021
Last Update Posted: June 28, 2021