The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment

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: NCT02836873
Recruitment Status : Completed
First Posted : July 19, 2016
Results First Posted : April 27, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Theracos

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Bexagliflozin
Drug: Placebo
Enrollment 312
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
Period Title: Overall Study
Started 157 155
Completed 152 144
Not Completed 5 11
Reason Not Completed
Protocol Violation             0             1
Adverse Event             1             4
Withdrawal by Subject             2             2
Lost to Follow-up             1             3
Physician Decision             0             1
Other             1             0
Arm/Group Title Bexagliflozin 20 mg Placebo Total
Hide Arm/Group Description Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Each subject will receive a placebo (inactive) tablet once daily for the duration of the study. Total of all reporting groups
Overall Number of Baseline Participants 157 155 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 155 participants 312 participants
69.3  (8.36) 69.9  (8.29) 69.6  (8.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
Female
65
  41.4%
51
  32.9%
116
  37.2%
Male
92
  58.6%
104
  67.1%
196
  62.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
Hispanic or Latino
7
   4.5%
17
  11.0%
24
   7.7%
Not Hispanic or Latino
149
  94.9%
138
  89.0%
287
  92.0%
Unknown or Not Reported
1
   0.6%
0
   0.0%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
61
  38.9%
59
  38.1%
120
  38.5%
Native Hawaiian or Other Pacific Islander
2
   1.3%
0
   0.0%
2
   0.6%
Black or African American
9
   5.7%
6
   3.9%
15
   4.8%
White
83
  52.9%
88
  56.8%
171
  54.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.3%
2
   1.3%
4
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 157 participants 155 participants 312 participants
United States 53 50 103
Japan 58 58 116
France 12 16 28
Spain 34 31 65
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 157 participants 155 participants 312 participants
164.8  (9.94) 164.7  (10.58) 164.8  (10.25)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 157 participants 155 participants 312 participants
82.90  (20.509) 82.59  (21.196) 82.75  (20.820)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 157 participants 155 participants 312 participants
30.29  (5.988) 30.10  (5.774) 30.20  (5.874)
SBP Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 157 participants 155 participants 312 participants
< 130 mm Hg
50
  31.8%
42
  27.1%
92
  29.5%
> 130 mm Hg
107
  68.2%
113
  72.9%
220
  70.5%
eGFR in Sub-group  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m^2
 Number Analyzed 157 participants 155 participants 312 participants
Stage 3a CKD: eGFR High Group 51.76  (5.307) 51.27  (4.404) 51.52  (4.884)
Stage 3b CKD: eGFR Low Group 37.79  (4.572) 37.87  (4.629) 37.83  (4.586)
Subjects in eGFR Sub-group at Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 157 participants 155 participants 312 participants
Stage 3a CKD: eGFR High Group
86
  54.8%
80
  51.6%
166
  53.2%
Stage 3b CKD: eGFR Low Group
71
  45.2%
75
  48.4%
146
  46.8%
1.Primary Outcome
Title Change From Baseline in HbA1c at 24 Weeks
Hide Description 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 moderate renal impairment.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description:
Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
Overall Number of Participants Analyzed 157 155
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycated hemoglobin
-0.59  (0.065) -0.31  (0.066)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin 20 mg, Placebo
Comments This is a mixed-effects repeated measures analysis including region, screening anti-diabetic treatment regimen, baseline eGFR, treatment, visit, treatment-by-visit interaction and baseline HbA1c as a fixed effect covariate. Data from Weeks 6, 12, and 24 are used in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Mixed-effects repeated measures
Comments Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.46 to -0.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Body Weight From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2
Hide Description A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change in BMI from baseline to week 24 in subjects with a BMI ≥ 25 kg/m2.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only number of subjects with a value at baseline and at the specific visit is included.
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description:
Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
Overall Number of Participants Analyzed 122 117
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.31  (0.265) -0.55  (0.269)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin 20 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed-effects repeated measures
Comments Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -1.76
Confidence Interval (2-Sided) 95%
-2.50 to -1.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) in Subjects With Baseline SBP ≥ 130 mm Hg at Week 24
Hide Description A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change from baseline in SBP to in subjects with baseline SBP ≥ 130 mm Hg at Week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only number of subjects with a value at baseline and at Week 24 is included.
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description:
Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
Overall Number of Participants Analyzed 104 108
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-10.14  (1.477) -7.51  (1.460)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin 20 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2035
Comments [Not Specified]
Method Mixed-effects repeated measures
Comments Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -2.63
Confidence Interval (2-Sided) 95%
-6.70 to 1.44
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in HbA1c in Subjects With Stage 3a CKD (eGFR 45 to 59 mL/Min/1.73 m2) at Week 24
Hide Description A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change in HbA1c from baseline in subjects with stage 3a CKD (eGFR 45 to 59 mL/min/1.73 m2) at week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had the eGFR between 45 and 59 mL/min/1.73 m2 are included in this analysis.
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description:
Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
Overall Number of Participants Analyzed 86 80
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycated hemoglobin
-0.63  (0.086) -0.44  (0.089)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin 20 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1156
Comments [Not Specified]
Method Mixed-effects repeated measures
Comments Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.44 to 0.05
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in HbA1c in Subjects With Stage 3b CKD (eGFR 30 to 44 mL/Min/1.73 m2) at Week 24
Hide Description A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change in HbA1c from baseline in subjects with stage 3b CKD (eGFR 30 to 44 mL/min/1.73 m2) at week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with eGFR between 30 and 44 mL/min/1.73 m2 were included in this anlaysis.
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description:
Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
Overall Number of Participants Analyzed 71 75
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycated hemoglobin
-0.57  (0.100) -0.20  (0.097)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bexagliflozin 20 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Mixed-effects repeated measures
Comments Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.65 to -0.10
Estimation Comments [Not Specified]
Time Frame Adverse event data was collected from Week -1 (Visit 2) to Week 26 (Visit 29).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bexagliflozin 20 mg Placebo
Hide Arm/Group Description Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
All-Cause Mortality
Bexagliflozin 20 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/157 (0.00%)      0/155 (0.00%)    
Hide Serious Adverse Events
Bexagliflozin 20 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/157 (7.01%)      9/155 (5.81%)    
Cardiac disorders     
Bundle branch block left † 1  1/157 (0.64%)  0/155 (0.00%) 
Cardiogenic shock † 1  0/157 (0.00%)  1/155 (0.65%) 
Coronary artery disease † 1  0/157 (0.00%)  1/155 (0.65%) 
Myocardial infarction † 1  1/157 (0.64%)  0/155 (0.00%) 
Ear and labyrinth disorders     
Deafness unilateral † 1  1/157 (0.64%)  0/155 (0.00%) 
Gastrointestinal disorders     
Gastritis erosive † 1  1/157 (0.64%)  0/155 (0.00%) 
Intestinal ischemia † 1  0/157 (0.00%)  1/155 (0.65%) 
Esophagitis † 1  1/157 (0.64%)  0/155 (0.00%) 
Pancreatitis acute † 1  0/157 (0.00%)  1/155 (0.65%) 
Hepatobiliary disorders     
Cholecystitis acute † 1  0/157 (0.00%)  1/155 (0.65%) 
Infections and infestations     
Gastroenteritis † 1  0/157 (0.00%)  1/155 (0.65%) 
Lower respiratory tract infection † 1  0/157 (0.00%)  1/155 (0.65%) 
Sepsis † 1  1/157 (0.64%)  0/155 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycemia † 1  1/157 (0.64%)  0/155 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/157 (0.64%)  0/155 (0.00%) 
Lumbar spinal stenosis † 1  1/157 (0.64%)  0/155 (0.00%) 
Neuropathic anthropathy † 1  0/157 (0.00%)  1/155 (0.65%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma colon † 1  1/157 (0.64%)  0/155 (0.00%) 
Colon cancer † 1  0/157 (0.00%)  1/155 (0.65%) 
Gastric cancer † 1  0/157 (0.00%)  1/155 (0.65%) 
Rectal adenocarcinoma † 1  0/157 (0.00%)  1/155 (0.65%) 
Nervous system disorders     
Carotid artery disease † 1  1/157 (0.64%)  0/155 (0.00%) 
Cerebral infarction † 1  1/157 (0.64%)  0/155 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea exertional † 1  1/157 (0.64%)  0/155 (0.00%) 
Respiratory distress † 1  0/157 (0.00%)  1/155 (0.65%) 
Vascular disorders     
Orthostatic hypotension † 1  0/157 (0.00%)  1/155 (0.65%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bexagliflozin 20 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/157 (35.67%)      42/155 (27.10%)    
Gastrointestinal disorders     
Nausea † 1  8/157 (5.10%)  9 11/155 (7.10%)  12
Infections and infestations     
Nasopharyngitis † 1  11/157 (7.01%)  13 13/155 (8.39%)  21
Urinary tract infection † 1  10/157 (6.37%)  12 5/155 (3.23%)  5
Bronchitis † 1  8/157 (5.10%)  8 2/155 (1.29%)  2
Metabolism and nutrition disorders     
Hypoglycaemia † 1  40/157 (25.48%)  258 40/155 (25.81%)  261
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  9/157 (5.73%)  11 5/155 (3.23%)  5
Renal and urinary disorders     
Polyuria † 1  12/157 (7.64%)  15 7/155 (4.52%)  7
Acute kidney injury † 1  8/157 (5.10%)  9 6/155 (3.87%)  6
1
Term from vocabulary, MedDRA 19.0
†
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 PI has no right to publish the trial 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
Layout table for additonal information
Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT02836873    
Other Study ID Numbers: THR-1442-C-448
First Submitted: July 14, 2016
First Posted: July 19, 2016
Results First Submitted: March 30, 2021
Results First Posted: April 27, 2021
Last Update Posted: June 30, 2021