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Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

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: NCT02926937
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Sotagliflozin (SAR439954)
Drug: Placebo
Enrollment 399
Recruitment Details Participants took part in the study at 70 investigative sites in the United States, Canada, Mexico, from 11 November 2016 to 17 May 2019.
Pre-assignment Details Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups: Placebo, Sotagliflozin 400 milligrams (mg) or Sotagliflozin 200 mg.
Arm/Group Title Placebo Sotagliflozin 400 mg Sotagliflozin 200 mg
Hide Arm/Group Description Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks. Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Period Title: Overall Study
Started 150 142 107
Completed 131 127 96
Not Completed 19 15 11
Reason Not Completed
Adverse Event             0             1             1
Poor Compliance to Protocol             1             0             0
Lost to Follow-up             4             5             0
At the Participant's own Request             11             5             8
Reason not Specified             3             4             2
Arm/Group Title Placebo Sotagliflozin 400 mg Sotagliflozin 200 mg Total
Hide Arm/Group Description Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 150 142 107 399
Hide Baseline Analysis Population Description
The randomized population included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 142 participants 107 participants 399 participants
55.3  (11.2) 54.7  (11.2) 52.3  (11.4) 54.3  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 142 participants 107 participants 399 participants
Female
72
  48.0%
68
  47.9%
53
  49.5%
193
  48.4%
Male
78
  52.0%
74
  52.1%
54
  50.5%
206
  51.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 142 participants 107 participants 399 participants
Hispanic or Latino
99
  66.0%
85
  59.9%
69
  64.5%
253
  63.4%
Not Hispanic or Latino
51
  34.0%
57
  40.1%
36
  33.6%
144
  36.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   1.9%
2
   0.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 142 participants 107 participants 399 participants
American Indian or Alaska Native
12
   8.0%
3
   2.1%
3
   2.8%
18
   4.5%
Asian
9
   6.0%
4
   2.8%
11
  10.3%
24
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  11.3%
18
  12.7%
12
  11.2%
47
  11.8%
White
112
  74.7%
117
  82.4%
77
  72.0%
306
  76.7%
More than one race
0
   0.0%
0
   0.0%
2
   1.9%
2
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   1.9%
2
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 150 participants 142 participants 107 participants 399 participants
Canada 11 13 7 31
United States 96 100 63 259
Mexico 43 29 37 109
Hemoglobin A1c (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 150 participants 142 participants 107 participants 399 participants
8.11  (0.88) 8.14  (0.92) 8.00  (0.81) 8.09  (0.87)
Systolic Blood Pressure (SBP)  
Mean (Standard Deviation)
Unit of measure:  Millimeter of mercury (mmHg)
Number Analyzed 150 participants 142 participants 107 participants 399 participants
127.27  (13.08) 128.70  (4.80) 128.08  (13.08) 128.00  (13.70)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Hide Description An analysis of covariance (ANCOVA) model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-to-treat (ITT) population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-0.34  (0.120) -1.03  (0.122)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares (LS) Mean
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.975 to -0.415
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Least Squares Mean (Standard Error)
Unit of Measure: millimole per liter (mmol/L)
-0.591  (0.1943) -1.156  (0.1964)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.565
Confidence Interval (2-Sided) 95%
-1.0166 to -0.1140
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 200 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks
Overall Number of Participants Analyzed 110 107
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.500  (0.2443) -0.847  (0.2477)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 200 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups under Amendment 1 randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2081
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.346
Confidence Interval (2-Sided) 95%
-0.8853 to 0.1928
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1.Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.201  (0.2739) -1.756  (0.2719)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥ 130mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.556
Confidence Interval (2-Sided) 95%
-2.1876 to -0.9234
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1 with Baseline SBP ≥130 mmHg. Missing data are imputed using washout imputation method under the missing not at random framework. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 55 48
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.45  (2.419) -7.96  (2.282)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments The change from baseline to Week 12 is analyzed using analysis ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening and country as fixed effects, and baseline SBP as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1680
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -3.50
Confidence Interval (2-Sided) 95%
-8.478 to 1.476
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.57  (1.088) -1.35  (1.116)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5467
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-3.311 to 1.753
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 200 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 110 107
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.62  (1.215) -4.82  (1.211)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 200 mg
Comments The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0193
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -3.19
Confidence Interval (2-Sided) 95%
-5.869 to -0.518
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Least Squares Mean (Standard Error)
Unit of Measure: kilogram (Kg)
-0.79  (0.373) -2.33  (0.379)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-2.404 to -0.676
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 200 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 110 107
Least Squares Mean (Standard Error)
Unit of Measure: kg
-0.52  (0.509) -1.69  (0.518)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 200 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0406
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.17
Confidence Interval (2-Sided) 95%
-2.281 to -0.050
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Hide Description [Not Specified]
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Measure Type: Number
Unit of Measure: percentage of participants
10.7 23.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (<=8.0, >8.0%) at screening, randomization strata of mean SBP (<130, >=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
4.18 to 21.02
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Hide Description [Not Specified]
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Measure Type: Number
Unit of Measure: percentage of participants
28.0 47.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 400 mg
Comments Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (<=8.0, >8.0%) at screening, randomization strata of mean SBP (<130, >=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 19.2
Confidence Interval (2-Sided) 95%
8.39 to 30.00
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo)
Hide Description An ANCOVA model was used for the analysis.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework.
Arm/Group Title Placebo Sotagliflozin 200 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 110 107
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-0.26  (0.143) -0.93  (0.148)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sotagliflozin 200 mg
Comments The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-0.989 to -0.354
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo)
Hide Description Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL]. Participants may be reported in more than one category.
Time Frame Week 26
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Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1.
Arm/Group Title Placebo Sotagliflozin 400 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 150 142
Measure Type: Number
Unit of Measure: percentage of participants
Any hypoglycemia 2.7 2.1
Documented symptomatic hypoglycemia 1.3 0.7
Severe or documented symptomatic hypoglycemia 1.3 0.7
14.Other Pre-specified Outcome
Title Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo)
Hide Description Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL]. Participants may be reported in more than one category.
Time Frame Week 26
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Hide Analysis Population Description
Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1.
Arm/Group Title Placebo Sotagliflozin 200 mg
Hide Arm/Group Description:
Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Unit of Measure: percentage of participants
Any hypoglycemia 2.7 1.9
Documented symptomatic hypoglycemia 0.9 0.9
Severe or documented symptomatic hypoglycemia 0.9 0.9
Time Frame First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Adverse Event Reporting Description Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
 
Arm/Group Title Placebo Sotagliflozin 400 mg Sotagliflozin 200 mg
Hide Arm/Group Description Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
All-Cause Mortality
Placebo Sotagliflozin 400 mg Sotagliflozin 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/142 (0.00%)   0/107 (0.00%) 
Hide Serious Adverse Events
Placebo Sotagliflozin 400 mg Sotagliflozin 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/150 (2.00%)   3/142 (2.11%)   2/107 (1.87%) 
Eye disorders       
Retinal detachment  1  0/150 (0.00%)  1/142 (0.70%)  0/107 (0.00%) 
Gastrointestinal disorders       
Colitis  1  1/150 (0.67%)  0/142 (0.00%)  0/107 (0.00%) 
Gastrooesophageal reflux disease  1  1/150 (0.67%)  0/142 (0.00%)  0/107 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/150 (0.67%)  0/142 (0.00%)  0/107 (0.00%) 
Injury, poisoning and procedural complications       
Multiple fractures  1  0/150 (0.00%)  0/142 (0.00%)  1/107 (0.93%) 
Road traffic accident  1  0/150 (0.00%)  0/142 (0.00%)  1/107 (0.93%) 
Traumatic haemothorax  1  0/150 (0.00%)  0/142 (0.00%)  1/107 (0.93%) 
Traumatic lung injury  1  0/150 (0.00%)  0/142 (0.00%)  1/107 (0.93%) 
Psychiatric disorders       
Depression  1  1/150 (0.67%)  0/142 (0.00%)  0/107 (0.00%) 
Suicide attempt  1  1/150 (0.67%)  0/142 (0.00%)  0/107 (0.00%) 
Renal and urinary disorders       
Chronic kidney disease  1  0/150 (0.00%)  1/142 (0.70%)  1/107 (0.93%) 
Vascular disorders       
Peripheral artery thrombosis  1  0/150 (0.00%)  1/142 (0.70%)  0/107 (0.00%) 
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sotagliflozin 400 mg Sotagliflozin 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/150 (13.33%)   17/142 (11.97%)   14/107 (13.08%) 
Gastrointestinal disorders       
Diarrhoea  1  5/150 (3.33%)  9/142 (6.34%)  5/107 (4.67%) 
Infections and infestations       
Urinary tract infection  1  7/150 (4.67%)  8/142 (5.63%)  3/107 (2.80%) 
Nervous system disorders       
Headache  1  9/150 (6.00%)  4/142 (2.82%)  7/107 (6.54%) 
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
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.
Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs
Organization: Lexicon Pharmaceuticals, Inc,
Phone: 338-6064 ext (510)
EMail: medical-information@lexpharma.com
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02926937    
Other Study ID Numbers: EFC14833
2016-001799-31 ( EudraCT Number )
U1111-1180-6169 ( Other Identifier: UTN )
First Submitted: October 5, 2016
First Posted: October 6, 2016
Results First Submitted: April 16, 2021
Results First Posted: June 21, 2021
Last Update Posted: June 21, 2021