Trial Outcomes & Findings for Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (NCT NCT03386344)
NCT ID: NCT03386344
Last Updated: 2021-06-25
Results Overview
An analysis of covariance (ANCOVA) model is used for analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
376 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2021-06-25
Participant Flow
Participants took part in the study at 53 investigative sites in the United States, Australia, Canada, Korea, Republic of Mexico, New Zealand, Russian Federation, and Taiwan from 19 February 2018 to 30 May 2020.
Participants with a diagnosis of Type 2 Diabetes Mellitus (DM), were enrolled in 1 of 3 treatment groups: Placebo, Sotagliflozin 200 milligrams (mg) or Sotagliflozin 400 mg.
Participant milestones
| Measure |
Placebo
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
126
|
125
|
125
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
117
|
116
|
116
|
Reasons for withdrawal
| Measure |
Placebo
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
1
|
|
Overall Study
Poor Compliance to Protocol
|
0
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
101
|
102
|
106
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
|
Overall Study
At the Participant's own Request
|
7
|
7
|
8
|
|
Overall Study
Reason not Specified
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Baseline characteristics by cohort
| Measure |
Placebo
n=126 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
66.1 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
66.5 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
66.3 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
167 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
209 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
308 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
263 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=99 Participants
|
8 participants
n=107 Participants
|
3 participants
n=206 Participants
|
13 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=99 Participants
|
17 participants
n=107 Participants
|
20 participants
n=206 Participants
|
57 participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
7 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Region of Enrollment
Mexico
|
16 participants
n=99 Participants
|
14 participants
n=107 Participants
|
17 participants
n=206 Participants
|
47 participants
n=7 Participants
|
|
Region of Enrollment
New Zealand
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
11 participants
n=206 Participants
|
29 participants
n=7 Participants
|
|
Region of Enrollment
Russia
|
17 participants
n=99 Participants
|
14 participants
n=107 Participants
|
19 participants
n=206 Participants
|
50 participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
7 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
45 participants
n=107 Participants
|
41 participants
n=206 Participants
|
128 participants
n=7 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.38 percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=99 Participants
|
8.32 percentage of HbA1c
STANDARD_DEVIATION 0.96 • n=107 Participants
|
8.32 percentage of HbA1c
STANDARD_DEVIATION 0.95 • n=206 Participants
|
8.34 percentage of HbA1c
STANDARD_DEVIATION 0.94 • n=7 Participants
|
|
Systolic Blood Pressure (SBP)
|
133.04 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.10 • n=99 Participants
|
131.48 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.69 • n=107 Participants
|
134.65 millimeter of mercury (mmHg)
STANDARD_DEVIATION 14.74 • n=206 Participants
|
133.06 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.88 • n=7 Participants
|
|
Bone Mineral Density (BMD) T-score: Lumbar Spine
|
0.69 t-score
STANDARD_DEVIATION 2.0 • n=99 Participants
|
0.70 t-score
STANDARD_DEVIATION 1.74 • n=107 Participants
|
0.88 t-score
STANDARD_DEVIATION 1.71 • n=206 Participants
|
0.76 t-score
STANDARD_DEVIATION 1.82 • n=7 Participants
|
|
BMD T-score: Total Hip
|
0.13 t-score
STANDARD_DEVIATION 1.01 • n=99 Participants
|
0.00 t-score
STANDARD_DEVIATION 0.90 • n=107 Participants
|
0.24 t-score
STANDARD_DEVIATION 1.17 • n=206 Participants
|
0.12 t-score
STANDARD_DEVIATION 1.04 • n=7 Participants
|
|
BMD T-score: Femoral Neck
|
-0.69 t-score
STANDARD_DEVIATION 0.86 • n=99 Participants
|
-0.66 t-score
STANDARD_DEVIATION 0.88 • n=107 Participants
|
-0.46 t-score
STANDARD_DEVIATION 1.03 • n=206 Participants
|
-0.60 t-score
STANDARD_DEVIATION 0.93 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework.
An analysis of covariance (ANCOVA) model is used for analysis.
Outcome measures
| Measure |
Placebo
n=126 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
|
-0.22 percentage of HbA1c
Standard Error 0.080
|
-0.66 percentage of HbA1c
Standard Error 0.077
|
-0.67 percentage of HbA1c
Standard Error 0.079
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety population included all randomized participants who had received at least one dose of investigational medicinal product (IMP). Missing data are imputed using a pattern-based imputation method.
An ANCOVA model is used for analysis.
Outcome measures
| Measure |
Placebo
n=125 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26
|
0.37 percent change
Standard Error 0.327
|
0.13 percent change
Standard Error 0.323
|
0.22 percent change
Standard Error 0.327
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety population included all randomized participants who had received at least one dose of IMP. Missing data are imputed using a pattern-based imputation method.
An ANCOVA model is used for analysis.
Outcome measures
| Measure |
Placebo
n=125 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26
|
-0.36 percent change
Standard Error 0.259
|
-0.22 percent change
Standard Error 0.220
|
-0.16 percent change
Standard Error 0.223
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: Safety population included all randomized participants who had received at least one dose of IMP. Missing data are imputed using a pattern-based imputation method.
An ANCOVA model is used for analysis.
Outcome measures
| Measure |
Placebo
n=125 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26
|
-0.94 percent change
Standard Error 0.379
|
-0.20 percent change
Standard Error 0.332
|
-0.62 percent change
Standard Error 0.338
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework.
An ANCOVA model is used for analysis.
Outcome measures
| Measure |
Placebo
n=126 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 26
|
-0.46 kilogram (kg)
Standard Error 0.261
|
-2.37 kilogram (kg)
Standard Error 0.258
|
-2.16 kilogram (kg)
Standard Error 0.264
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework.
An ANCOVA model is used for analysis.
Outcome measures
| Measure |
Placebo
n=126 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
|
-7.274 milligram per deciliter (mg/dL)
Standard Error 3.6064
|
-26.165 milligram per deciliter (mg/dL)
Standard Error 3.4656
|
-28.607 milligram per deciliter (mg/dL)
Standard Error 3.5912
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using washout imputation method under the missing not at random framework.
An ANCOVA model is used for analysis.
Outcome measures
| Measure |
Placebo
n=126 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
|
-0.80 millimeter of mercury (mmHg)
Standard Error 1.149
|
-1.61 millimeter of mercury (mmHg)
Standard Error 1.130
|
-1.97 millimeter of mercury (mmHg)
Standard Error 1.165
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures.
Outcome measures
| Measure |
Placebo
n=126 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26
|
9.5 percentage of participants
|
20.0 percentage of participants
|
21.6 percentage of participants
|
SECONDARY outcome
Timeframe: up to 106 weeksPopulation: Safety population included all randomized participants who had received at least one dose of IMP.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Placebo
n=125 Participants
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 Participants
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
80.0 percentage of participants
|
82.4 percentage of participants
|
82.4 percentage of participants
|
Adverse Events
Placebo
Serious events: 20 serious events
Other events: 66 other events
Deaths: 1 deaths
Sotagliflozin 200 mg
Serious events: 10 serious events
Other events: 67 other events
Deaths: 0 deaths
Sotagliflozin 400 mg
Serious events: 9 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=125 participants at risk
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 participants at risk
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 participants at risk
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Cardiac disorders
Coronary artery disease
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Cardiac disorders
Myocardial infarction
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
General disorders
Pyrexia
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Localised infection
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Maisonneuve fracture
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Investigations
Alanine aminotransferase increased
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
2/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Nervous system disorders
Spinal claudication
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Renal and urinary disorders
Calculus bladder
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
0.00%
0/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
Other adverse events
| Measure |
Placebo
n=125 participants at risk
Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.
|
Sotagliflozin 200 mg
n=125 participants at risk
Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
Sotagliflozin 400 mg
n=125 participants at risk
Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
7/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
4.8%
6/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
12.8%
16/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Influenza
|
1.6%
2/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
8.8%
11/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
4.0%
5/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
12/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
7.2%
9/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
8.8%
11/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.2%
24/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
12.0%
15/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
2.4%
3/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
12.0%
15/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
8.8%
11/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
11.2%
14/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Fall
|
7.2%
9/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
3.2%
4/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
5.6%
7/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Investigations
Bone density decreased
|
4.0%
5/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
8.0%
10/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
5.6%
7/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.2%
9/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
9.6%
12/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
5.6%
7/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
6.4%
8/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
8.0%
10/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
9/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
4.0%
5/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
4.0%
5/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Nervous system disorders
Headache
|
6.4%
8/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
2.4%
3/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
4.0%
5/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Renal and urinary disorders
Pollakiuria
|
0.80%
1/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
5.6%
7/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
2.4%
3/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
|
Vascular disorders
Hypertension
|
5.6%
7/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
1.6%
2/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
4.0%
5/125 • First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks
The safety population included all randomized participants who had received at least one dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER