Trial Outcomes & Findings for Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy (NCT NCT02926937)
NCT ID: NCT02926937
Last Updated: 2021-06-21
Results Overview
An analysis of covariance (ANCOVA) model was used for the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
399 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2021-06-21
Participant Flow
Participants took part in the study at 70 investigative sites in the United States, Canada, Mexico, from 11 November 2016 to 17 May 2019.
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.
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 (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
Sotagliflozin 400 mg
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.
|
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, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
142
|
107
|
|
Overall Study
COMPLETED
|
131
|
127
|
96
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
11
|
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 (QD), before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
Sotagliflozin 400 mg
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.
|
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, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Poor Compliance to Protocol
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
0
|
|
Overall Study
At the Participant's own Request
|
11
|
5
|
8
|
|
Overall Study
Reason not Specified
|
3
|
4
|
2
|
Baseline Characteristics
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
Sotagliflozin 200 mg
n=107 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, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
206 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
99 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
7 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
100 participants
n=7 Participants
|
63 participants
n=5 Participants
|
259 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
43 participants
n=5 Participants
|
29 participants
n=7 Participants
|
37 participants
n=5 Participants
|
109 participants
n=4 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.11 percentage of HbA1c
STANDARD_DEVIATION 0.88 • n=5 Participants
|
8.14 percentage of HbA1c
STANDARD_DEVIATION 0.92 • n=7 Participants
|
8.00 percentage of HbA1c
STANDARD_DEVIATION 0.81 • n=5 Participants
|
8.09 percentage of HbA1c
STANDARD_DEVIATION 0.87 • n=4 Participants
|
|
Systolic Blood Pressure (SBP)
|
127.27 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.08 • n=5 Participants
|
128.70 millimeter of mercury (mmHg)
STANDARD_DEVIATION 4.80 • n=7 Participants
|
128.08 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.08 • n=5 Participants
|
128.00 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.70 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: 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.
An analysis of covariance (ANCOVA) model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo)
|
-0.34 percentage of HbA1c
Standard Error 0.120
|
-1.03 percentage of HbA1c
Standard Error 0.122
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo)
|
-0.591 millimole per liter (mmol/L)
Standard Error 0.1943
|
-1.156 millimole per liter (mmol/L)
Standard Error 0.1964
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=110 Participants
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.
|
Sotagliflozin 400 mg
n=107 Participants
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.
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo)
|
-0.500 mmol/L
Standard Error 0.2443
|
-0.847 mmol/L
Standard Error 0.2477
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo)
|
-0.201 mmol/L
Standard Error 0.2739
|
-1.756 mmol/L
Standard Error 0.2719
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=55 Participants
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.
|
Sotagliflozin 400 mg
n=48 Participants
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.
|
|---|---|---|
|
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)
|
-4.45 mmHg
Standard Error 2.419
|
-7.96 mmHg
Standard Error 2.282
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo)
|
-0.57 mmHg
Standard Error 1.088
|
-1.35 mmHg
Standard Error 1.116
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=110 Participants
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.
|
Sotagliflozin 400 mg
n=107 Participants
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.
|
|---|---|---|
|
Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo)
|
-1.62 mmHg
Standard Error 1.215
|
-4.82 mmHg
Standard Error 1.211
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo)
|
-0.79 kilogram (Kg)
Standard Error 0.373
|
-2.33 kilogram (Kg)
Standard Error 0.379
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=110 Participants
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.
|
Sotagliflozin 400 mg
n=107 Participants
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.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo)
|
-0.52 kg
Standard Error 0.509
|
-1.69 kg
Standard Error 0.518
|
SECONDARY outcome
Timeframe: Week 26Population: 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.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo)
|
10.7 percentage of participants
|
23.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: 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.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo)
|
28.0 percentage of participants
|
47.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Placebo
n=110 Participants
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.
|
Sotagliflozin 400 mg
n=107 Participants
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.
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo)
|
-0.26 percentage of HbA1c
Standard Error 0.143
|
-0.93 percentage of HbA1c
Standard Error 0.148
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26Population: Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1.
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.
Outcome measures
| Measure |
Placebo
n=150 Participants
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.
|
Sotagliflozin 400 mg
n=142 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo)
Any hypoglycemia
|
2.7 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo)
Documented symptomatic hypoglycemia
|
1.3 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo)
Severe or documented symptomatic hypoglycemia
|
1.3 percentage of participants
|
0.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 26Population: Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1.
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.
Outcome measures
| Measure |
Placebo
n=110 Participants
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.
|
Sotagliflozin 400 mg
n=107 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo)
Any hypoglycemia
|
2.7 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo)
Documented symptomatic hypoglycemia
|
0.9 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo)
Severe or documented symptomatic hypoglycemia
|
0.9 percentage of participants
|
0.9 percentage of participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Sotagliflozin 400 mg
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Sotagliflozin 200 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=150 participants at risk
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.
|
Sotagliflozin 400 mg
n=142 participants at risk
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.
|
Sotagliflozin 200 mg
n=107 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, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.70%
1/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Gastrointestinal disorders
Colitis
|
0.67%
1/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.67%
1/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.67%
1/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.93%
1/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.93%
1/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.93%
1/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.93%
1/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Psychiatric disorders
Depression
|
0.67%
1/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Psychiatric disorders
Suicide attempt
|
0.67%
1/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.70%
1/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.93%
1/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.70%
1/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
0.00%
0/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
Other adverse events
| Measure |
Placebo
n=150 participants at risk
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.
|
Sotagliflozin 400 mg
n=142 participants at risk
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.
|
Sotagliflozin 200 mg
n=107 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, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
5/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
6.3%
9/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
4.7%
5/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Infections and infestations
Urinary tract infection
|
4.7%
7/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
5.6%
8/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
2.8%
3/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
|
Nervous system disorders
Headache
|
6.0%
9/150 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
2.8%
4/142 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (IMP).
|
6.5%
7/107 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks
Safety population included all randomized participants who had received at least one dose of double-blind investigational medicinal product (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