Trial Outcomes & Findings for Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin (NCT NCT03351478)
NCT ID: NCT03351478
Last Updated: 2021-05-11
Results Overview
An analysis of covariance (ANCOVA) model was used for the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
770 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2021-05-11
Participant Flow
Participants took part in the study at 160 investigative sites in Bulgaria, Canada, Czechia, France, Italy, Latvia, Mexico, Russian Federation, Slovakia, Spain, United Kingdom, and the United States from 27 November 2017 to 16 May 2019.
Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled in 1 of 3 treatment groups, Sotagliflozin, Empagliflozin, or Placebo. Participants were randomly assigned in the ratio of 2:2:1 to these reporting groups.
Participant milestones
| Measure |
Sotagliflozin 400 mg
Following a 2-week run-in period, sotagliflozin 400 milligrams (mg) administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
307
|
309
|
154
|
|
Overall Study
COMPLETED
|
293
|
292
|
147
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
7
|
Reasons for withdrawal
| Measure |
Sotagliflozin 400 mg
Following a 2-week run-in period, sotagliflozin 400 milligrams (mg) administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Overall Study
At the subject's own request
|
11
|
12
|
5
|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
|
Overall Study
Poor compliance to protocol
|
1
|
0
|
0
|
|
Overall Study
Reason not Specified
|
1
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
Baseline characteristics by cohort
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
Total
n=770 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
374 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
251 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
615 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
256 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
650 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.23 percentage of HbA1c
STANDARD_DEVIATION 0.84 • n=5 Participants
|
8.21 percentage of HbA1c
STANDARD_DEVIATION 0.93 • n=7 Participants
|
8.21 percentage of HbA1c
STANDARD_DEVIATION 0.93 • n=5 Participants
|
8.22 percentage of HbA1c
STANDARD_DEVIATION 0.90 • n=4 Participants
|
|
Systolic Blood Pressure (SBP)
|
134.55 millimeter of mercury (mmHg)
STANDARD_DEVIATION 13.56 • n=5 Participants
|
131.64 millimeter of mercury (mmHg)
STANDARD_DEVIATION 12.18 • n=7 Participants
|
133.19 millimeter of mercury (mmHg)
STANDARD_DEVIATION 12.53 • n=5 Participants
|
133.11 millimeter of mercury (mmHg)
STANDARD_DEVIATION 12.87 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.
An analysis of covariance (ANCOVA) model was used for the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26
|
-0.7 percentage of HbA1c
Standard Error 0.1
|
-0.8 percentage of HbA1c
Standard Error 0.1
|
-0.3 percentage of HbA1c
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants from the ITT population, all randomized participants with data available at the given time point for analysis. Missing data was imputed using washout imputation method.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=146 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=151 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=84 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg
|
-5.6 mmHg
Standard Error 1.3
|
-6.7 mmHg
Standard Error 1.3
|
-3.5 mmHg
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population included all randomized participants. Missing data was imputed using washout imputation method under the missing not at random framework.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26
|
-1.3 millimole per liter (mmol/L)
Standard Error 0.2
|
-1.2 millimole per liter (mmol/L)
Standard Error 0.9
|
-0.4 millimole per liter (mmol/L)
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
|
-1.3 mmol/L
Standard Error 0.2
|
-1.6 mmol/L
Standard Error 0.2
|
-0.5 mmol/L
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 26
|
-2.7 kilogram (kg)
Standard Error 0.3
|
-3.2 kilogram (kg)
Standard Error 0.3
|
-0.5 kilogram (kg)
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all randomized participants. Missing data was imputed using the retrieved dropouts imputation method.
An ANCOVA model was used for the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Sitting SBP at Week 12 for All Participants
|
-1.7 mmHg
Standard Error 0.8
|
-2.8 mmHg
Standard Error 0.8
|
-0.4 mmHg
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants. Missing data at Week 26 were assigned a status of nonresponder in the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HbA1c <6.5% at Week 26
|
12.1 percentage of participants
|
11.7 percentage of participants
|
3.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population included all randomized participants. Missing data at Week 26 were assigned a status of nonresponder in the analysis.
Outcome measures
| Measure |
Sotagliflozin 400 mg
n=307 Participants
Following a 2-week run-in period, sotagliflozin 400 mg administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 Participants
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 Participants
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0% at Week 26
|
32.6 percentage of participants
|
35.6 percentage of participants
|
15.6 percentage of participants
|
Adverse Events
Sotagliflozin 400 mg
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Empagliflozin 25 mg
Serious events: 13 serious events
Other events: 68 other events
Deaths: 1 deaths
Placebo
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sotagliflozin 400 mg
n=307 participants at risk
Following a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 participants at risk
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 participants at risk
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haematoma
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
2/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
2/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
1.3%
2/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.32%
1/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Sotagliflozin 400 mg
n=307 participants at risk
Following a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
|
Empagliflozin 25 mg
n=309 participants at risk
Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
|
Placebo
n=154 participants at risk
Following a 2-week run-in period, placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.3%
7/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.6%
8/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
3.9%
6/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.98%
3/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
1.6%
5/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
3.9%
6/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
10/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.6%
8/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
3.2%
5/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
6/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.97%
3/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.6%
4/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
6/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
1.9%
6/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
5.8%
9/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Any Hypoglycaemia
|
0.65%
2/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.9%
9/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
4.5%
7/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Documented Symptomatic Hypoglycaemia
|
0.33%
1/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.6%
8/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
1.9%
3/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Genital infection fungal
|
2.3%
7/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
1.6%
5/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
1.6%
5/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.9%
9/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
3.2%
5/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
12/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
6.5%
20/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
3.2%
5/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
11/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
2.6%
8/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
1.3%
2/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.6%
5/307 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
3.2%
10/309 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
0.65%
1/154 • First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks)
Safety population included all randomized participants who received at least one dose of study drug.
|
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