Trial Outcomes & Findings for Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (NCT NCT02384941)
NCT ID: NCT02384941
Last Updated: 2020-02-12
Results Overview
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from Baseline (a lower A1C value at Week 24) indicates an improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
793 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2020-02-12
Participant Flow
The study was conducted at 75 study sites in 2 countries from March 2015 to February 2017.
1099 participants were screened and 793 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy were randomized into three treatment groups: Placebo, Sotagliflozin 200 mg, Sotagliflozin 400 mg.
Participant milestones
| Measure |
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
268
|
263
|
262
|
|
Overall Study
COMPLETED
|
218
|
228
|
221
|
|
Overall Study
NOT COMPLETED
|
50
|
35
|
41
|
Reasons for withdrawal
| Measure |
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
13
|
17
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
|
Overall Study
Non-Compliance With Study Drug
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
26
|
19
|
20
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
|
Overall Study
Other than specified above
|
4
|
0
|
1
|
Baseline Characteristics
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=268 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=263 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=262 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Total
n=793 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 13.48 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 13.12 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 13.11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
410 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
383 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
244 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
731 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Hemoglobin A1C (A1C)
|
7.54 percentage of A1C
STANDARD_DEVIATION 0.712 • n=5 Participants
|
7.61 percentage of A1C
STANDARD_DEVIATION 0.735 • n=7 Participants
|
7.56 percentage of A1C
STANDARD_DEVIATION 0.724 • n=5 Participants
|
7.57 percentage of A1C
STANDARD_DEVIATION 0.723 • n=4 Participants
|
|
Body Weight
|
87.30 kilograms (kg)
STANDARD_DEVIATION 17.709 • n=5 Participants
|
86.96 kilograms (kg)
STANDARD_DEVIATION 18.539 • n=7 Participants
|
86.50 kilograms (kg)
STANDARD_DEVIATION 18.004 • n=5 Participants
|
86.92 kilograms (kg)
STANDARD_DEVIATION 18.065 • n=4 Participants
|
|
Baseline Daily Total Insulin Dose
|
0.74 International Unit per kilogram (IU/kg)
STANDARD_DEVIATION 0.357 • n=5 Participants
|
0.72 International Unit per kilogram (IU/kg)
STANDARD_DEVIATION 0.386 • n=7 Participants
|
0.72 International Unit per kilogram (IU/kg)
STANDARD_DEVIATION 0.335 • n=5 Participants
|
0.73 International Unit per kilogram (IU/kg)
STANDARD_DEVIATION 0.360 • n=4 Participants
|
|
Body Mass Index (BMI)
|
29.55 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 5.188 • n=5 Participants
|
29.81 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 5.686 • n=7 Participants
|
29.63 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 5.297 • n=5 Participants
|
29.66 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 5.387 • n=4 Participants
|
|
Duration of Diabetes
|
24.2 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 13.15 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Modified intent to treat (mITT) analysis set included all randomly assigned participants who have taken at least 1 dose of study drug. Here, "Overall Number of Participants" Analyzed signified participants with available data for this outcome measure.
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from Baseline (a lower A1C value at Week 24) indicates an improvement.
Outcome measures
| Measure |
Placebo
n=246 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=245 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=242 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Change From Baseline in A1C at Week 24
|
-0.07 percentage of A1C
Standard Error 0.036
|
-0.43 percentage of A1C
Standard Error 0.036
|
-0.48 percentage of A1C
Standard Error 0.036
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set.
Blood samples were collected for the assessment of Hemoglobin A1C to determine the participants with A1C value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.
Outcome measures
| Measure |
Placebo
n=268 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=263 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=262 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24
|
21.6 percentage of participants
|
33.5 percentage of participants
|
43.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set. Here, "Overall Number of Participants Analyzed" signified participants with available data for this outcome measure.
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.
Outcome measures
| Measure |
Placebo
n=244 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=245 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=242 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Absolute Change From Baseline in Body Weight at Week 24
|
0.78 kilograms (kg)
Standard Error 0.187
|
-1.57 kilograms (kg)
Standard Error 0.188
|
-2.67 kilograms (kg)
Standard Error 0.188
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set. Here, "Overall Number of Participants Analyzed" signified participants with available data for this outcome measure.
The mean bolus insulin dose in international units per day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative change from Baseline indicated a reduction in the amount of bolus insulin used between Baseline and Week 24.
Outcome measures
| Measure |
Placebo
n=241 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=242 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=242 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24
|
-0.84 IU/day
Standard Error 0.688
|
-2.33 IU/day
Standard Error 0.692
|
-4.13 IU/day
Standard Error 0.692
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set. Here, "Overall Number of Participants Analyzed" signified participants with available data for this outcome measure.
The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose at Week 24 compared to baseline.
Outcome measures
| Measure |
Placebo
n=245 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=245 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=242 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
|
0.21 millimole per liter (mmol/L)
Standard Error 0.191
|
-0.34 millimole per liter (mmol/L)
Standard Error 0.192
|
-0.78 millimole per liter (mmol/L)
Standard Error 0.193
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set. Here, "Overall Number of Participants Analyzed" signified participants with available data for this outcome measure.
DTSQs is a diabetes-specific measure used to evaluate overall treatment satisfaction and perception of hyperglycemia and hypoglycemia events. It consists of 8 items and the response categories for all items were on a 7-point likert scale.The DTSQs response options ranged from 0 (very dissatisfied) to 6 (very satisfied). Responses to item 1, 4, 5, 6, 7 and 8 were summarized to determine the total treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied), with a higher score corresponding to higher satisfaction . LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=237 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=240 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=233 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24
|
-0.4 units on a scale
Standard Error 0.30
|
2.1 units on a scale
Standard Error 0.31
|
2.1 units on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set. Here, "Overall Number of Participants Analyzed" signified participants with available data for this outcome measure.
The DDS2 is a 2-item diabetes distress screening instrument where respondents rated, on a 6-point scale, the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 (not a problem) to 12 (very serious problem), with higher score corresponding to higher distress. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=243 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=244 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=242 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24
|
0.3 units on a scale
Standard Error 0.11
|
-0.4 units on a scale
Standard Error 0.11
|
-0.5 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Analysis performed on mITT analysis set. Here, "Overall Number of Participants Analyzed" signified participants with available data for this outcome measure.
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24.
Outcome measures
| Measure |
Placebo
n=244 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=245 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=242 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 24
|
0.92 percent change
Standard Error 0.212
|
-1.87 percent change
Standard Error 0.213
|
-3.10 percent change
Standard Error 0.213
|
Adverse Events
Placebo
Serious events: 20 serious events
Other events: 129 other events
Deaths: 1 deaths
Sotagliflozin 200 mg
Serious events: 27 serious events
Other events: 132 other events
Deaths: 0 deaths
Sotagliflozin 400 mg
Serious events: 29 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=268 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=263 participants at risk
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=262 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.37%
1/268 • Number of events 3 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
2/268 • Number of events 2 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.76%
2/263 • Number of events 2 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.1%
3/268 • Number of events 3 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
4.6%
12/263 • Number of events 13 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
5.3%
14/262 • Number of events 14 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
5/268 • Number of events 7 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
1.1%
3/263 • Number of events 5 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
1.5%
4/262 • Number of events 4 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/268 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.38%
1/262 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.37%
1/268 • Number of events 1 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
0.00%
0/262 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=268 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 200 mg
n=263 participants at risk
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
Sotagliflozin 400 mg
n=262 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 24 weeks followed by a 28 week extension period.
|
|---|---|---|---|
|
Investigations
Blood ketone body increased
|
0.75%
2/268 • Number of events 2 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
3.8%
10/263 • Number of events 20 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
5.3%
14/262 • Number of events 19 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
10/268 • Number of events 13 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
2.3%
6/263 • Number of events 6 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
6.9%
18/262 • Number of events 18 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
19/268 • Number of events 21 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
8.4%
22/263 • Number of events 26 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
11.1%
29/262 • Number of events 41 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
18/268 • Number of events 21 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
6.5%
17/263 • Number of events 23 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
6.9%
18/262 • Number of events 24 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.9%
13/268 • Number of events 16 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
5.3%
14/263 • Number of events 20 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
3.4%
9/262 • Number of events 10 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.0%
43/268 • Number of events 52 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
12.5%
33/263 • Number of events 38 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
12.6%
33/262 • Number of events 46 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
18/268 • Number of events 23 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
9.5%
25/263 • Number of events 34 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
3.4%
9/262 • Number of events 14 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.8%
29/268 • Number of events 33 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
12.9%
34/263 • Number of events 41 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
9.2%
24/262 • Number of events 29 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.2%
6/268 • Number of events 8 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
4.9%
13/263 • Number of events 18 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
8.0%
21/262 • Number of events 23 • Baseline (Day 1) to 30 days after end of treatment or end of follow up (Up to 53 Weeks)
Analysis performed on safety population which includes participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER