Trial Outcomes & Findings for Dose-ranging Study in Patients With Type 1 Diabetes Mellitus (NCT NCT02459899)
NCT ID: NCT02459899
Last Updated: 2020-02-12
Results Overview
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2020-02-12
Participant Flow
The study was conducted at 17 centers in the United States from 10 July 2015 to 26 August 2016.
207 participants were screened and 141 participants with Type 1 diabetes mellitus who had inadequate glycemic control with insulin therapy alone, were randomized equally into four treatment groups: sotagliflozin 75 milligrams (mg), sotagliflozin 200 mg, sotagliflozin 400 mg or placebo.
Participant milestones
| Measure |
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
29
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
1
|
|
Overall Study
Non-compliance with the treatment
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
Baseline Characteristics
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=35 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=35 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=35 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 14.01 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 15.36 • n=4 Participants
|
45.6 years
STANDARD_DEVIATION 13.29 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
|
Body Weight
|
91.92 kilograms
STANDARD_DEVIATION 19.681 • n=5 Participants
|
79.97 kilograms
STANDARD_DEVIATION 14.358 • n=7 Participants
|
82.90 kilograms
STANDARD_DEVIATION 17.140 • n=5 Participants
|
86.95 kilograms
STANDARD_DEVIATION 20.857 • n=4 Participants
|
85.48 kilograms
STANDARD_DEVIATION 18.557 • n=21 Participants
|
|
Daily Total Insulin Dose
|
0.68 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.306 • n=5 Participants
|
0.65 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.229 • n=7 Participants
|
0.70 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.298 • n=5 Participants
|
0.77 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.409 • n=4 Participants
|
0.70 International units per kilogram (IU/kg)
STANDARD_DEVIATION 0.315 • n=21 Participants
|
|
Hemoglobin A1C (A1c)
|
7.95 percentage of A1C
STANDARD_DEVIATION 0.849 • n=5 Participants
|
8.00 percentage of A1C
STANDARD_DEVIATION 0.839 • n=7 Participants
|
8.07 percentage of A1C
STANDARD_DEVIATION 0.926 • n=5 Participants
|
8.05 percentage of A1C
STANDARD_DEVIATION 0.735 • n=4 Participants
|
8.02 percentage of A1C
STANDARD_DEVIATION 0.832 • n=21 Participants
|
|
Body Mass Index
|
31.81 kilograms per meter square
STANDARD_DEVIATION 5.763 • n=5 Participants
|
27.41 kilograms per meter square
STANDARD_DEVIATION 5.016 • n=7 Participants
|
28.01 kilograms per meter square
STANDARD_DEVIATION 4.707 • n=5 Participants
|
29.37 kilograms per meter square
STANDARD_DEVIATION 5.849 • n=4 Participants
|
29.17 kilograms per meter square
STANDARD_DEVIATION 5.569 • n=21 Participants
|
|
Duration of Diabetes
|
26.9 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 13.04 • n=7 Participants
|
23.4 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
24.0 years
STANDARD_DEVIATION 14.96 • n=4 Participants
|
24.1 years
STANDARD_DEVIATION 13.66 • n=21 Participants
|
|
Insulin delivery method in Participants
continuous subcutaneous insulin infusion (CSII)
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Insulin delivery method in Participants
multiple daily injection (MDI)
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Outcome measures
| Measure |
Placebo
n=33 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=29 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=35 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=33 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
|
-0.35 percentage of A1C
Standard Error 0.096
|
-0.60 percentage of A1C
Standard Error 0.100
|
-0.84 percentage of A1C
Standard Error 0.095
|
-0.73 percentage of A1C
Standard Error 0.096
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.
Outcome measures
| Measure |
Placebo
n=32 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=27 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=25 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=32 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal
|
-0.2 milligrams per deciliter (mg/dL)
Standard Error 12.51
|
-20.5 milligrams per deciliter (mg/dL)
Standard Error 13.66
|
-27.6 milligrams per deciliter (mg/dL)
Standard Error 14.16
|
-49.7 milligrams per deciliter (mg/dL)
Standard Error 12.51
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Outcome measures
| Measure |
Placebo
n=33 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=29 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=35 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=33 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Body Weight to Week 12
|
1.13 kilograms
Standard Error 0.425
|
-0.16 kilograms
Standard Error 0.441
|
-1.24 kilograms
Standard Error 0.417
|
-1.48 kilograms
Standard Error 0.422
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Outcome measures
| Measure |
Placebo
n=33 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=29 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=35 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=33 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight to Week 12
|
1.26 percent change
Standard Error 0.535
|
0.11 percent change
Standard Error 0.556
|
-1.47 percent change
Standard Error 0.531
|
-1.61 percent change
Standard Error 0.538
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.
Outcome measures
| Measure |
Placebo
n=23 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=24 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=23 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=24 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion
|
0.2555 grams per day
Standard Error 10.53532
|
42.0185 grams per day
Standard Error 10.52465
|
57.9850 grams per day
Standard Error 10.51367
|
70.7058 grams per day
Standard Error 10.28691
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.
Outcome measures
| Measure |
Placebo
n=33 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
|
Sotagliflozin 75 mg
n=29 Participants
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=34 Participants
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=33 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Fasting Plasma Glucose
|
-10.8 mg/dL
Standard Error 8.99
|
-19.4 mg/dL
Standard Error 9.55
|
-19.8 mg/dL
Standard Error 8.85
|
-32.2 mg/dL
Standard Error 8.99
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Sotagliflozin 75 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Sotagliflozin 200 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Sotagliflozin 400 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally, for 12 weeks.
|
Sotagliflozin 75 mg
n=35 participants at risk
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=35 participants at risk
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=35 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Deafness neurosensory
|
2.8%
1/36 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/36 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/36 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/36 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally, for 12 weeks.
|
Sotagliflozin 75 mg
n=35 participants at risk
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 200 mg
n=35 participants at risk
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally, for 12 weeks.
|
Sotagliflozin 400 mg
n=35 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/36 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 3 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
3/36 • Number of events 3 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
2/36 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
11.1%
4/36 • Number of events 6 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had received at least 1 dose of study drug.
|
0.00%
0/35 • Adverse event (AE) data were collected from first dose up to 30 days after date of last dose of double-blind study treatment (up to 114 days)
Analysis was performed on safety population which included all randomized participants who had 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