Trial Outcomes & Findings for A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure (NCT NCT03152552)
NCT ID: NCT03152552
Last Updated: 2019-08-28
Results Overview
Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this primary endpoint due to early study termination. Only descriptive statistics are presented.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2019-08-28
Participant Flow
Patients were randomized in a 1:1:2:2:2 ratio to one of 5 regimens (LIK066 2.5mg, 10mg, 50 mg, EMPA 25mg, Pbo) at Visit 201 (randomization) with a plan to be treated for 36 weeks.
A placebo run-in period (Epoch 2) running up to 2 weeks before randomization was used to assess eligibility
Participant milestones
| Measure |
LIK066 2.5mg
LIK066 2.5mg once daily
|
LIK066 10mg
LIk066 10mg once daily
|
LIK066 50mg
LIK066 50mg once daily
|
EMPA 25mg
Empagliflozin 25 mg once daily
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Treatment Period 1 (12 Weeks)
STARTED
|
15
|
16
|
31
|
30
|
33
|
|
Treatment Period 1 (12 Weeks)
Full Analysis Set (FAS)
|
15
|
16
|
30
|
30
|
33
|
|
Treatment Period 1 (12 Weeks)
COMPLETED
|
7
|
5
|
10
|
10
|
12
|
|
Treatment Period 1 (12 Weeks)
NOT COMPLETED
|
8
|
11
|
21
|
20
|
21
|
|
Treatment Period 2 (24 Weeks)
STARTED
|
7
|
5
|
9
|
9
|
11
|
|
Treatment Period 2 (24 Weeks)
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (24 Weeks)
NOT COMPLETED
|
6
|
5
|
9
|
9
|
11
|
Reasons for withdrawal
| Measure |
LIK066 2.5mg
LIK066 2.5mg once daily
|
LIK066 10mg
LIk066 10mg once daily
|
LIK066 50mg
LIK066 50mg once daily
|
EMPA 25mg
Empagliflozin 25 mg once daily
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Treatment Period 1 (12 Weeks)
Death
|
0
|
1
|
0
|
0
|
1
|
|
Treatment Period 1 (12 Weeks)
Protocol deviation
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1 (12 Weeks)
Study terminated by sponsor
|
8
|
9
|
19
|
19
|
20
|
|
Treatment Period 1 (12 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1 (12 Weeks)
Technical problems
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1 (12 Weeks)
Subject/guardian decision
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2 (24 Weeks)
Study terminated by sponsor
|
6
|
5
|
9
|
9
|
11
|
Baseline Characteristics
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
Baseline characteristics by cohort
| Measure |
LIK066 2.5mg
n=15 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=16 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=30 Participants
LIK066 50mg once daily
|
EMPA 25mg
n=30 Participants
Empagliflozin 25 mg once daily
|
Placebo
n=33 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.2 Years
STANDARD_DEVIATION 7.10 • n=5 Participants
|
69.8 Years
STANDARD_DEVIATION 9.69 • n=7 Participants
|
65.8 Years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
68.6 Years
STANDARD_DEVIATION 7.89 • n=4 Participants
|
67.8 Years
STANDARD_DEVIATION 10.93 • n=21 Participants
|
67.8 Years
STANDARD_DEVIATION 9.17 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
113 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms are considered per study primary objective.
Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this primary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=12 Participants
LIK066 50mg once daily
|
Placebo
n=16 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12
|
0.8 ratio
Interval 0.5 to 1.2
|
0.6 ratio
Interval 0.2 to 1.7
|
0.8 ratio
Interval 0.7 to 1.1
|
1.1 ratio
Interval 0.8 to 1.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
HbA1c was measured from a blood sample and analyzed using a National Glycohemoglobin Standardization Program (NGSP) certified method at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=12 Participants
LIK066 50mg once daily
|
Placebo
n=14 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=18 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36
Change from BL at Week 12
|
-0.29 Percentage (%)
Standard Deviation 0.836
|
-0.01 Percentage (%)
Standard Deviation 0.508
|
-0.58 Percentage (%)
Standard Deviation 0.335
|
-0.44 Percentage (%)
Standard Deviation 1.176
|
-0.04 Percentage (%)
Standard Deviation 0.913
|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36
Change from BL at Week 36
|
0.13 Percentage (%)
Standard Deviation 0.961
|
—
|
-0.60 Percentage (%)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
-1.83 Percentage (%)
Standard Deviation 0.321
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
FPG was measured from a blood sample after an overnight fast; patients were not allowed to eat or drink anything (except water) for at least 8 h before each study visit. Samples were analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=8 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=6 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=12 Participants
LIK066 50mg once daily
|
Placebo
n=13 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=15 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36
Change from BL at Week 12
|
-1.021 millimoles per litre (mmol/L)
Standard Deviation 1.0368
|
-2.041 millimoles per litre (mmol/L)
Standard Deviation 4.9772
|
-0.426 millimoles per litre (mmol/L)
Standard Deviation 2.1451
|
-1.303 millimoles per litre (mmol/L)
Standard Deviation 2.4386
|
-1.187 millimoles per litre (mmol/L)
Standard Deviation 3.9653
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36
Change from BL at Week 36
|
0.392 millimoles per litre (mmol/L)
Standard Deviation 1.1119
|
—
|
-1.200 millimoles per litre (mmol/L)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
-4.733 millimoles per litre (mmol/L)
Standard Deviation 0.3055
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
Body weight was measured to the nearest 0.1 kg on a calibrated scale (weight and bio-impedance measurements), provided by the sponsor. Exceptionally (e.g. if the body weight exceeded the limits of the provided scale) sites were allowed to use another scale for weight measurement as available, but during the study the same scale was to be used for the same patient. The measurement was performed with the study patient in underwear and without shoes. Indoor clothing was also acceptable, but measurements were to be done consistently (either with underwear or with indoor clothing) throughout the study. Voiding before weight measurement was required. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=13 Participants
LIK066 50mg once daily
|
Placebo
n=14 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=18 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Weeks 12 and 36
Change from BL at Week 12
|
-0.78 kilogram (kg)
Standard Deviation 2.734
|
-1.83 kilogram (kg)
Standard Deviation 1.402
|
-2.15 kilogram (kg)
Standard Deviation 2.397
|
-2.25 kilogram (kg)
Standard Deviation 1.894
|
-0.34 kilogram (kg)
Standard Deviation 2.115
|
|
Change From Baseline in Body Weight at Weeks 12 and 36
Change from BL at Week 36
|
-2.21 kilogram (kg)
Standard Deviation 1.586
|
—
|
-3.90 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
0.47 kilogram (kg)
Standard Deviation 6.158
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented
Outcome measures
| Measure |
LIK066 2.5mg
n=6 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=7 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=11 Participants
LIK066 50mg once daily
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=15 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36
Wk 12 Chge from BL
|
-0.77 Percentage of body fat mass
Standard Deviation 2.276
|
-1.51 Percentage of body fat mass
Standard Deviation 5.048
|
-0.32 Percentage of body fat mass
Standard Deviation 4.675
|
1.63 Percentage of body fat mass
Standard Deviation 3.639
|
-1.77 Percentage of body fat mass
Standard Deviation 7.812
|
|
Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36
Wk 36 Chge from BL
|
2.25 Percentage of body fat mass
Standard Deviation 1.485
|
—
|
0.20 Percentage of body fat mass
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
6.70 Percentage of body fat mass
Standard Deviation 20.082
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. Visceral fat levels were measured by Omron device. Levels ranged from 1 - 30 and are relative (not absolute) values. The Omron scale values are: 0 - 9 (normal), 10 - 14 (high) and 15 - 30 (very high). Visceral fat area ( 0 - approx. 300cm\^2, 1 inch = 2.54 cm) distribution with 30 levels.
Outcome measures
| Measure |
LIK066 2.5mg
n=7 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=7 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=11 Participants
LIK066 50mg once daily
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=15 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36
Wk 12 Chge from BL
|
-2.429 Level
Standard Deviation 4.6853
|
-2.857 Level
Standard Deviation 3.8914
|
-0.436 Level
Standard Deviation 4.6877
|
-0.417 Level
Standard Deviation 1.3114
|
-3.200 Level
Standard Deviation 4.7988
|
|
Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36
Wk 36 Chge from BL
|
0.000 Level
Standard Deviation 1.4142
|
—
|
0.000 Level
Standard Deviation NA
N/A: Not estimable due to insufficient number of participants with events
|
—
|
3.500 Level
Standard Deviation 7.7782
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented
Outcome measures
| Measure |
LIK066 2.5mg
n=6 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=6 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=10 Participants
LIK066 50mg once daily
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=14 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36
Wk 12 Chge from BL
|
-2.32 Percentage of body fat mass
Standard Deviation 7.063
|
-2.32 Percentage of body fat mass
Standard Deviation 5.774
|
-0.24 Percentage of body fat mass
Standard Deviation 2.022
|
-0.68 Percentage of body fat mass
Standard Deviation 2.454
|
1.64 Percentage of body fat mass
Standard Deviation 4.584
|
|
Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36
Wk 36 Chge from BL
|
-0.85 Percentage of body fat mass
Standard Deviation 1.344
|
—
|
-0.30 Percentage of body fat mass
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
-5.35 Percentage of body fat mass
Standard Deviation 13.223
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.
A whole body DXA scan was performed to assess Total Body Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Outcome measures
| Measure |
LIK066 2.5mg
n=1 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
LIk066 10mg once daily
|
LIK066 50mg
n=4 Participants
LIK066 50mg once daily
|
Placebo
n=4 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=1 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
BL Whole Body Minus Head Hologic
|
35.970 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
18.870 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
27.550 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
Wk 12 Whole Body - Hd Hologic Chge BL
|
-0.310 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
-4.280 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
Wk 36 Whole Body - Hd Hologic Chge BL
|
-3.800 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
-5.590 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
BL Whole Body Minus Head Lunar
|
—
|
—
|
29.350 kilogram (kg)
Standard Deviation 4.9403
|
37.455 kilogram (kg)
Standard Deviation 6.0175
|
—
|
|
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
Wk 12 Whole Body - Hd Lunar Chge BL
|
—
|
—
|
-1.260 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
1.190 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, no data was collected.
A whole body DXA scan was performed to assess Visceral Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.
A whole body DXA scan was performed to assess Lean Body Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Outcome measures
| Measure |
LIK066 2.5mg
n=1 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
LIk066 10mg once daily
|
LIK066 50mg
n=4 Participants
LIK066 50mg once daily
|
Placebo
n=4 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=1 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36
Wk 12 Whole Body - Hd Hologic Chge BL
|
-1.910 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
4.980 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36
Wk 36 Whole Body - Hd Hologic Chge BL
|
0.860 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
1.700 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36
Wk 12 Whole Body - Hd Lunar Chge BL
|
—
|
—
|
-1.290 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
-2.960 kilogram (kg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: FAS consisted of all randomized patients who were not mis-randomized. Analysis included patients who participated in the DXA sub-study. Due to early termination of the study, no data was collected.
A whole body DXA scan was performed to assess Total Body Water (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
Three sitting BP measurements were performed. At each visit, sitting BP was derived as the mean of three readings of the sitting SBP/DBP at that visit. Pre-planned statistical analyses were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=13 Participants
LIK066 50mg once daily
|
Placebo
n=14 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=18 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
SBP Change from BL at Week 12
|
5.15 millimeter of mercury (mmHg)
Standard Deviation 13.485
|
0.17 millimeter of mercury (mmHg)
Standard Deviation 15.373
|
-9.54 millimeter of mercury (mmHg)
Standard Deviation 16.884
|
-6.98 millimeter of mercury (mmHg)
Standard Deviation 15.031
|
-2.85 millimeter of mercury (mmHg)
Standard Deviation 11.967
|
|
Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
SBP Change from BL at Week 36
|
13.78 millimeter of mercury (mmHg)
Standard Deviation 17.900
|
—
|
-4.00 millimeter of mercury (mmHg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
0.00 millimeter of mercury (mmHg)
Standard Deviation 8.627
|
|
Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
DBP Change from BL at Week 12
|
-2.00 millimeter of mercury (mmHg)
Standard Deviation 6.582
|
4.50 millimeter of mercury (mmHg)
Standard Deviation 12.746
|
-4.46 millimeter of mercury (mmHg)
Standard Deviation 11.238
|
-1.81 millimeter of mercury (mmHg)
Standard Deviation 10.421
|
-2.00 millimeter of mercury (mmHg)
Standard Deviation 8.596
|
|
Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
DBP Change from BL at Week 36
|
1.12 millimeter of mercury (mmHg)
Standard Deviation 3.975
|
—
|
3.66 millimeter of mercury (mmHg)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
-0.44 millimeter of mercury (mmHg)
Standard Deviation 8.517
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
TG was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=6 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=12 Participants
LIK066 50mg once daily
|
Placebo
n=13 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=15 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36
% Change from BL at Week 12
|
-1.623 Percent change
Standard Deviation 35.2838
|
19.089 Percent change
Standard Deviation 31.4798
|
9.878 Percent change
Standard Deviation 30.3065
|
8.865 Percent change
Standard Deviation 35.0872
|
-2.979 Percent change
Standard Deviation 25.1049
|
|
Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36
% Change from BL at Week 36
|
4.324 Percent change
Standard Deviation 31.4438
|
—
|
14.286 Percent change
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
-1.111 Percent change
Standard Deviation 18.3586
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
Lipoproteins (High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol) were measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=7 Participants
LIK066 50mg once daily
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
LDL % Change from BL at Week 12
|
22.02 Percent change
Standard Deviation 35.466
|
2.62 Percent change
Standard Deviation 17.525
|
16.40 Percent change
Standard Deviation 36.928
|
22.24 Percent change
Standard Deviation 35.145
|
-1.59 Percent change
Standard Deviation 31.970
|
|
Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
LDL % Change from BL at Week 36
|
22.73 Percent change
Standard Deviation 31.690
|
—
|
-3.57 Percent change
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
0.22 Percent change
Standard Deviation 13.163
|
|
Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
HDL % Change from BL at Week 12
|
9.33 Percent change
Standard Deviation 16.735
|
-10.54 Percent change
Standard Deviation 20.590
|
0.26 Percent change
Standard Deviation 9.772
|
2.18 Percent change
Standard Deviation 12.179
|
-0.67 Percent change
Standard Deviation 13.322
|
|
Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
HDL % Change from BL at Week 36
|
10.70 Percent change
Standard Deviation 16.257
|
—
|
0.00 Percent change
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
35.00 Percent change
Standard Deviation 49.497
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: FAS consisted of all randomized patients who were not mis-randomized. Analysis included patients who participated in the study. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the study. 'Number Analyzed' = number of participants with data available.
Total Cholesterol was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=7 Participants
LIK066 50mg once daily
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=12 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36
% Change from BL at Week 12
|
9.69 Percent change
Standard Deviation 23.892
|
-2.66 Percent change
Standard Deviation 13.202
|
6.32 Percent change
Standard Deviation 22.667
|
10.83 Percent change
Standard Deviation 11.330
|
1.46 Percent change
Standard Deviation 16.741
|
|
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36
% Change from BL at Week 36
|
14.72 Percent change
Standard Deviation 13.147
|
—
|
2.04 Percent change
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
10.27 Percent change
Standard Deviation 28.326
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
hs-CRP is an inflammation biomarker. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=7 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=7 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=7 Participants
LIK066 50mg once daily
|
Placebo
n=11 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=10 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36
Change from BL at Week 12
|
0.543 milligram per litre (mg/L)
Interval 0.086 to 3.446
|
0.722 milligram per litre (mg/L)
Interval 0.157 to 3.321
|
1.997 milligram per litre (mg/L)
Interval 0.758 to 5.263
|
0.714 milligram per litre (mg/L)
Interval 0.353 to 1.443
|
1.018 milligram per litre (mg/L)
Interval 0.661 to 1.566
|
|
Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36
Change from BL at Week 36
|
0.953 milligram per litre (mg/L)
Interval 0.221 to 4.112
|
—
|
0.620 milligram per litre (mg/L)
NA: Not estimable due to insufficient number of participants with events
|
—
|
0.578 milligram per litre (mg/L)
Interval 0.172 to 1.945
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: FAS consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the 24 hour urine collection sub-study. 'Number Analyzed' = number of participants with data available.
UGE was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.
Outcome measures
| Measure |
LIK066 2.5mg
n=2 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=2 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=1 Participants
LIK066 50mg once daily
|
Placebo
n=2 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=5 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36
Change from BL at Week 12
|
256.245 millimoles per 24 hours (mmol/24h)
Standard Deviation 129.0682
|
346.360 millimoles per 24 hours (mmol/24h)
Standard Deviation 107.3671
|
305.110 millimoles per 24 hours (mmol/24h)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
254.270 millimoles per 24 hours (mmol/24h)
Standard Deviation 198.8243
|
84.778 millimoles per 24 hours (mmol/24h)
Standard Deviation 222.6565
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: FAS consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the 24 hour urine collection sub-study. 'Number Analyzed' = number of participants with data available.
Sodium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.
Outcome measures
| Measure |
LIK066 2.5mg
n=2 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=2 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=2 Participants
LIK066 50mg once daily
|
Placebo
n=2 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=7 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36
Change from BL at Week 12
|
-38.5 millimoles per 24 hours (mmol/24h)
Standard Deviation 86.69
|
45.6 millimoles per 24 hours (mmol/24h)
Standard Deviation 40.52
|
-42.6 millimoles per 24 hours (mmol/24h)
Standard Deviation 28.50
|
82.3 millimoles per 24 hours (mmol/24h)
Standard Deviation 98.29
|
-43.9 millimoles per 24 hours (mmol/24h)
Standard Deviation 112.48
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=3 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=4 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=7 Participants
LIK066 50mg once daily
|
Placebo
n=11 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Left Atrial Size at Weeks 12 and 36
Change from BL at Week 12
|
-1.167 milliliter per square meter (mL/m^2)
Standard Deviation 14.8123
|
0.075 milliliter per square meter (mL/m^2)
Standard Deviation 6.7884
|
2.700 milliliter per square meter (mL/m^2)
Standard Deviation 7.2155
|
-1.045 milliliter per square meter (mL/m^2)
Standard Deviation 11.0223
|
—
|
|
Change From Baseline in Left Atrial Size at Weeks 12 and 36
Change from BL at Week 36
|
16.333 milliliter per square meter (mL/m^2)
Standard Deviation 20.9194
|
—
|
0.300 milliliter per square meter (mL/m^2)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
5.100 milliliter per square meter (mL/m^2)
Standard Deviation 6.2960
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis.Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=5 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=4 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=8 Participants
LIK066 50mg once daily
|
Placebo
n=11 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Left Atrial Volume at Weeks 12 and 36
Change from BL at Week 12
|
12.360 milliliter (mL)
Standard Deviation 42.7067
|
0.225 milliliter (mL)
Standard Deviation 15.4157
|
7.725 milliliter (mL)
Standard Deviation 16.9351
|
-3.591 milliliter (mL)
Standard Deviation 22.8382
|
—
|
|
Change From Baseline in Left Atrial Volume at Weeks 12 and 36
Change from BL at Week 36
|
34.800 milliliter (mL)
Standard Deviation 51.0409
|
—
|
-0.900 milliliter (mL)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
11.333 milliliter (mL)
Standard Deviation 12.7892
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=13 Participants
LIK066 50mg once daily
|
Placebo
n=18 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 12 · Class l
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 12 · Class ll
|
6 Participants
|
6 Participants
|
10 Participants
|
13 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 12 · Class lll
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 12 · Class lV
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 36 · Class l
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 36 · Class ll
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 36 · Class lll
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Week 36 · Class lV
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
The change from BL in NYHA class at a given visit is a three-category ordinal variable (improved/unchanged/worsened) with the following definition: 1. Improved, if NYHA class decreases at least one level from BL; 2. Unchanged, if NYHA class is unchanged from BL; 3. Worsened, if NYHA class increases at least one level from BL. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=9 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=8 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=13 Participants
LIK066 50mg once daily
|
Placebo
n=18 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Week 12 · Improved
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Week 12 · Unchanged
|
8 Participants
|
7 Participants
|
12 Participants
|
13 Participants
|
—
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Week 12 · Worsened
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Week 36 · Improved
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Week 36 · Unchanged
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Week 36 · Worsened
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms are considered per study objective. Due to early termination of the study, only the data shown was available.
Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Outcome measures
| Measure |
LIK066 2.5mg
n=3 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
LIk066 10mg once daily
|
LIK066 50mg
n=1 Participants
LIK066 50mg once daily
|
Placebo
n=3 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36
|
0.7 ratio
Interval 0.4 to 1.4
|
—
|
1.3 ratio
N/A = there is no upper/lower limit for n = 1
|
1.0 ratio
Interval 0.5 to 1.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: Safety Set: All patients who received at least 1 dose of double-blind study drug \& included patients who participated in sub-study. Due to early termination of study, only data shown was available. 'Overall Number of Participants Analyzed' = enrolled in 24h urine collection sub-study. 'Number Analyzed '= number of participants with data available
Urinary calcium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.
Outcome measures
| Measure |
LIK066 2.5mg
n=1 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=1 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=2 Participants
LIK066 50mg once daily
|
Placebo
n=1 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=5 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36
Change from BL at Week 12
|
1.40 millimoles per day (mmol/d)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
3.80 millimoles per day (mmol/d)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
0.10 millimoles per day (mmol/d)
Standard Deviation 0.566
|
0.60 millimoles per day (mmol/d)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
-0.49 millimoles per day (mmol/d)
Standard Deviation 3.202
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Safety Set (SAF), which consisted of all patients who received at least one dose of double-blind study drug, was considered. The analysis included patients who participated in the 24h urine collection sub-study. Due to early termination of the study, only the data shown was available.
Urinary phosphate excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.
Outcome measures
| Measure |
LIK066 2.5mg
n=2 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
n=2 Participants
LIk066 10mg once daily
|
LIK066 50mg
n=2 Participants
LIK066 50mg once daily
|
Placebo
n=1 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=6 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
24 Hour Urinary Phosphate Excretion at Weeks 12 and 36
Change from BL at Week 12
|
55.35 millimoles per day (mmol/d)
Standard Deviation 25.809
|
19.25 millimoles per day (mmol/d)
Standard Deviation 55.225
|
-125.95 millimoles per day (mmol/d)
Standard Deviation 105.571
|
5.30 millimoles per day (mmol/d)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
26.07 millimoles per day (mmol/d)
Standard Deviation 142.536
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36Population: The Safety Set (SAF), which consisted of all patients who received at least one dose of double-blind study drug, was considered. The analysis included participants who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.
To evaluate bone mineral density as assessed by bone mineral content after 12 weeks and after 36 weeks of treatment. Only descriptive statistics were done.
Outcome measures
| Measure |
LIK066 2.5mg
n=1 Participants
LIK066 2.5mg once daily
|
LIK066 10mg
LIk066 10mg once daily
|
LIK066 50mg
n=1 Participants
LIK066 50mg once daily
|
Placebo
n=1 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
Placebo
n=1 Participants
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36
Wk 36 Whole Body - Hd Hologic Chge BL
|
-58.220 grams (g)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
64.620 grams (g)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36
Wk 12 Whole Body - Hd Hologic Chge BL
|
-13.250 grams (g)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
-3.340 grams (g)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
|
Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36
Wk 12 Whole Body - Hd Lunar Chge BL
|
—
|
—
|
-78.750 grams (g)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
37.350 grams (g)
Standard Deviation NA
NA: Not estimable due to insufficient number of participants with events
|
—
|
Adverse Events
LIK066 2.5mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
LIK066 10mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
LIK066 50mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
EMPA 25mg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
LIK066 2.5mg
n=15 participants at risk
LIK066 2.5mg once daily
|
LIK066 10mg
n=16 participants at risk
LIK066 10mg once daily
|
LIK066 50mg
n=30 participants at risk
LIK066 50mg once daily
|
EMPA 25mg
n=30 participants at risk
Empagliflozin 25 mg once daily
|
Placebo
n=33 participants at risk
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Cardiac disorders
Cardiac failure
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
General disorders
Cardiac death
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Diarrhoea infectious
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Nervous system disorders
Cerebral vascular occlusion
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
Other adverse events
| Measure |
LIK066 2.5mg
n=15 participants at risk
LIK066 2.5mg once daily
|
LIK066 10mg
n=16 participants at risk
LIK066 10mg once daily
|
LIK066 50mg
n=30 participants at risk
LIK066 50mg once daily
|
EMPA 25mg
n=30 participants at risk
Empagliflozin 25 mg once daily
|
Placebo
n=33 participants at risk
LIK066 matching placebo and empagliflozin matching placebo
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.7%
2/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.7%
2/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.7%
2/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
General disorders
Thirst
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.1%
2/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.1%
2/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Investigations
Heart rate irregular
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Investigations
Liver function test increased
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.1%
2/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
12.5%
2/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.7%
2/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
10.0%
3/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.1%
2/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Nervous system disorders
Dysaesthesia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.2%
1/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.3%
1/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
0.00%
0/16 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
6.7%
2/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
10.0%
3/30 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
3.0%
1/33 • Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER