Trial Outcomes & Findings for A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity (NCT NCT03320941)
NCT ID: NCT03320941
Last Updated: 2024-06-26
Results Overview
The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2024-06-26
Participant Flow
126 participants were randomized and received at least one dose of study drug.
Participant milestones
| Measure |
LIK066 2.5mg qd
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
LIK066 25 mg qd
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
Placebo
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
28
|
31
|
29
|
|
Overall Study
COMPLETED
|
19
|
19
|
28
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
LIK066 2.5mg qd
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
LIK066 25 mg qd
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
Placebo
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
subject/guardian decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Baseline characteristics by cohort
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 10.44 • n=99 Participants
|
57.2 years
STANDARD_DEVIATION 7.54 • n=107 Participants
|
56.8 years
STANDARD_DEVIATION 9.50 • n=206 Participants
|
57.9 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 9.76 • n=31 Participants
|
57.7 years
STANDARD_DEVIATION 9.83 • n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
48 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
78 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
126 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug
The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Body Weight at Week 12
|
-1.86 Percent Change
Interval -2.59 to -0.67
|
-2.84 Percent Change
Interval -3.79 to -2.16
|
0.11 Percent Change
Interval -0.9 to 0.97
|
-3.41 Percent Change
Interval -3.96 to -2.84
|
-3.80 Percent Change
Interval -4.48 to -3.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug
The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for \>=5% and \>=10% was not calculated due to division by zero
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 3%
|
15.8 Percentage of Participants
|
55.6 Percentage of Participants
|
7.1 Percentage of Participants
|
50.0 Percentage of Participants
|
56.7 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 5%
|
5.3 Percentage of Participants
|
27.8 Percentage of Participants
|
0.0 Percentage of Participants
|
17.9 Percentage of Participants
|
26.7 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 10%
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 3% (Dysglycemic)
|
12.5 Percentage of Participants
|
75.0 Percentage of Participants
|
7.7 Percentage of Participants
|
38.5 Percentage of Participants
|
46.2 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 5% (Dysglycemic)
|
0.0 Percentage of Participants
|
62.5 Percentage of Participants
|
0.0 Percentage of Participants
|
23.1 Percentage of Participants
|
23.1 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 10% (Dysglycemic)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 3% (T2DM)
|
18.2 Percentage of Participants
|
40.0 Percentage of Participants
|
6.7 Percentage of Participants
|
60.0 Percentage of Participants
|
64.7 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 5% (T2DM)
|
9.1 Percentage of Participants
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
13.3 Percentage of Participants
|
29.4 Percentage of Participants
|
|
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
>= 10% (T2DM)
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
0.00 Percentage of Participants
|
5.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
Dysglycemic
|
-1.90 percentage change
Interval -3.17 to -0.37
|
-2.95 percentage change
Interval -3.95 to -2.15
|
0.00 percentage change
Interval -1.25 to 1.19
|
-3.29 percentage change
Interval -4.19 to -2.57
|
-3.47 percentage change
Interval -4.31 to -2.54
|
|
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
T2DM
|
-1.64 percentage change
Interval -2.54 to -0.26
|
-2.66 percentage change
Interval -3.49 to -1.16
|
0.10 percentage change
Interval -1.4 to 1.48
|
-3.42 percentage change
Interval -4.3 to -2.42
|
-4.23 percentage change
Interval -5.63 to -3.27
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Waist circumference will be measured to the nearest 0.1 cm in a standing position, at the end of a normal expiration, using a tape at the level of umbilicus. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
Overall Study
|
-2.47 cm
Interval -4.003 to -0.937
|
-2.63 cm
Interval -4.172 to -1.082
|
-1.37 cm
Interval -2.636 to -0.1
|
-2.65 cm
Interval -3.907 to -1.393
|
-3.11 cm
Interval -4.32 to -1.895
|
|
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
Dysglycemic
|
-2.78 cm
Interval -5.187 to -0.368
|
-4.49 cm
Interval -6.856 to -2.123
|
-0.41 cm
Interval -2.312 to 1.483
|
-2.08 cm
Interval -3.977 to -0.177
|
-2.23 cm
Interval -4.123 to -0.333
|
|
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
T2DM
|
-2.22 cm
Interval -4.156 to -0.283
|
-1.39 cm
Interval -3.418 to 0.631
|
-2.19 cm
Interval -3.859 to -0.52
|
-2.90 cm
Interval -4.557 to -1.244
|
-3.88 cm
Interval -5.416 to -2.34
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
HbA1c will be measured from a blood sample obtained and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
Overall Study
|
-0.285 Percentage
Interval -0.415 to -0.155
|
-0.355 Percentage
Interval -0.488 to -0.223
|
-0.079 Percentage
Interval -0.187 to 0.028
|
-0.366 Percentage
Interval -0.473 to -0.259
|
-0.418 Percentage
Interval -0.521 to -0.314
|
|
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
Dysglycemic
|
-0.139 Percentage
Interval -0.261 to -0.016
|
-0.184 Percentage
Interval -0.306 to -0.062
|
-0.050 Percentage
Interval -0.146 to 0.046
|
-0.196 Percentage
Interval -0.292 to -0.101
|
-0.163 Percentage
Interval -0.259 to -0.067
|
|
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
T2DM
|
-0.405 Percentage
Interval -0.616 to -0.195
|
-0.491 Percentage
Interval -0.708 to -0.275
|
-0.093 Percentage
Interval -0.271 to 0.086
|
-0.502 Percentage
Interval -0.679 to -0.325
|
-0.618 Percentage
Interval -0.784 to -0.452
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake) at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
T2DM
|
-0.606 mmol/L
Interval -1.095 to -0.118
|
-1.111 mmol/L
Interval -1.619 to -0.604
|
-0.079 mmol/L
Interval -0.497 to 0.339
|
-1.145 mmol/L
Interval -1.559 to -0.73
|
-1.377 mmol/L
Interval -1.766 to -0.988
|
|
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
Overall Study
|
-0.334 mmol/L
Interval -0.652 to -0.016
|
-0.665 mmol/L
Interval -0.99 to -0.34
|
-0.160 mmol/L
Interval -0.423 to 0.103
|
-0.747 mmol/L
Interval -1.007 to -0.486
|
-0.986 mmol/L
Interval -1.238 to -0.733
|
|
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
Dysglycemic
|
0.002 mmol/L
Interval -0.322 to 0.326
|
-0.126 mmol/L
Interval -0.453 to 0.2
|
-0.217 mmol/L
Interval -0.471 to 0.038
|
-0.262 mmol/L
Interval -0.515 to -0.008
|
-0.472 mmol/L
Interval -0.728 to -0.217
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
Overall Study
|
-4.90 mmHg
Interval -9.049 to -0.746
|
-5.12 mmHg
Interval -9.403 to -0.834
|
-5.36 mmHg
Interval -8.758 to -1.961
|
-6.36 mmHg
Interval -9.781 to -2.935
|
-6.94 mmHg
Interval -10.233 to -3.655
|
|
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
Dysglycemic
|
-5.79 mmHg
Interval -12.457 to 0.883
|
-7.10 mmHg
Interval -13.825 to -0.369
|
-7.09 mmHg
Interval -12.294 to -1.891
|
-3.58 mmHg
Interval -8.811 to 1.657
|
-4.17 mmHg
Interval -9.399 to 1.051
|
|
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
T2DM
|
-4.16 mmHg
Interval -9.414 to 1.091
|
-2.96 mmHg
Interval -8.5 to 2.588
|
-3.77 mmHg
Interval -8.255 to 0.724
|
-8.63 mmHg
Interval -13.143 to -4.12
|
-9.00 mmHg
Interval -13.182 to -4.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, DBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
Dysglycemic
|
-3.32 mmHg
Interval -8.404 to 1.769
|
-4.40 mmHg
Interval -9.49 to 0.699
|
-4.31 mmHg
Interval -8.257 to -0.357
|
-2.46 mmHg
Interval -6.441 to 1.513
|
-4.25 mmHg
Interval -8.23 to -0.279
|
|
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
Overall Study
|
-3.72 mmHg
Interval -6.803 to -0.627
|
-3.54 mmHg
Interval -6.7 to -0.377
|
-3.12 mmHg
Interval -5.647 to -0.597
|
-4.36 mmHg
Interval -6.892 to -1.818
|
-5.23 mmHg
Interval -7.677 to -2.788
|
|
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
T2DM
|
-4.00 mmHg
Interval -7.943 to -0.059
|
-2.45 mmHg
Interval -6.584 to 1.687
|
-1.93 mmHg
Interval -5.303 to 1.448
|
-5.98 mmHg
Interval -9.352 to -2.607
|
-5.92 mmHg
Interval -9.066 to -2.776
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Fasting lipid profile (Triglycerides (TG)), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
Overall Study
|
1.840 Percentage
Interval -30.956 to 34.636
|
11.057 Percentage
Interval -22.372 to 44.487
|
17.401 Percentage
Interval -9.474 to 44.275
|
43.928 Percentage
Interval 17.118 to 70.737
|
5.307 Percentage
Interval -20.648 to 31.261
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
Dysglycemic
|
-1.153 Percentage
Interval -62.637 to 60.331
|
-1.986 Percentage
Interval -64.104 to 60.132
|
20.962 Percentage
Interval -27.416 to 69.34
|
52.284 Percentage
Interval 3.839 to 100.729
|
14.061 Percentage
Interval -34.625 to 62.746
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
T2DM
|
1.016 Percentage
Interval -36.069 to 38.1
|
23.108 Percentage
Interval -14.937 to 61.153
|
13.806 Percentage
Interval -17.085 to 44.697
|
34.747 Percentage
Interval 3.6 to 65.893
|
-0.057 Percentage
Interval -29.478 to 29.363
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Fasting lipid profile (total cholesterol), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
Overall Study
|
-1.290 Percentage
Interval -6.809 to 4.229
|
-2.983 Percentage
Interval -8.711 to 2.745
|
-2.244 Percentage
Interval -6.8 to 2.312
|
0.884 Percentage
Interval -3.663 to 5.43
|
0.302 Percentage
Interval -4.096 to 4.7
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
Dysglycemic
|
-3.055 Percentage
Interval -12.284 to 6.173
|
-6.017 Percentage
Interval -15.916 to 3.882
|
-3.559 Percentage
Interval -10.94 to 3.822
|
4.273 Percentage
Interval -3.085 to 11.63
|
-1.734 Percentage
Interval -9.0 to 5.532
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
T2DM
|
0.158 Percentage
Interval -6.814 to 7.129
|
-1.367 Percentage
Interval -8.67 to 5.937
|
-0.671 Percentage
Interval -6.635 to 5.294
|
-1.646 Percentage
Interval -7.772 to 4.481
|
1.817 Percentage
Interval -3.857 to 7.491
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Fasting lipid profile (HDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
Overall Study
|
1.499 Percentage
Interval -3.683 to 6.682
|
-2.461 Percentage
Interval -7.79 to 2.868
|
-3.454 Percentage
Interval -7.739 to 0.83
|
-5.253 Percentage
Interval -9.514 to -0.993
|
0.112 Percentage
Interval -4.014 to 4.237
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
Dysglycemic
|
-0.519 Percentage
Interval -9.144 to 8.107
|
0.329 Percentage
Interval -8.368 to 9.027
|
-4.329 Percentage
Interval -11.096 to 2.437
|
-3.279 Percentage
Interval -10.056 to 3.498
|
-0.147 Percentage
Interval -6.917 to 6.622
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
T2DM
|
2.886 Percentage
Interval -3.774 to 9.545
|
-4.696 Percentage
Interval -11.654 to 2.261
|
-2.677 Percentage
Interval -8.484 to 3.13
|
-6.993 Percentage
Interval -12.672 to -1.315
|
0.235 Percentage
Interval -5.133 to 5.604
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Fasting lipid profile (LDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
Overall Study
|
0.757 Percentage
Interval -7.22 to 8.734
|
-2.363 Percentage
Interval -10.702 to 5.975
|
-0.552 Percentage
Interval -7.154 to 6.051
|
0.037 Percentage
Interval -6.524 to 6.598
|
4.726 Percentage
Interval -1.616 to 11.068
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
Dysglycemic
|
-3.065 Percentage
Interval -16.507 to 10.376
|
-4.473 Percentage
Interval -18.904 to 9.958
|
-3.994 Percentage
Interval -14.722 to 6.735
|
2.579 Percentage
Interval -8.102 to 13.259
|
2.128 Percentage
Interval -8.426 to 12.681
|
|
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
T2DM
|
3.727 Percentage
Interval -6.379 to 13.833
|
-1.562 Percentage
Interval -12.127 to 9.004
|
2.942 Percentage
Interval -5.699 to 11.584
|
-1.295 Percentage
Interval -10.099 to 7.51
|
6.803 Percentage
Interval -1.311 to 14.917
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
High sensitivity CRP will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
Overall Study
|
-48.448 Percentage
Interval -193.256 to 96.359
|
69.004 Percentage
Interval -75.849 to 213.858
|
-93.268 Percentage
Interval -202.833 to 16.296
|
-24.207 Percentage
Interval -135.765 to 87.352
|
-55.536 Percentage
Interval -163.215 to 52.144
|
|
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
Dysglycemic
|
16.582 Percentage
Interval -128.374 to 161.538
|
6.593 Percentage
Interval -132.996 to 146.182
|
-6.298 Percentage
Interval -108.747 to 96.151
|
-36.745 Percentage
Interval -140.259 to 66.77
|
-43.562 Percentage
Interval -145.987 to 58.864
|
|
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
T2DM
|
-89.337 Percentage
Interval -336.322 to 157.648
|
113.169 Percentage
Interval -128.46 to 354.798
|
-174.159 Percentage
Interval -362.344 to 14.026
|
-18.143 Percentage
Interval -211.748 to 175.463
|
-71.025 Percentage
Interval -252.712 to 110.662
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Uric acid will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Uric Acid at Week 12
Overall Study
|
-52.6 μmol/L
Interval -72.632 to -32.593
|
-55.2 μmol/L
Interval -75.682 to -34.817
|
12.4 μmol/L
Interval -3.832 to 28.722
|
-58.4 μmol/L
Interval -74.803 to -41.984
|
-62.0 μmol/L
Interval -77.864 to -46.067
|
|
Change From Baseline in Uric Acid at Week 12
Dysglycemic
|
-74.9 μmol/L
Interval -113.538 to -36.208
|
-74.0 μmol/L
Interval -111.662 to -36.43
|
12.0 μmol/L
Interval -17.58 to 41.628
|
-69.1 μmol/L
Interval -99.317 to -38.888
|
-72.9 μmol/L
Interval -103.215 to -42.51
|
|
Change From Baseline in Uric Acid at Week 12
T2DM
|
-34.1 μmol/L
Interval -54.663 to -13.537
|
-39.7 μmol/L
Interval -61.36 to -18.05
|
13.4 μmol/L
Interval -4.2 to 30.954
|
-48.4 μmol/L
Interval -65.97 to -30.84
|
-51.6 μmol/L
Interval -68.27 to -34.98
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Urine albumin will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline on Urine Albumin at Week 12
Overall Study
|
-1.838 x 10^4 mmol/L
Interval -4.665 to 0.99
|
0.008 x 10^4 mmol/L
Interval -2.891 to 2.907
|
-1.282 x 10^4 mmol/L
Interval -3.603 to 1.04
|
-3.902 x 10^4 mmol/L
Interval -6.233 to -1.572
|
-3.099 x 10^4 mmol/L
Interval -5.36 to -0.838
|
|
Change From Baseline on Urine Albumin at Week 12
Dysglycemic
|
-1.941 x 10^4 mmol/L
Interval -3.792 to -0.089
|
2.030 x 10^4 mmol/L
Interval 0.184 to 3.875
|
-3.611 x 10^4 mmol/L
Interval -5.062 to -2.161
|
-2.456 x 10^4 mmol/L
Interval -3.934 to -0.978
|
-3.406 x 10^4 mmol/L
Interval -4.857 to -1.954
|
|
Change From Baseline on Urine Albumin at Week 12
T2DM
|
-3.899 x 10^4 mmol/L
Interval -7.776 to -0.022
|
-1.051 x 10^4 mmol/L
Interval -5.051 to 2.949
|
-0.174 x 10^4 mmol/L
Interval -3.442 to 3.094
|
-3.605 x 10^4 mmol/L
Interval -6.864 to -0.345
|
-2.165 x 10^4 mmol/L
Interval -5.262 to 0.932
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
Urine albumin to creatinine ratio will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
Overall Study
|
-0.849 mg/mmol
Interval -2.602 to 0.903
|
-0.848 mg/mmol
Interval -2.648 to 0.951
|
-1.504 mg/mmol
Interval -2.975 to -0.032
|
-2.552 mg/mmol
Interval -4.021 to -1.083
|
-1.878 mg/mmol
Interval -3.283 to -0.473
|
|
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
Dysglycemic
|
-0.553 mg/mmol
Interval -1.449 to 0.343
|
0.487 mg/mmol
Interval -0.411 to 1.384
|
-1.122 mg/mmol
Interval -1.826 to -0.419
|
-0.771 mg/mmol
Interval -1.481 to -0.061
|
-1.018 mg/mmol
Interval -1.718 to -0.319
|
|
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
T2DM
|
-1.234 mg/mmol
Interval -4.334 to 1.867
|
-1.863 mg/mmol
Interval -5.117 to 1.391
|
-1.839 mg/mmol
Interval -4.612 to 0.934
|
-4.005 mg/mmol
Interval -6.751 to -1.259
|
-2.631 mg/mmol
Interval -5.146 to -0.116
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
VFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
Overall Study
|
-4.139 Percent
Interval -11.464 to 3.185
|
-5.832 Percent
Interval -13.164 to 1.5
|
-3.949 Percent
Interval -9.865 to 1.967
|
-9.185 Percent
Interval -15.209 to -3.161
|
-11.352 Percent
Interval -17.098 to -5.606
|
|
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
Dysglycemic
|
-1.532 Percent
Interval -11.15 to 8.085
|
-6.438 Percent
Interval -15.501 to 2.625
|
-0.390 Percent
Interval -7.673 to 6.893
|
-5.977 Percent
Interval -13.567 to 1.612
|
-7.333 Percent
Interval -14.876 to 0.209
|
|
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
T2DM
|
-6.461 Percent
Interval -17.485 to 4.563
|
-5.934 Percent
Interval -17.568 to 5.699
|
-7.137 Percent
Interval -16.553 to 2.28
|
-12.916 Percent
Interval -22.387 to -3.445
|
-14.728 Percent
Interval -23.368 to -6.087
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126
SFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 Participants
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
Overall Study
|
-6.562 Percentage
Interval -10.835 to -2.29
|
-4.454 Percentage
Interval -8.812 to -0.095
|
-3.477 Percentage
Interval -7.051 to 0.097
|
-7.983 Percentage
Interval -11.479 to -4.488
|
-5.745 Percentage
Interval -9.068 to -2.422
|
|
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
Dysglycemic
|
-7.745 Percentage
Interval -14.32 to -1.169
|
-5.962 Percentage
Interval -12.31 to 0.386
|
-4.328 Percentage
Interval -9.502 to 0.845
|
-7.234 Percentage
Interval -12.449 to -2.018
|
-2.127 Percentage
Interval -7.286 to 3.031
|
|
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
T2DM
|
-5.457 Percentage
Interval -11.198 to 0.284
|
-3.646 Percentage
Interval -9.864 to 2.571
|
-2.821 Percentage
Interval -7.865 to 2.223
|
-8.415 Percentage
Interval -13.227 to -3.602
|
-8.481 Percentage
Interval -12.874 to -4.087
|
SECONDARY outcome
Timeframe: Week 12Population: Safety set (SAF): the SAF includes all participants who received at least one dose of study medication.
Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).
Outcome measures
| Measure |
LIK066 2.5mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 Participants
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
Placebo
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
LIK066 25 mg qd
n=28 Participants
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50 mg qd
n=31 Participants
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
|---|---|---|---|---|---|
|
Pharmacokinetics - Plasma Trough Concentrations of LIK066
|
1.63 ng/mL
Standard Deviation 0.947
|
4.17 ng/mL
Standard Deviation 2.94
|
—
|
12.8 ng/mL
Standard Deviation 8.56
|
26.4 ng/mL
Standard Deviation 21.8
|
Adverse Events
LIK066 2.5mg qd
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LIK066 10mg qd
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
LIK066 25mg qd
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LIK066 50mg qd
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LIK066 2.5mg qd
n=19 participants at risk
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 participants at risk
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
LIK066 25mg qd
n=28 participants at risk
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50mg qd
n=31 participants at risk
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 participants at risk
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.2%
1/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
Other adverse events
| Measure |
LIK066 2.5mg qd
n=19 participants at risk
Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.
|
LIK066 10mg qd
n=19 participants at risk
Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.
|
LIK066 25mg qd
n=28 participants at risk
Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.
|
LIK066 50mg qd
n=31 participants at risk
Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
|
Placebo
n=29 participants at risk
Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
14.3%
4/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
38.7%
12/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.9%
2/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.5%
2/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.6%
1/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Gastritis erosive
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.2%
1/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
7.1%
2/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.4%
1/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
General disorders
Malaise
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Hepatobiliary disorders
Hepatic steatosis
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.4%
1/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.6%
1/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.2%
1/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Cellulitis
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
2/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
15.8%
3/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
17.9%
5/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
12.9%
4/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.4%
1/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Investigations
Protein urine present
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
7.1%
2/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
3.4%
1/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
10.5%
2/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.5%
2/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.9%
2/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Investigations
White blood cells urine positive
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
7.1%
2/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.5%
2/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.9%
2/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
6.9%
2/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
5.3%
1/19 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/28 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/31 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
0.00%
0/29 • Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days)
AE additional description
|
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER