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A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03100058
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Obesity
Overweight
Interventions Drug: LIK066
Drug: Placebo
Enrollment 460
Recruitment Details Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
Pre-assignment Details Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) LIK066 qd/LIK066 25 mg qd (Epoch 4) LIK066 Bid/LIK066 35 mg qd (Epoch 4) Placebo/LIK066 25 mg qd (Epoch 4) Placebo qd (Epoch 4)
Hide Arm/Group Description LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks LIK066 10mg qd (once daily) dosing frequency for 24 weeks LIK066 50mg qd (once daily) dosing frequency for 24 weeks LIK066 150mg qd (once daily) dosing frequency for 24 weeks LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks LIK066 5mg bid (twice daily) dosing frequency for 24 weeks LIK066 25mg bid (twice daily) dosing frequency for 24 weeks LIK066 50mg bid (twice daily) dosing frequency for 24 weeks Matching placebo tablets for 24 weeks LIK066 qd (once daily) patients who entered Epoch 4 and received LIK066 25 mg qd LIK066 bid patients who entered Epoch 4 and received LIK066 35 mg qd Matching placebo tablets for 24 weeks Placebo patients who entered Epoch 4 and received matching Placebo tablets qd
Period Title: Epoch 3 (24 Weeks of Treatment)
Started 38 38 38 77 38 39 38 76 78 0 0 0 0
Completed 35 31 29 63 36 37 30 60 73 0 0 0 0
Not Completed 3 7 9 14 2 2 8 16 5 0 0 0 0
Reason Not Completed
Adverse Event             0             0             4             8             1             0             3             11             2             0             0             0             0
Withdrawal by Subject             2             4             3             4             1             1             1             4             2             0             0             0             0
Non-compliance with study treatment             0             1             1             0             0             1             1             0             0             0             0             0             0
Lost to Follow-up             0             1             1             0             0             0             1             0             1             0             0             0             0
Physician Decision             0             0             0             1             0             0             0             1             0             0             0             0             0
Protocol Violation             0             0             0             1             0             0             1             0             0             0             0             0             0
Death             0             1             0             0             0             0             0             0             0             0             0             0             0
Pregnancy             1             0             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             0             0             0             0             0             0             1             0             0             0             0             0             0
Period Title: Epoch 4 (Last 24 Weeks of the Study)
Started 0 0 0 0 0 0 0 0 0 158 163 39 34
Completed 0 0 0 0 0 0 0 0 0 153 148 36 30
Not Completed 0 0 0 0 0 0 0 0 0 5 15 3 4
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             4             2             1
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             3             1             0
Adverse Event             0             0             0             0             0             0             0             0             0             4             7             0             2
Death             0             0             0             0             0             0             0             0             0             0             1             0             0
Pregnancy             0             0             0             0             0             0             0             0             0             0             0             0             1
non-compliance with study treatment             0             0             0             0             0             0             0             0             0             1             0             0             0
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) Total
Hide Arm/Group Description LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks LIK066 10mg qd (once daily) dosing frequency for 24 weeks LIK066 50mg qd (once daily) dosing frequency for 24 weeks LIK066 150mg qd (once daily) dosing frequency for 24 weeks LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks LIK066 5mg bid (twice daily) dosing frequency for 24 weeks LIK066 25mg bid (twice daily) dosing frequency for 24 weeks LIK066 50mg bid (twice daily) dosing frequency for 24 weeks Matching placebo tablets for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 38 38 38 77 38 39 38 76 78 460
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 38 participants 38 participants 77 participants 38 participants 39 participants 38 participants 76 participants 78 participants 460 participants
51.3  (12.20) 53.2  (10.08) 52.9  (13.60) 51.1  (12.94) 53.4  (12.28) 49.8  (11.50) 49.7  (11.93) 52.9  (11.87) 51.1  (13.27) 51.7  (12.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 38 participants 77 participants 38 participants 39 participants 38 participants 76 participants 78 participants 460 participants
Female
23
  60.5%
27
  71.1%
25
  65.8%
44
  57.1%
20
  52.6%
24
  61.5%
26
  68.4%
49
  64.5%
45
  57.7%
283
  61.5%
Male
15
  39.5%
11
  28.9%
13
  34.2%
33
  42.9%
18
  47.4%
15
  38.5%
12
  31.6%
27
  35.5%
33
  42.3%
177
  38.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 38 participants 77 participants 38 participants 39 participants 38 participants 76 participants 78 participants 460 participants
American Indian or Alaska Native
2
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.6%
2
   2.6%
6
   1.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.6%
0
   0.0%
2
   5.1%
0
   0.0%
5
   6.6%
1
   1.3%
10
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
3
   0.7%
Black or African American
5
  13.2%
4
  10.5%
5
  13.2%
5
   6.5%
2
   5.3%
3
   7.7%
4
  10.5%
6
   7.9%
8
  10.3%
42
   9.1%
White
30
  78.9%
33
  86.8%
33
  86.8%
67
  87.0%
36
  94.7%
32
  82.1%
34
  89.5%
63
  82.9%
64
  82.1%
392
  85.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.6%
1
   2.6%
0
   0.0%
1
   1.3%
0
   0.0%
2
   5.1%
0
   0.0%
0
   0.0%
2
   2.6%
7
   1.5%
1.Primary Outcome
Title Percent Change From Baseline in Body Weight at 24 Weeks
Hide Description Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Time Frame Baseline, Week 24 (Epoch 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78
Mean (95% Confidence Interval)
Unit of Measure: Percent change
-1.24
(-2.50 to -0.45)
-2.04
(-3.36 to -0.88)
-3.52
(-4.62 to -1.87)
-4.37
(-5.36 to -3.37)
-1.67
(-2.61 to -0.27)
-2.51
(-3.94 to -1.32)
-4.06
(-5.52 to -2.87)
-4.47
(-5.49 to -3.48)
-0.63
(-1.56 to 0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-3.17 to -0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.93
Confidence Interval (2-Sided) 95%
-3.36 to -0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.30
Confidence Interval (2-Sided) 95%
-4.86 to -1.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.42
Confidence Interval (2-Sided) 95%
-5.39 to -3.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.14
Confidence Interval (2-Sided) 95%
-2.53 to -0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.74
Confidence Interval (2-Sided) 95%
-4.11 to -1.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.11
Confidence Interval (2-Sided) 95%
-5.54 to -2.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.48
Confidence Interval (2-Sided) 95%
-5.54 to -3.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
Hide Description Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Overall Number of Participants Analyzed 38 38 38 77 38 39 37 75 78
Measure Type: Number
Unit of Measure: Percentage
>=5% 26.3 15.8 34.2 42.9 15.8 20.5 37.8 45.3 12.8
>=10% 5.3 5.3 5.3 6.5 5.3 2.6 10.8 9.3 3.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.38
Confidence Interval (2-Sided) 95%
0.85 to 6.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.779
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.36 to 3.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.69
Confidence Interval (2-Sided) 95%
1.35 to 10.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.57
Confidence Interval (2-Sided) 95%
2.41 to 12.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.812
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.36 to 3.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
0.66 to 5.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.29
Confidence Interval (2-Sided) 95%
1.61 to 11.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.37
Confidence Interval (2-Sided) 95%
2.72 to 14.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.943
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.10 to 12.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.465
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval (2-Sided) 95%
0.28 to 15.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.696
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
0.15 to 17.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.14
Confidence Interval (2-Sided) 95%
0.38 to 12.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.976
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.09 to 11.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.986
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.09 to 11.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.51
Confidence Interval (2-Sided) 95%
0.56 to 22.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=10%
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
0.77 to 20.54
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Hide Description Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Overall Number of Participants Analyzed 38 38 38 77 38 39 37 75 78
Measure Type: Number
Unit of Measure: Percentage
Dysglycemic (>=5%) Number Analyzed 16 participants 16 participants 15 participants 31 participants 15 participants 16 participants 15 participants 31 participants 31 participants
31.3 25.0 40.0 48.4 6.7 37.5 40.0 41.9 9.7
Normoglycemic (>=5%) Number Analyzed 9 participants 9 participants 9 participants 19 participants 9 participants 9 participants 9 participants 17 participants 20 participants
44.4 11.1 44.4 47.4 11.1 11.1 55.6 52.9 20.0
Type 2 Diabetes Mellitus (T2DM) (>=5%) Number Analyzed 13 participants 13 participants 14 participants 27 participants 14 participants 14 participants 13 participants 27 participants 27 participants
7.7 15.4 28.6 37.0 28.6 14.3 30.8 44.4 14.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.29
Confidence Interval (2-Sided) 95%
1.02 to 38.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dsyglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.171
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 3.94
Confidence Interval (2-Sided) 95%
0.55 to 28.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.17
Confidence Interval (2-Sided) 95%
1.09 to 47.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.89
Confidence Interval (2-Sided) 95%
2.32 to 60.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.976
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.08 to 11.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.78
Confidence Interval (2-Sided) 95%
1.37 to 56.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.50
Confidence Interval (2-Sided) 95%
1.20 to 46.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Dysglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.28
Confidence Interval (2-Sided) 95%
2.11 to 60.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.21
Confidence Interval (2-Sided) 95%
0.48 to 21.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.763
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.06 to 7.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.68
Confidence Interval (2-Sided) 95%
0.76 to 28.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.33
Confidence Interval (2-Sided) 95%
1.14 to 24.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.788
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.06 to 8.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.751
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.06 to 7.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.05
Confidence Interval (2-Sided) 95%
1.27 to 51.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (Normoglycemic)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.64
Confidence Interval (2-Sided) 95%
1.30 to 34.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.528
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.05 to 4.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.958
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.17 to 6.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.546
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
0.30 to 9.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding test
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.09
Confidence Interval (2-Sided) 95%
0.81 to 11.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.563
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
0.31 to 8.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.610
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.06 to 5.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.528
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
0.32 to 9.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments >=5% (T2DM)
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.55
Confidence Interval (2-Sided) 95%
1.23 to 16.90
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage Change From Baseline on Waist Circumference
Hide Description Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.
Time Frame Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78 158 163 39 34
Mean (95% Confidence Interval)
Unit of Measure: Percentage Change
-2.1
(-3.87 to -0.31)
-2.7
(-4.55 to -0.92)
-3.7
(-5.55 to -1.82)
-5.6
(-6.84 to -4.35)
-2.7
(-4.47 to -0.91)
-4.3
(-6.07 to -2.57)
-4.8
(-6.61 to -2.98)
-4.6
(-5.89 to -3.31)
-1.3
(-2.54 to -0.05)
-0.4
(-1.25 to 0.36)
-0.7
(-1.53 to 0.10)
-2.1
(-3.73 to -0.38)
0.4
(-1.37 to 2.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.470
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.96 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.199
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.64 to 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.64 to 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.206
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-3.56 to 0.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-5.18 to -0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-5.70 to -1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-5.10 to -1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 qd/LIK066 25mg qd (Epoch 4), Placebo/Placebo (Epoch 4)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.391
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.82 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LIK066 Bid/LIK066 35mg qd (Epoch 4), Placebo/Placebo (Epoch 4)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.259
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-3.10 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo/LIK066 25mg qd (Epoch 4), Placebo/Placebo (Epoch 4)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-4.91 to -0.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)
Hide Description FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).
Time Frame Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78 158 163 39 34
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
1.9
(0.55 to 3.19)
-0.1
(-1.46 to 1.27)
-1.2
(-2.60 to 0.26)
-0.8
(-1.70 to 0.16)
-0.5
(-1.80 to 0.86)
-1.1
(-2.37 to 0.27)
-0.9
(-2.28 to 0.46)
-1.0
(-1.96 to -0.13)
0.9
(-0.06 to 1.81)
-0.1
(-0.64 to 0.35)
-0.3
(-0.79 to 0.22)
-0.1
(-1.14 to 0.84)
0.6
(-0.54 to 1.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.225
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.62 to 2.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.62 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.75 to -0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.96 to -0.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.106
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-2.97 to 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.54 to -0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.44 to -0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.22 to -0.61
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)
Hide Description HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.
Time Frame Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78 158 163 39 34
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
0.1
(-0.23 to 0.45)
-0.5
(-0.82 to -0.13)
-0.9
(-1.24 to -0.50)
-0.7
(-0.92 to -0.44)
-0.3
(-0.68 to 0.00)
-0.5
(-0.83 to -0.15)
-0.6
(-0.98 to -0.28)
-0.6
(-0.87 to -0.40)
-0.3
(-0.50 to -0.02)
0.2
(0.03 to 0.38)
0.0
(-0.13 to 0.22)
-0.1
(-0.49 to 0.24)
0.3
(-0.07 to 0.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.05 to 0.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.63 to 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.05 to -0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.76 to -0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.707
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.50 to 0.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.65 to 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.80 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.72 to -0.04
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Hide Description At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured
Time Frame Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78 158 163 39 34
Mean (95% Confidence Interval)
Unit of Measure: mmHg
systolic blood pressure (SBP) Number Analyzed 38 participants 38 participants 38 participants 77 participants 38 participants 39 participants 37 participants 75 participants 78 participants 58 participants 162 participants 37 participants 34 participants
-1.2
(-4.38 to 1.93)
-1.5
(-4.38 to 1.93)
-4.9
(-8.30 to -1.52)
-1.2
(-3.38 to 1.06)
-0.7
(-3.86 to 2.43)
0.8
(-2.38 to 3.88)
-2.6
(-5.82 to 0.69)
-1.8
(-4.15 to 0.48)
1.6
(-0.67 to 3.80)
-0.9
(-2.66 to 0.79)
-1.6
(-3.39 to 0.10)
-5.6
(-9.22 to -2.06)
0.8
(-2.97 to 4.65)
diastolic blood pressure (DBP) Number Analyzed 38 participants 38 participants 38 participants 77 participants 38 participants 39 participants 37 participants 75 participants 78 participants 158 participants 162 participants 37 participants 34 participants
-0.2
(-2.37 to 2.00)
0.1
(-2.21 to 2.40)
-2.3
(-4.62 to 0.07)
-1.3
(-2.82 to 0.26)
0.8
(-1.35 to 3.02)
-1.4
(-3.57 to 0.78)
0.3
(-1.99 to 2.54)
-1.7
(-3.26 to -0.06)
0.5
(-1.03 to 2.08)
-0.6
(-1.69 to 0.56)
-1.2
(-2.30 to -0.04)
-2.0
(-4.33 to 0.34)
0.6
(-1.89 to 3.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-6.64 to 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-7.11 to 0.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.5
Confidence Interval (2-Sided) 95%
-10.52 to -2.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-5.86 to 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.245
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-6.12 to 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.678
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-4.65 to 3.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-8.07 to -0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments SBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-6.61 to -0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg qd (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.601
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-3.38 to 1.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection LIK066 10mg qd (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.760
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-3.20 to 2.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection LIK066 50mg qd (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-5.60 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection LIK066 150mg qd (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-3.98 to 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection LIK066 2.5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.820
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-2.36 to 2.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection LIK066 5mg Bid (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-4.58 to 0.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection LIK066 25mg Bid (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.859
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-2.99 to 2.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection LIK066 50mg Bid (Epoch 3), Placebo (Epoch 3)
Comments DBP
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-4.41 to 0.04
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in 24-hour Urinary Glucose Excretion
Hide Description Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.
Time Frame Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3) LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78 158 163 39 34
Mean (95% Confidence Interval)
Unit of Measure: mmol/24hr
208.6
(101.85 to 315.40)
134.6
(-8.69 to 277.85)
377.0
(206.19 to 547.90)
306.1
(199.59 to 412.62)
183.0
(32.37 to 333.70)
193.8
(82.22 to 305.31)
241.3
(135.13 to 347.30)
308.9
(198.27 to 419.53)
-17.8
(-94.20 to 58.61)
26.8
(-30.03 to 83.70)
122.5
(69.82 to 175.26)
248.0
(137.72 to 358.33)
-148.9
(-269.62 to -28.10)
9.Secondary Outcome
Title Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
Hide Description Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Time Frame Between Week 24 and Week 48 (Epoch 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 158 163 39 34
Mean (95% Confidence Interval)
Unit of Measure: Percentage
-0.2
(-0.70 to 0.33)
-0.2
(-0.68 to 0.35)
-2.4
(-3.47 to -1.33)
0.4
(-0.74 to 1.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LIK066 qd/LIK066 25mg qd (Epoch 4), Placebo/Placebo (Epoch 4)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.355
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.84 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LIK066 Bid/LIK066 35mg qd (Epoch 4), Placebo/Placebo (Epoch 4)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.83 to 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo/LIK066 25mg qd (Epoch 4), Placebo/Placebo (Epoch 4)
Comments [Not Specified]
Type of Statistical Test Other
Comments Dose finding study
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-4.36 to -1.24
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Hide Description Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Time Frame Baseline, Week 24
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Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78
Mean (Standard Deviation)
Unit of Measure: mmol/24hr
Baseline Number Analyzed 12 participants 9 participants 9 participants 16 participants 9 participants 13 participants 38 participants 20 participants 26 participants
49.6  (25.08) 33.1  (29.65) 40.2  (21.55) 34.6  (17.56) 44.7  (26.83) 43.6  (16.91) 38.0  (22.13) 47.9  (23.64) 43.0  (22.63)
Week 24 (Timepoint 1) Number Analyzed 38 participants 38 participants 38 participants 77 participants 5 participants 12 participants 8 participants 15 participants 23 participants
48.8  (26.59) 38.1  (32.20) 39.8  (22.48) 40.1  (18.20) 52.4  (32.78) 45.9  (15.41) 38.0  (22.13) 48.1  (21.93) 44.7  (23.0)
Week 24 (Timepoint 2) Number Analyzed 10 participants 7 participants 7 participants 8 participants 5 participants 12 participants 8 participants 15 participants 23 participants
54.2  (29.34) 42.0  (29.99) 39.2  (20.24) 62.8  (34.26) 51.2  (35.32) 54.6  (23.77) 37.9  (32.33) 53.0  (26.95) 52.2  (30.75)
Week 24 (Timepoint 3) Number Analyzed 38 participants 38 participants 38 participants 77 participants 38 participants 39 participants 38 participants 15 participants 23 participants
5.4  (22.74) 3.9  (19.56) -0.6  (12.07) 22.8  (28.42) -1.2  (7.77) 8.7  (18.21) -0.1  (14.39) 4.9  (26.20) 7.5  (32.91)
11.Secondary Outcome
Title Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Hide Description Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Time Frame Baseline, Week 24, Week 48
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Full Analysis Set
Arm/Group Title LIK066 qd/LIK066 25mg qd (Epoch 4) LIK066 Bid/LIK066 35mg qd (Epoch 4) Placebo/LIK066 25mg qd (Epoch 4) Placebo/Placebo (Epoch 4)
Hide Arm/Group Description:
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Overall Number of Participants Analyzed 158 163 39 34
Mean (Standard Deviation)
Unit of Measure: mmol/24hr
Baseline Number Analyzed 33 participants 40 participants 11 participants 13 participants
4.8  (3.02) 5.0  (2.84) 4.6  (0.91) 5.6  (4.07)
Week 48(Timepoint 1) Number Analyzed 26 participants 33 participants 10 participants 9 participants
5.1  (307) 5.2  (2.95) 4.5  (0.95) 6.6  (4.55)
Week 48(Timepoint 2) Number Analyzed 26 participants 33 participants 10 participants 9 participants
4.6  (2.33) 5.6  (4.55) 5.4  (3.65) 4.8  (2.10)
Week 48(Timepoint 3) Number Analyzed 26 participants 33 participants 10 participants 9 participants
-0.5  (3.41) 0.4  (2.81) 0.9  (4.10) -1.8  (3.26)
12.Secondary Outcome
Title Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Hide Description Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Time Frame Week 24, Week 48
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Full Analysis Set
Arm/Group Title LIK066 2.5mg qd (Epoch 3) LIK066 10mg qd (Epoch 3) LIK066 50mg qd (Epoch 3) LIK066 150mg qd (Epoch 3) LIK066 2.5mg Bid (Epoch 3) LIK066 5mg Bid (Epoch 3) LIK066 25mg Bid (Epoch 3) LIK066 50mg Bid (Epoch 3) Placebo (Epoch 3)
Hide Arm/Group Description:
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Matching placebo tablets for 24 weeks
Overall Number of Participants Analyzed 38 38 38 77 38 39 38 76 78
Mean (Standard Deviation)
Unit of Measure: mmol/24hr
Baseline Number Analyzed 12 participants 10 participants 10 participants 16 participants 9 participants 14 participants 9 participants 21 participants 26 participants
282.1  (128.10) 240.5  (74.64) 254.5  (105.70) 291.5  (175.10) 284.0  (117.60) 241.8  (82.75) 277.0  (99.67) 293.7  (120.70) 297.0  (145.10)
Week 24 (Timepoint 1) Number Analyzed 10 participants 7 participants 8 participants 10 participants