A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03320941

Collaborator

(none)

126

Enrollment

Locations

Arms

7.6

Actual Duration (Months)

5.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: LIK066 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease

Actual Study Start Date :

Dec 7, 2017

Actual Primary Completion Date :

Jul 25, 2018

Actual Study Completion Date :

Jul 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LIK066 2.5 mg Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.	Drug: LIK066 LIK066 will be supplied in different doses as tablets to be taken orally daily.
Experimental: LIK066 10 mg Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.	Drug: LIK066 LIK066 will be supplied in different doses as tablets to be taken orally daily.
Experimental: LIK066 25 mg Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.	Drug: LIK066 LIK066 will be supplied in different doses as tablets to be taken orally daily.
Experimental: LIK066 50 mg Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.	Drug: LIK066 LIK066 will be supplied in different doses as tablets to be taken orally daily.
Placebo Comparator: Placebo Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.	Drug: Placebo Placebo will be supplied as tablets to be taken daily orally.

Outcome Measures

Primary Outcome Measures

Percentage Change From Baseline in Body Weight at Week 12 [Baseline, Week 12]
The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.

Secondary Outcome Measures

Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 [Baseline, Week 12]
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
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) [Baseline, Week 12]
The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level [Baseline, Week 12]
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
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) [Baseline, Week 12]
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
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) [Baseline, Week 12]
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
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) [Baseline, Week 12]
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
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) [Baseline, Week 12]
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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) [Baseline, Week 12]
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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol [Baseline, Week 12]
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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) [Baseline, Week 12]
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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) [Baseline, Week 12]
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
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) [Baseline, Week 12]
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
Change From Baseline in Uric Acid at Week 12 [Baseline, Week 12]
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
Change From Baseline on Urine Albumin at Week 12 [Baseline, Week 12]
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
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 [Baseline, Week 12]
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
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 [Baseline, Week 12]
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
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 [Baseline, Week 12]
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
Pharmacokinetics - Plasma Trough Concentrations of LIK066 [Week 12]
Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
BMI ≥ 25 kg/m^{2 combined with at least two obesity-related comorbidities, or BMI ≥ 35
kg/m}2 at least one obesity-related comorbidity
Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%
Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
Visceral fat area ≥ 100 cm^2
Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study

Exclusion Criteria:

Pregnancy or lactating women
Use of pharmacologically active weight-loss medications
Bariatric surgery
Ketoacidosis, lactic acidosis, hyperosmolar coma
Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
Gastro-intestinal (GI) disorders associated with chronic diarrhea
Congestive heart failure, New York Heart Association (NYHA) class III or IV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Matsudo city	Chiba	Japan	271 0077
2	Novartis Investigative Site	Chikushino-city	Fukuoka	Japan	818-0036
3	Novartis Investigative Site	Fukuoka-city	Fukuoka	Japan	810-0066
4	Novartis Investigative Site	Fukuoka-city	Fukuoka	Japan	819-0006
5	Novartis Investigative Site	Kitakyushu-city	Fukuoka	Japan	807-0857
6	Novartis Investigative Site	Akashi	Hyogo	Japan	674-0081
7	Novartis Investigative Site	Kakogawa-city	Hyogo	Japan	675-0101
8	Novartis Investigative Site	Yokohama-city	Kanagawa	Japan	231-0023
9	Novartis Investigative Site	Kumamoto City	Kumamoto	Japan	860-0863
10	Novartis Investigative Site	Kumamoto-city	Kumamoto	Japan	860-8039
11	Novartis Investigative Site	Kyoto city	Kyoto	Japan	600-8898
12	Novartis Investigative Site	Kyoto-city	Kyoto	Japan	615-8125
13	Novartis Investigative Site	Nagasaki city	Nagasaki	Japan	850 0045
14	Novartis Investigative Site	Higashiosaka-city	Osaka	Japan	577-0802
15	Novartis Investigative Site	Higashiosaka-city	Osaka	Japan	577-0803
16	Novartis Investigative Site	Ageo-city	Saitama	Japan	362-8588
17	Novartis Investigative Site	Kawaguchi-City	Saitama	Japan	332 0021
18	Novartis Investigative Site	Tokorozawa-city	Saitama	Japan	359-0042
19	Novartis Investigative Site	Tokorozawa	Saitama	Japan
20	Novartis Investigative Site	Hachioji-city	Tokyo	Japan	192-0046
21	Novartis Investigative Site	Kiyose-city	Tokyo	Japan	204-0021
22	Novartis Investigative Site	Minato-ku	Tokyo	Japan	108-0075
23	Novartis Investigative Site	Shinagawa-ku	Tokyo	Japan	141-0032
24	Novartis Investigative Site	Toshima-ku	Tokyo	Japan	171-0021

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

More Information

Additional Information:

A Plain Language Trial Summary is available on novartisclinicatrials.com

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03320941

Other Study ID Numbers:

CLIK066B1201

First Posted:

Oct 25, 2017

Last Update Posted:

Jan 5, 2021

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

Additional relevant MeSH terms:

Obesity

Licogliflozin

Study Results

Participant Flow

Recruitment Details	126 participants were randomized and received at least one dose of study drug.
Pre-assignment Detail

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Period Title: Overall Study
STARTED	19	19	28	31	29
COMPLETED	19	19	28	30	29
NOT COMPLETED	0	0	0	1	0

Baseline Characteristics

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo	Total
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.	Total of all reporting groups
Overall Participants	19	19	28	31	29	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.2 (10.44)	57.2 (7.54)	56.8 (9.50)	57.9 (11.37)	59.3 (9.76)	57.7 (9.83)
Sex: Female, Male (Count of Participants)
Female	4 21.1%	7 36.8%	11 39.3%	14 45.2%	12 41.4%	48 38.1%
Male	15 78.9%	12 63.2%	17 60.7%	17 54.8%	17 58.6%	78 61.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	19 100%	19 100%	28 100%	31 100%	29 100%	126 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage Change From Baseline in Body Weight at Week 12
Description	The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Number (95% Confidence Interval) [Percent Change]	-1.86	-2.84	-3.41	-3.80	0.11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.99
	Confidence Interval	(2-Sided) 95% -2.92 to -0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.00
	Confidence Interval	(2-Sided) 95% -4.15 to -1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.54
	Confidence Interval	(2-Sided) 95% -4.54 to -2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.91
	Confidence Interval	(2-Sided) 95% -5.01 to -2.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
>= 3%	15.8 83.2%	55.6 292.6%	50.0 178.6%	56.7 182.9%	7.1 24.5%
>= 5%	5.3 27.9%	27.8 146.3%	17.9 63.9%	26.7 86.1%	0.0 0%
>= 10%	0.0 0%	0.0 0%	0.0 0%	3.3 10.6%	0.0 0%
>= 3% (Dysglycemic)	12.5 65.8%	75.0 394.7%	38.5 137.5%	46.2 149%	7.7 26.6%
>= 5% (Dysglycemic)	0.0 0%	62.5 328.9%	23.1 82.5%	23.1 74.5%	0.0 0%
>= 10% (Dysglycemic)	0.0 0%	0.0 0%	0.0 0%	0.0 0%	0.0 0%
>= 3% (T2DM)	18.2 95.8%	40.0 210.5%	60.0 214.3%	64.7 208.7%	6.7 23.1%
>= 5% (T2DM)	9.1 47.9%	0.00 0%	13.3 47.5%	29.4 94.8%	0.00 0%
>= 10% (T2DM)	0.00 0%	0.00 0%	0.00 0%	5.9 19%	0.00 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.390
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.299
	Confidence Interval	(2-Sided) 95% 0.344 to 15.350
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	15.780
	Confidence Interval	(2-Sided) 95% 2.844 to 87.552
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	12.708
	Confidence Interval	(2-Sided) 95% 2.511 to 64.320
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	16.813
	Confidence Interval	(2-Sided) 95% 3.362 to 84.085
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (Dysglycemic)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.727
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.697
	Confidence Interval	(2-Sided) 95% 0.087 to 33.006
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (Dysglycemic)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	28.260
	Confidence Interval	(2-Sided) 95% 2.066 to 386.473
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (Dysglycemic)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.059
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	10.333
	Confidence Interval	(2-Sided) 95% 0.914 to 116.820
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (Dysglycemic)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.062
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.456
	Confidence Interval	(2-Sided) 95% 0.891 to 100.292
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (T2DM)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.336
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.590
	Confidence Interval	(2-Sided) 95% 0.265 to 48.552
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (T2DM)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.075
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	9.112
	Confidence Interval	(2-Sided) 95% 0.799 to 103.872
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (T2DM)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	29.312
	Confidence Interval	(2-Sided) 95% 2.665 to 322.412
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	>= 3% Percent decrease in body weight (T2DM)
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	37.949
	Confidence Interval	(2-Sided) 95% 3.477 to 414.232
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
Description	The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Dysglycemic	-1.90	-2.95	-3.29	-3.47	0.00
T2DM	-1.64	-2.66	-3.42	-4.23	0.10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-1.84
	Confidence Interval	(2-Sided) 95% -3.56 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.98
	Confidence Interval	(2-Sided) 95% -4.56 to -1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.33
	Confidence Interval	(2-Sided) 95% -4.71 to -1.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.51
	Confidence Interval	(2-Sided) 95% -4.93 to -1.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.96
	Confidence Interval	(2-Sided) 95% -3.12 to -0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.88
	Confidence Interval	(2-Sided) 95% -4.37 to -0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.64
	Confidence Interval	(2-Sided) 95% -5.20 to -1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-4.37
	Confidence Interval	(2-Sided) 95% -5.93 to -2.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-2.47	-2.63	-2.65	-3.11	-1.37
Dysglycemic	-2.78	-4.49	-2.08	-2.23	-0.41
T2DM	-2.22	-1.39	-2.90	-3.88	-2.19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.278
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.10
	Confidence Interval	(2-Sided) 95% -3.104 to 0.900
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.011
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.216
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.26
	Confidence Interval	(2-Sided) 95% -3.265 to 0.747
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.013
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.158
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.28
	Confidence Interval	(2-Sided) 95% -3.069 to 0.504
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.902
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.053
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.74
	Confidence Interval	(2-Sided) 95% -3.401 to 0.022
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.890
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.130
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.36
	Confidence Interval	(2-Sided) 95% -5.444 to 0.717
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.534
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.08
	Confidence Interval	(2-Sided) 95% -7.156 to -0.994
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.534
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.215
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.66
	Confidence Interval	(2-Sided) 95% -4.322 to 0.996
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.325
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.184
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.81
	Confidence Interval	(2-Sided) 95% -4.515 to 0.888
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.346
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.982
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95% -2.611 to 2.552
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.292
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.544
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95% -1.809 to 3.401
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.304
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.552
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95% -3.084 to 1.663
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.188
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.143
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.69
	Confidence Interval	(2-Sided) 95% -3.964 to 0.588
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.139
	Estimation Comments

5. Secondary Outcome

Title	Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-0.285	-0.355	-0.366	-0.418	-0.079
Dysglycemic	-0.139	-0.184	-0.196	-0.163	-0.050
T2DM	-0.405	-0.491	-0.502	-0.618	-0.093

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.206
	Confidence Interval	(2-Sided) 95% -0.376 to -0.035
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0860
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.276
	Confidence Interval	(2-Sided) 95% -0.447 to -0.105
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0863
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.287
	Confidence Interval	(2-Sided) 95% -0.437 to -0.136
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0760
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.338
	Confidence Interval	(2-Sided) 95% -0.486 to -0.190
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0747
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.258
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.089
	Confidence Interval	(2-Sided) 95% -0.245 to 0.067
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0775
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.088
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.134
	Confidence Interval	(2-Sided) 95% -0.290 to 0.021
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0774
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.146
	Confidence Interval	(2-Sided) 95% -0.282 to -0.011
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0673
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.100
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.113
	Confidence Interval	(2-Sided) 95% -0.248 to 0.022
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.0673
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.313
	Confidence Interval	(2-Sided) 95% -0.592 to -0.033
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1399
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.399
	Confidence Interval	(2-Sided) 95% -0.681 to -0.117
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1411
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.409
	Confidence Interval	(2-Sided) 95% -0.660 to -0.159
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1253
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.526
	Confidence Interval	(2-Sided) 95% -0.769 to -0.282
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1217
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-0.334	-0.665	-0.747	-0.986	-0.160
Dysglycemic	0.002	-0.126	-0.262	-0.472	-0.217
T2DM	-0.606	-1.111	-1.145	-1.377	-0.079

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.408
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.174
	Confidence Interval	(2-Sided) 95% -0.589 to 0.241
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2094
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.505
	Confidence Interval	(2-Sided) 95% -0.924 to -0.087
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2115
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.587
	Confidence Interval	(2-Sided) 95% -0.956 to -0.217
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1866
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.826
	Confidence Interval	(2-Sided) 95% -1.188 to -0.463
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1831
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.293
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.218
	Confidence Interval	(2-Sided) 95% -0.194 to 0.631
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2054
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.665
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.090
	Confidence Interval	(2-Sided) 95% -0.325 to 0.506
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2068
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.803
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.045
	Confidence Interval	(2-Sided) 95% -0.405 to 0.315
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1791
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.159
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.256
	Confidence Interval	(2-Sided) 95% -0.615 to 0.103
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.1787
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.110
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.527
	Confidence Interval	(2-Sided) 95% -1.176 to 0.122
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3249
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.032
	Confidence Interval	(2-Sided) 95% -1.691 to -0.373
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.3296
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.065
	Confidence Interval	(2-Sided) 95% -1.654 to -0.476
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2946
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.298
	Confidence Interval	(2-Sided) 95% -1.869 to -0.728
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.2855
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-4.90	-5.12	-6.36	-6.94	-5.36
Dysglycemic	-5.79	-7.10	-3.58	-4.17	-7.09
T2DM	-4.16	-2.96	-8.63	-9.00	-3.77

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.865
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 95% -4.898 to 5.822
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.707
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.931
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 95% -5.235 to 5.716
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.765
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.682
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.00
	Confidence Interval	(2-Sided) 95% -5.817 to 3.820
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.433
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.508
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.58
	Confidence Interval	(2-Sided) 95% -6.312 to 3.142
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.387
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.757
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% -7.138 to 9.749
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.206
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.999
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95% -8.571 to 8.563
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.267
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.342
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.52
	Confidence Interval	(2-Sided) 95% -3.848 to 10.880
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.668
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.430
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.92
	Confidence Interval	(2-Sided) 95% -4.454 to 10.292
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.673
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.909
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95% -7.312 to 6.520
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.461
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.821
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% -6.311 to 7.930
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.563
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.132
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.87
	Confidence Interval	(2-Sided) 95% -11.240 to 1.508
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.190
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.093
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.23
	Confidence Interval	(2-Sided) 95% -11.367 to 0.905
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.070
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-3.72	-3.54	-4.36	-5.23	-3.12
Dysglycemic	-3.32	-4.40	-2.46	-4.25	-4.31
T2DM	-4.00	-2.45	-5.98	-5.92	-1.93

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.769
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95% -4.579 to 3.393
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.013
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.839
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95% -4.462 to 3.630
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.043
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.496
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.23
	Confidence Interval	(2-Sided) 95% -4.811 to 2.345
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.807
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.237
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.11
	Confidence Interval	(2-Sided) 95% -5.622 to 1.402
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.774
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.758
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95% -5.435 to 7.415
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.200
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.978
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95% -6.574 to 6.397
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.230
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.512
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.84
	Confidence Interval	(2-Sided) 95% -3.758 to 7.444
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.790
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.985
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95% -5.552 to 5.657
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.792
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.428
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.07
	Confidence Interval	(2-Sided) 95% -7.268 to 3.121
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.599
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.846
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95% -5.853 to 4.812
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.669
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.095
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.05
	Confidence Interval	(2-Sided) 95% -8.825 to 0.721
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.388
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.089
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.99
	Confidence Interval	(2-Sided) 95% -8.610 to 0.623
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.310
	Estimation Comments

9. Secondary Outcome

Title	Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	1.840	11.057	43.928	5.307	17.401
Dysglycemic	-1.153	-1.986	52.284	14.061	20.962
T2DM	1.016	23.108	34.747	-0.057	13.806

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.470
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.561
	Confidence Interval	(2-Sided) 95% -58.106 to 26.985
	Parameter Dispersion	Type: Standard Error of the Mean Value: 21.4808
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.770
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.343
	Confidence Interval	(2-Sided) 95% -49.187 to 36.501
	Parameter Dispersion	Type: Standard Error of the Mean Value: 21.6316
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.169
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	26.527
	Confidence Interval	(2-Sided) 95% -11.462 to 64.516
	Parameter Dispersion	Type: Standard Error of the Mean Value: 19.1803
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.521
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.094
	Confidence Interval	(2-Sided) 95% -49.345 to 25.157
	Parameter Dispersion	Type: Standard Error of the Mean Value: 18.8076
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.571
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-22.115
	Confidence Interval	(2-Sided) 95% -100.058 to 55.828
	Parameter Dispersion	Type: Standard Error of the Mean Value: 38.7858
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.564
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-22.948
	Confidence Interval	(2-Sided) 95% -102.325 to 56.429
	Parameter Dispersion	Type: Standard Error of the Mean Value: 39.4994
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.359
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.322
	Confidence Interval	(2-Sided) 95% -36.712 to 99.356
	Parameter Dispersion	Type: Standard Error of the Mean Value: 33.8550
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.842
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.901
	Confidence Interval	(2-Sided) 95% -76.093 to 62.290
	Parameter Dispersion	Type: Standard Error of the Mean Value: 34.4309
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.601
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.790
	Confidence Interval	(2-Sided) 95% -61.417 to 35.836
	Parameter Dispersion	Type: Standard Error of the Mean Value: 24.3259
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.705
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.302
	Confidence Interval	(2-Sided) 95% -39.517 to 58.121
	Parameter Dispersion	Type: Standard Error of the Mean Value: 24.4220
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.346
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.940
	Confidence Interval	(2-Sided) 95% -23.126 to 65.007
	Parameter Dispersion	Type: Standard Error of the Mean Value: 22.0444
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.516
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-13.863
	Confidence Interval	(2-Sided) 95% -56.283 to 28.556
	Parameter Dispersion	Type: Standard Error of the Mean Value: 21.2205
	Estimation Comments

10. Secondary Outcome

Title	Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-1.290	-2.983	0.884	0.302	-2.244
Dysglycemic	-3.055	-6.017	4.273	-1.734	-3.559
T2DM	0.158	-1.367	-1.646	1.817	-0.671

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.792
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.955
	Confidence Interval	(2-Sided) 95% -6.185 to 8.095
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.6050
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.843
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.739
	Confidence Interval	(2-Sided) 95% -8.100 to 6.623
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.7167
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.339
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.128
	Confidence Interval	(2-Sided) 95% -3.322 to 9.578
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.2564
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.426
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.546
	Confidence Interval	(2-Sided) 95% -3.764 to 8.856
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.1859
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.932
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.504
	Confidence Interval	(2-Sided) 95% -11.299 to 12.307
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.8734
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.700
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.458
	Confidence Interval	(2-Sided) 95% -15.217 to 10.302
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.3493
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.131
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.832
	Confidence Interval	(2-Sided) 95% -2.406 to 18.070
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.0946
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.727
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.825
	Confidence Interval	(2-Sided) 95% -8.619 to 12.269
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.1970
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.857
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.828
	Confidence Interval	(2-Sided) 95% -8.342 to 9.999
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.5876
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.883
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.696
	Confidence Interval	(2-Sided) 95% -10.126 to 8.734
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.7173
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.821
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.975
	Confidence Interval	(2-Sided) 95% -9.547 to 7.597
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.2883
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.547
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.488
	Confidence Interval	(2-Sided) 95% -5.730 to 10.706
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.1111
	Estimation Comments

11. Secondary Outcome

Title	Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	1.499	-2.461	-5.253	0.112	-3.454
Dysglycemic	-0.519	0.329	-3.279	-0.147	-4.329
T2DM	2.886	-4.696	-6.993	0.235	-2.677

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.148
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.954
	Confidence Interval	(2-Sided) 95% -1.781 to 11.689
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.4006
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.775
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.993
	Confidence Interval	(2-Sided) 95% -5.869 to 7.855
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.4645
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.556
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.799
	Confidence Interval	(2-Sided) 95% -7.826 to 4.229
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.0432
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.238
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.566
	Confidence Interval	(2-Sided) 95% -2.391 to 9.524
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.0079
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.488
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.811
	Confidence Interval	(2-Sided) 95% -7.152 to 14.774
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.4552
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.400
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.659
	Confidence Interval	(2-Sided) 95% -6.363 to 15.680
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.4845
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.826
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.050
	Confidence Interval	(2-Sided) 95% -8.525 to 10.626
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.7651
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.384
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.182
	Confidence Interval	(2-Sided) 95% -5.389 to 13.753
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.7627
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.217
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.563
	Confidence Interval	(2-Sided) 95% -3.360 to 14.486
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.4636
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.659
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.019
	Confidence Interval	(2-Sided) 95% -11.112 to 7.074
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.5491
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.291
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.316
	Confidence Interval	(2-Sided) 95% -12.423 to 3.791
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.0556
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.470
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.913
	Confidence Interval	(2-Sided) 95% -5.090 to 10.916
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.0035
	Estimation Comments

12. Secondary Outcome

Title	Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	0.757	-2.363	0.037	4.726	-0.552
Dysglycemic	-3.065	-4.473	2.579	2.128	-3.994
T2DM	3.727	-1.562	-1.295	6.803	2.942

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.802
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.308
	Confidence Interval	(2-Sided) 95% -9.001 to 11.617
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.2049
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.739
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.812
	Confidence Interval	(2-Sided) 95% -12.567 to 8.943
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.4301
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.901
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.588
	Confidence Interval	(2-Sided) 95% -8.745 to 9.922
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.7125
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.255
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.278
	Confidence Interval	(2-Sided) 95% -3.852 to 14.407
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.6095
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.914
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.928
	Confidence Interval	(2-Sided) 95% -16.271 to 18.127
	Parameter Dispersion	Type: Standard Error of the Mean Value: 8.5585
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.959
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.480
	Confidence Interval	(2-Sided) 95% -19.030 to 18.070
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.2308
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.380
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.572
	Confidence Interval	(2-Sided) 95% -8.343 to 21.487
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.4220
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.419
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.121
	Confidence Interval	(2-Sided) 95% -8.986 to 21.228
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.5174
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.906
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.785
	Confidence Interval	(2-Sided) 95% -12.450 to 14.020
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.6209
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.513
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.504
	Confidence Interval	(2-Sided) 95% -18.195 to 9.187
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.8489
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.499
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.237
	Confidence Interval	(2-Sided) 95% -16.691 to 8.216
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.2300
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.516
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.860
	Confidence Interval	(2-Sided) 95% -7.948 to 15.669
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.9073
	Estimation Comments

13. Secondary Outcome

Title	Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-48.448	69.004	-24.207	-55.536	-93.268
Dysglycemic	16.582	6.593	-36.745	-43.562	-6.298
T2DM	-89.337	113.169	-18.143	-71.025	-174.159

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.625
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	44.820
	Confidence Interval	(2-Sided) 95% -136.644 to 226.284
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.079
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	162.273
	Confidence Interval	(2-Sided) 95% -19.326 to 343.871
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.384
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	69.062
	Confidence Interval	(2-Sided) 95% -87.493 to 225.617
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.627
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	37.733
	Confidence Interval	(2-Sided) 95% -115.580 to 191.045
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.797
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.879
	Confidence Interval	(2-Sided) 95% -155.244 to 201.003
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.882
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.891
	Confidence Interval	(2-Sided) 95% -160.215 to 185.996
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.675
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-30.447
	Confidence Interval	(2-Sided) 95% -175.796 to 114.902
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.607
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-37.264
	Confidence Interval	(2-Sided) 95% -182.099 to 107.571
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.591
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	84.822
	Confidence Interval	(2-Sided) 95% -229.131 to 398.775
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.066
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	287.328
	Confidence Interval	(2-Sided) 95% -19.533 to 594.190
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.252
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	156.017
	Confidence Interval	(2-Sided) 95% -113.963 to 425.997
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.431
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	103.135
	Confidence Interval	(2-Sided) 95% -157.287 to 363.556
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Uric Acid at Week 12
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-52.6	-55.2	-58.4	-62.0	12.4
Dysglycemic	-74.9	-74.0	-69.1	-72.9	12.0
T2DM	-34.1	-39.7	-48.4	-51.6	13.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-65.1
	Confidence Interval	(2-Sided) 95% -90.864 to -39.251
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.03
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-67.7
	Confidence Interval	(2-Sided) 95% -93.848 to -41.542
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.21
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-70.8
	Confidence Interval	(2-Sided) 95% -93.942 to -47.735
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.67
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-74.4
	Confidence Interval	(2-Sided) 95% -97.117 to -51.704
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.47
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-86.9
	Confidence Interval	(2-Sided) 95% -135.780 to -38.013
	Parameter Dispersion	Type: Standard Error of the Mean Value: 24.35
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-86.1
	Confidence Interval	(2-Sided) 95% -134.266 to -37.874
	Parameter Dispersion	Type: Standard Error of the Mean Value: 24.01
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-81.1
	Confidence Interval	(2-Sided) 95% -123.369 to -38.883
	Parameter Dispersion	Type: Standard Error of the Mean Value: 21.04
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-84.9
	Confidence Interval	(2-Sided) 95% -127.104 to -42.669
	Parameter Dispersion	Type: Standard Error of the Mean Value: 21.03
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-47.5
	Confidence Interval	(2-Sided) 95% -74.493 to -20.461
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.52
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-53.1
	Confidence Interval	(2-Sided) 95% -80.914 to -25.251
	Parameter Dispersion	Type: Standard Error of the Mean Value: 13.93
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-61.8
	Confidence Interval	(2-Sided) 95% -86.627 to -36.937
	Parameter Dispersion	Type: Standard Error of the Mean Value: 12.43
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-65.0
	Confidence Interval	(2-Sided) 95% -89.291 to -40.713
	Parameter Dispersion	Type: Standard Error of the Mean Value: 12.15
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline on Urine Albumin at Week 12
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-1.838	0.008	-3.902	-3.099	-1.282
Dysglycemic	-1.941	2.030	-2.456	-3.406	-3.611
T2DM	-3.899	-1.051	-3.605	-2.165	-0.174

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.764
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.556
	Confidence Interval	(2-Sided) 95% -4.210 to 3.098
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.8450
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.493
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.289
	Confidence Interval	(2-Sided) 95% -2.423 to 5.001
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.8741
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.117
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.621
	Confidence Interval	(2-Sided) 95% -5.908 to 0.666
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.6596
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.269
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.818
	Confidence Interval	(2-Sided) 95% -5.056 to 1.421
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.6349
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.159
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.671
	Confidence Interval	(2-Sided) 95% -0.676 to 4.017
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1677
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.641
	Confidence Interval	(2-Sided) 95% 3.294 to 7.988
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1678
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.271
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.155
	Confidence Interval	(2-Sided) 95% -0.929 to 3.239
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0371
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.841
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.206
	Confidence Interval	(2-Sided) 95% -1.842 to 2.253
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0190
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.144
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.725
	Confidence Interval	(2-Sided) 95% -8.758 to 1.309
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.5180
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.736
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.877
	Confidence Interval	(2-Sided) 95% -6.055 to 4.302
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.5906
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.143
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.431
	Confidence Interval	(2-Sided) 95% -8.051 to 1.190
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.3113
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.383
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.991
	Confidence Interval	(2-Sided) 95% -6.521 to 2.538
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.2659
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-0.849	-0.848	-2.552	-1.878	-1.504
Dysglycemic	-0.553	0.487	-0.771	-1.018	-1.122
T2DM	-1.234	-1.863	-4.005	-2.631	-1.839

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.572
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.654
	Confidence Interval	(2-Sided) 95% -1.632 to 2.941
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1543
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.578
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.655
	Confidence Interval	(2-Sided) 95% -1.670 to 2.980
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.1738
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.319
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.048
	Confidence Interval	(2-Sided) 95% -3.124 to 1.028
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0479
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.717
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.374
	Confidence Interval	(2-Sided) 95% -2.416 to 1.667
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.0303
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.317
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.570
	Confidence Interval	(2-Sided) 95% -0.562 to 1.701
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.5630
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.609
	Confidence Interval	(2-Sided) 95% 0.460 to 2.758
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.5716
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.487
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.352
	Confidence Interval	(2-Sided) 95% -0.659 to 1.362
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.5029
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.833
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.104
	Confidence Interval	(2-Sided) 95% -0.884 to 1.092
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.4917
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.771
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.605
	Confidence Interval	(2-Sided) 95% -3.541 to 4.752
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.0730
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.991
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.024
	Confidence Interval	(2-Sided) 95% -4.315 to 4.267
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.1453
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.271
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.166
	Confidence Interval	(2-Sided) 95% -6.064 to 1.732
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.9486
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.676
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.792
	Confidence Interval	(2-Sided) 95% -4.570 to 2.986
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.8889
	Estimation Comments

17. Secondary Outcome

Title	Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-4.139	-5.832	-9.185	-11.352	-3.949
Dysglycemic	-1.532	-6.438	-5.977	-7.333	-0.390
T2DM	-6.461	-5.934	-12.916	-14.728	-7.137

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.968
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.190
	Confidence Interval	(2-Sided) 95% -9.603 to 9.222
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.7535
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.693
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.883
	Confidence Interval	(2-Sided) 95% -11.297 to 7.531
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.7545
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.222
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.236
	Confidence Interval	(2-Sided) 95% -13.676 to 3.203
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.2623
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.078
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.403
	Confidence Interval	(2-Sided) 95% -15.648 to 0.841
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.1637
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.850
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.142
	Confidence Interval	(2-Sided) 95% -13.194 to 10.910
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.0033
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.301
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.048
	Confidence Interval	(2-Sided) 95% -17.676 to 5.580
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.7919
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.293
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.587
	Confidence Interval	(2-Sided) 95% -16.147 to 4.972
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.2598
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.189
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.943
	Confidence Interval	(2-Sided) 95% -17.421 to 3.535
	Parameter Dispersion	Type: Standard Error of the Mean Value: 5.2191
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.926
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.676
	Confidence Interval	(2-Sided) 95% -13.800 to 15.152
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.2441
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.873
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.202
	Confidence Interval	(2-Sided) 95% -13.802 to 16.207
	Parameter Dispersion	Type: Standard Error of the Mean Value: 7.5086
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.391
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.779
	Confidence Interval	(2-Sided) 95% -19.164 to 7.605
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.6977
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.239
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.591
	Confidence Interval	(2-Sided) 95% -20.345 to 5.163
	Parameter Dispersion	Type: Standard Error of the Mean Value: 6.3822
	Estimation Comments

18. Secondary Outcome

Title	Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
Description	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
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd	Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
Measure Participants	19	19	28	31	29
Overall Study	-6.562	-4.454	-7.983	-5.745	-3.477
Dysglycemic	-7.745	-5.962	-7.234	-2.127	-4.328
T2DM	-5.457	-3.646	-8.415	-8.481	-2.821

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.278
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.086
	Confidence Interval	(2-Sided) 95% -8.696 to 2.525
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.8326
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.733
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.977
	Confidence Interval	(2-Sided) 95% -6.639 to 4.686
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.8590
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.075
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.507
	Confidence Interval	(2-Sided) 95% -9.482 to 0.468
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.5118
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Overall Study
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.360
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.268
	Confidence Interval	(2-Sided) 95% -7.152 to 2.616
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.4659
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.416
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.147
	Confidence Interval	(2-Sided) 95% -11.792 to 4.959
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.1699
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.693
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.634
	Confidence Interval	(2-Sided) 95% -9.893 to 6.625
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.1121
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.428
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.906
	Confidence Interval	(2-Sided) 95% -10.207 to 4.396
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.6351
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	Dysglycemic
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.548
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.201
	Confidence Interval	(2-Sided) 95% -5.113 to 9.515
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.6414
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	LIK066 2.5mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.500
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.636
	Confidence Interval	(2-Sided) 95% -10.400 to 5.128
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.8828
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	LIK066 10mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.837
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.826
	Confidence Interval	(2-Sided) 95% -8.805 to 7.154
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.9906
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	LIK066 25 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.113
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.594
	Confidence Interval	(2-Sided) 95% -12.556 to 1.368
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.4818
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	LIK066 50 mg qd, Placebo
	Comments	T2DM
	Type of Statistical Test	Other
	Comments	Dose Finding

Statistical Test of Hypothesis	p-Value	0.096
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.660
	Confidence Interval	(2-Sided) 95% -12.361 to 1.041
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.3512
	Estimation Comments

19. Secondary Outcome

Title	Pharmacokinetics - Plasma Trough Concentrations of LIK066
Description	Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
Safety set (SAF): the SAF includes all participants who received at least one dose of study medication.

Arm/Group Title	LIK066 2.5mg qd	LIK066 10mg qd	LIK066 25 mg qd	LIK066 50 mg qd
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.
Measure Participants	19	19	28	31
Mean (Standard Deviation) [ng/mL]	1.63 (0.947)	4.17 (2.94)	12.8 (8.56)	26.4 (21.8)

Adverse Events

	LIK066 2.5mg qd		LIK066 10mg qd		LIK066 25mg qd		LIK066 50mg qd		Placebo
Time Frame	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)
Adverse Event Reporting Description	AE additional description

Arm/Group Title	LIK066 2.5mg qd		LIK066 10mg qd		LIK066 25mg qd		LIK066 50mg qd		Placebo
Arm/Group Description	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks.		Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks.		Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks.		Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks.		Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Serious Adverse Events
	LIK066 2.5mg qd		LIK066 10mg qd		LIK066 25mg qd		LIK066 50mg qd		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)		0/28 (0%)		1/31 (3.2%)		0/29 (0%)
Hepatobiliary disorders
Cholecystitis acute	0/19 (0%)		0/19 (0%)		0/28 (0%)		1/31 (3.2%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	LIK066 2.5mg qd		LIK066 10mg qd		LIK066 25mg qd		LIK066 50mg qd		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/19 (52.6%)		12/19 (63.2%)		13/28 (46.4%)		20/31 (64.5%)		9/29 (31%)
Ear and labyrinth disorders
Vertigo	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Gastrointestinal disorders
Diarrhoea	0/19 (0%)		0/19 (0%)		4/28 (14.3%)		12/31 (38.7%)		2/29 (6.9%)
Flatulence	0/19 (0%)		0/19 (0%)		0/28 (0%)		2/31 (6.5%)		0/29 (0%)
Gastric polyps	0/19 (0%)		1/19 (5.3%)		1/28 (3.6%)		0/31 (0%)		0/29 (0%)
Gastritis erosive	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		1/31 (3.2%)		0/29 (0%)
Gastrooesophageal reflux disease	1/19 (5.3%)		0/19 (0%)		2/28 (7.1%)		0/31 (0%)		1/29 (3.4%)
Large intestine polyp	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Nausea	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
General disorders
Malaise	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Hepatobiliary disorders
Hepatic steatosis	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		1/29 (3.4%)
Infections and infestations
Asymptomatic bacteriuria	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Bronchitis	1/19 (5.3%)		0/19 (0%)		1/28 (3.6%)		1/31 (3.2%)		0/29 (0%)
Cellulitis	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Conjunctivitis	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Gingivitis	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Nasopharyngitis	2/19 (10.5%)		3/19 (15.8%)		5/28 (17.9%)		4/31 (12.9%)		1/29 (3.4%)
Upper respiratory tract infection	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Injury, poisoning and procedural complications
Post-traumatic neck syndrome	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Investigations
Alanine aminotransferase increased	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Protein urine present	1/19 (5.3%)		0/19 (0%)		2/28 (7.1%)		0/31 (0%)		1/29 (3.4%)
Urine albumin/creatinine ratio increased	0/19 (0%)		2/19 (10.5%)		0/28 (0%)		2/31 (6.5%)		2/29 (6.9%)
White blood cells urine positive	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/19 (0%)		1/19 (5.3%)		2/28 (7.1%)		2/31 (6.5%)		2/29 (6.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Neck pain	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Periarthritis	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Nervous system disorders
Headache	0/19 (0%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		2/29 (6.9%)
Renal and urinary disorders
Haematuria	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Pollakiuria	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Skin and subcutaneous tissue disorders
Eczema	1/19 (5.3%)		0/19 (0%)		0/28 (0%)		0/31 (0%)		0/29 (0%)
Urticaria	0/19 (0%)		1/19 (5.3%)		0/28 (0%)		0/31 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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

Results Point of Contact

Name/Title	Study Director
Organization	Novartis Pharmaceuticals
Phone	8627788300
Email	novartis.email@novartis.com

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03320941

Other Study ID Numbers:

CLIK066B1201

First Posted:

Oct 25, 2017

Last Update Posted:

Jan 5, 2021

Last Verified:

Sep 1, 2019