Obesity
Conditions
Keywords
Obesity disease, Over weight, T2DM, interventional study, Weight loss
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.
Interventions
DRUGLIK066
LIK066 will be supplied in different doses as tablets to be taken orally daily.
DRUGPlacebo
Placebo will be supplied as tablets to be taken daily orally.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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). |
| 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 |
Countries
Japan
Participant flow
Recruitment details
126 participants were randomized and received at least one dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| LIK066 2.5mg qd Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily (qd) for 12 weeks. | 19 |
| LIK066 10mg qd Eligible patients randomized to this arm will receive LIK066 10 mg orally daily (qd) for 12 weeks. | 19 |
| LIK066 25 mg qd Eligible patients randomized to this arm will receive LIK066 25 mg orally daily (qd) for 12 weeks. | 28 |
| LIK066 50 mg qd Eligible patients randomized to this arm will receive LIK066 50 mg orally daily (qd) for 12 weeks. | 31 |
| Placebo Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks. | 29 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | subject/guardian decision | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | LIK066 2.5mg qd | Total | Placebo | LIK066 50 mg qd | LIK066 25 mg qd | LIK066 10mg qd |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 10.44 | 57.7 years STANDARD_DEVIATION 9.83 | 59.3 years STANDARD_DEVIATION 9.76 | 57.9 years STANDARD_DEVIATION 11.37 | 56.8 years STANDARD_DEVIATION 9.5 | 57.2 years STANDARD_DEVIATION 7.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 126 Participants | 29 Participants | 31 Participants | 28 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 48 Participants | 12 Participants | 14 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 78 Participants | 17 Participants | 17 Participants | 17 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 28 | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 10 / 19 | 12 / 19 | 13 / 28 | 20 / 31 | 9 / 29 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 28 | 1 / 31 | 0 / 29 |
Outcome results
Primary
Percentage Change From Baseline in Body Weight at 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.
Time frame: Baseline, Week 12
Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline in Body Weight at Week 12 | -1.86 Percent Change |
| LIK066 10mg qd | Percentage Change From Baseline in Body Weight at Week 12 | -2.84 Percent Change |
| LIK066 25 mg qd | Percentage Change From Baseline in Body Weight at Week 12 | -3.41 Percent Change |
| LIK066 50 mg qd | Percentage Change From Baseline in Body Weight at Week 12 | -3.80 Percent Change |
| Placebo | Percentage Change From Baseline in Body Weight at Week 12 | 0.11 Percent Change |
95% CI: [-2.92, -0.21]
95% CI: [-4.15, -1.7]
95% CI: [-4.54, -2.26]
95% CI: [-5.01, -2.77]
Secondary
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Overall Study | -3.72 mmHg |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | T2DM | -4.00 mmHg |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Dysglycemic | -3.32 mmHg |
| LIK066 10mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Dysglycemic | -4.40 mmHg |
| LIK066 10mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Overall Study | -3.54 mmHg |
| LIK066 10mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | T2DM | -2.45 mmHg |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Dysglycemic | -2.46 mmHg |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Overall Study | -4.36 mmHg |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | T2DM | -5.98 mmHg |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Overall Study | -5.23 mmHg |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | T2DM | -5.92 mmHg |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Dysglycemic | -4.25 mmHg |
| Placebo | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Dysglycemic | -4.31 mmHg |
| Placebo | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | Overall Study | -3.12 mmHg |
| Placebo | Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) | T2DM | -1.93 mmHg |
Comparison: Dysglycemicp-value: 0.75895% CI: [-5.435, 7.415]ANCOVA
Comparison: Overall Studyp-value: 0.76995% CI: [-4.579, 3.393]ANCOVA
Comparison: Overall Studyp-value: 0.83995% CI: [-4.462, 3.63]ANCOVA
Comparison: Overall Studyp-value: 0.49695% CI: [-4.811, 2.345]ANCOVA
Comparison: Overall Studyp-value: 0.23795% CI: [-5.622, 1.402]ANCOVA
Comparison: Dysglycemicp-value: 0.97895% CI: [-6.574, 6.397]ANCOVA
Comparison: Dysglycemicp-value: 0.51295% CI: [-3.758, 7.444]ANCOVA
Comparison: Dysglycemicp-value: 0.98595% CI: [-5.552, 5.657]ANCOVA
Comparison: T2DMp-value: 0.42895% CI: [-7.268, 3.121]ANCOVA
Comparison: T2DMp-value: 0.84695% CI: [-5.853, 4.812]ANCOVA
Comparison: T2DMp-value: 0.09595% CI: [-8.825, 0.721]ANCOVA
Comparison: T2DMp-value: 0.08995% CI: [-8.61, 0.623]ANCOVA
Secondary
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Overall Study | -0.334 mmol/L |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | T2DM | -0.606 mmol/L |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Dysglycemic | 0.002 mmol/L |
| LIK066 10mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Dysglycemic | -0.126 mmol/L |
| LIK066 10mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Overall Study | -0.665 mmol/L |
| LIK066 10mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | T2DM | -1.111 mmol/L |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Dysglycemic | -0.262 mmol/L |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Overall Study | -0.747 mmol/L |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | T2DM | -1.145 mmol/L |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Overall Study | -0.986 mmol/L |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | T2DM | -1.377 mmol/L |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Dysglycemic | -0.472 mmol/L |
| Placebo | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Dysglycemic | -0.217 mmol/L |
| Placebo | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | Overall Study | -0.160 mmol/L |
| Placebo | Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) | T2DM | -0.079 mmol/L |
Comparison: Overall Studyp-value: 0.40895% CI: [-0.589, 0.241]ANCOVA
Comparison: Overall Studyp-value: 0.01895% CI: [-0.924, -0.087]ANCOVA
Comparison: Overall Studyp-value: 0.00295% CI: [-0.956, -0.217]ANCOVA
Comparison: Overall Studyp-value: <0.00195% CI: [-1.188, -0.463]ANCOVA
Comparison: Dysglycemicp-value: 0.29395% CI: [-0.194, 0.631]ANCOVA
Comparison: Dysglycemicp-value: 0.66595% CI: [-0.325, 0.506]ANCOVA
Comparison: Dysglycemicp-value: 0.80395% CI: [-0.405, 0.315]ANCOVA
Comparison: Dysglycemicp-value: 0.15995% CI: [-0.615, 0.103]ANCOVA
Comparison: T2DMp-value: 0.1195% CI: [-1.176, 0.122]ANCOVA
Comparison: T2DMp-value: 0.00395% CI: [-1.691, -0.373]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-1.654, -0.476]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-1.869, -0.728]ANCOVA
Secondary
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Overall Study | -4.90 mmHg |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | T2DM | -4.16 mmHg |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Dysglycemic | -5.79 mmHg |
| LIK066 10mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Dysglycemic | -7.10 mmHg |
| LIK066 10mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Overall Study | -5.12 mmHg |
| LIK066 10mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | T2DM | -2.96 mmHg |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Dysglycemic | -3.58 mmHg |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Overall Study | -6.36 mmHg |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | T2DM | -8.63 mmHg |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Overall Study | -6.94 mmHg |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | T2DM | -9.00 mmHg |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Dysglycemic | -4.17 mmHg |
| Placebo | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Dysglycemic | -7.09 mmHg |
| Placebo | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | Overall Study | -5.36 mmHg |
| Placebo | Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) | T2DM | -3.77 mmHg |
Comparison: Overall Studyp-value: 0.86595% CI: [-4.898, 5.822]ANCOVA
Comparison: Overall Studyp-value: 0.93195% CI: [-5.235, 5.716]ANCOVA
Comparison: Overall Studyp-value: 0.68295% CI: [-5.817, 3.82]ANCOVA
Comparison: Overall Studyp-value: 0.50895% CI: [-6.312, 3.142]ANCOVA
Comparison: Dysglycemicp-value: 0.75795% CI: [-7.138, 9.749]ANCOVA
Comparison: Dysglycemicp-value: 0.99995% CI: [-8.571, 8.563]ANCOVA
Comparison: Dysglycemicp-value: 0.34295% CI: [-3.848, 10.88]ANCOVA
Comparison: Dysglycemicp-value: 0.4395% CI: [-4.454, 10.292]ANCOVA
Comparison: T2DMp-value: 0.90995% CI: [-7.312, 6.52]ANCOVA
Comparison: T2DMp-value: 0.82195% CI: [-6.311, 7.93]ANCOVA
Comparison: T2DMp-value: 0.13295% CI: [-11.24, 1.508]ANCOVA
Comparison: T2DMp-value: 0.09395% CI: [-11.367, 0.905]ANCOVA
Secondary
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Overall Study | -2.47 cm |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | T2DM | -2.22 cm |
| LIK066 2.5mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Dysglycemic | -2.78 cm |
| LIK066 10mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Dysglycemic | -4.49 cm |
| LIK066 10mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Overall Study | -2.63 cm |
| LIK066 10mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | T2DM | -1.39 cm |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Dysglycemic | -2.08 cm |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Overall Study | -2.65 cm |
| LIK066 25 mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | T2DM | -2.90 cm |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Overall Study | -3.11 cm |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | T2DM | -3.88 cm |
| LIK066 50 mg qd | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Dysglycemic | -2.23 cm |
| Placebo | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Dysglycemic | -0.41 cm |
| Placebo | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | Overall Study | -1.37 cm |
| Placebo | Change From Baseline at Week 12 on Waist Circumference at Umbilical Level | T2DM | -2.19 cm |
Comparison: Overall Studyp-value: 0.27895% CI: [-3.104, 0.9]ANCOVA
Comparison: Overall Studyp-value: 0.21695% CI: [-3.265, 0.747]ANCOVA
Comparison: Overall Studyp-value: 0.15895% CI: [-3.069, 0.504]ANCOVA
Comparison: Overall Studyp-value: 0.05395% CI: [-3.401, 0.022]ANCOVA
Comparison: Dysglycemicp-value: 0.1395% CI: [-5.444, 0.717]ANCOVA
Comparison: Dysglycemicp-value: 0.01195% CI: [-7.156, -0.994]ANCOVA
Comparison: Dysglycemicp-value: 0.21595% CI: [-4.322, 0.996]ANCOVA
Comparison: Dysglycemicp-value: 0.18495% CI: [-4.515, 0.888]ANCOVA
Comparison: T2DMp-value: 0.98295% CI: [-2.611, 2.552]ANCOVA
Comparison: T2DMp-value: 0.54495% CI: [-1.809, 3.401]ANCOVA
Comparison: T2DMp-value: 0.55295% CI: [-3.084, 1.663]ANCOVA
Comparison: T2DMp-value: 0.14395% CI: [-3.964, 0.588]ANCOVA
Secondary
Change From Baseline in Uric Acid at 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
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline in Uric Acid at Week 12 | Overall Study | -52.6 μmol/L |
| LIK066 2.5mg qd | Change From Baseline in Uric Acid at Week 12 | Dysglycemic | -74.9 μmol/L |
| LIK066 2.5mg qd | Change From Baseline in Uric Acid at Week 12 | T2DM | -34.1 μmol/L |
| LIK066 10mg qd | Change From Baseline in Uric Acid at Week 12 | Dysglycemic | -74.0 μmol/L |
| LIK066 10mg qd | Change From Baseline in Uric Acid at Week 12 | Overall Study | -55.2 μmol/L |
| LIK066 10mg qd | Change From Baseline in Uric Acid at Week 12 | T2DM | -39.7 μmol/L |
| LIK066 25 mg qd | Change From Baseline in Uric Acid at Week 12 | T2DM | -48.4 μmol/L |
| LIK066 25 mg qd | Change From Baseline in Uric Acid at Week 12 | Dysglycemic | -69.1 μmol/L |
| LIK066 25 mg qd | Change From Baseline in Uric Acid at Week 12 | Overall Study | -58.4 μmol/L |
| LIK066 50 mg qd | Change From Baseline in Uric Acid at Week 12 | T2DM | -51.6 μmol/L |
| LIK066 50 mg qd | Change From Baseline in Uric Acid at Week 12 | Dysglycemic | -72.9 μmol/L |
| LIK066 50 mg qd | Change From Baseline in Uric Acid at Week 12 | Overall Study | -62.0 μmol/L |
| Placebo | Change From Baseline in Uric Acid at Week 12 | T2DM | 13.4 μmol/L |
| Placebo | Change From Baseline in Uric Acid at Week 12 | Dysglycemic | 12.0 μmol/L |
| Placebo | Change From Baseline in Uric Acid at Week 12 | Overall Study | 12.4 μmol/L |
Comparison: Overall Studyp-value: <0.00195% CI: [-90.864, -39.251]ANCOVA
Comparison: Overall Studyp-value: <0.00195% CI: [-93.848, -41.542]ANCOVA
Comparison: Overall Studyp-value: <0.00195% CI: [-93.942, -47.735]ANCOVA
Comparison: Overall Studyp-value: <0.00195% CI: [-97.117, -51.704]ANCOVA
Comparison: Dysglycemicp-value: <0.00195% CI: [-135.78, -38.013]ANCOVA
Comparison: Dysglycemicp-value: <0.00195% CI: [-134.266, -37.874]ANCOVA
Comparison: Dysglycemicp-value: <0.00195% CI: [-123.369, -38.883]ANCOVA
Comparison: Dysglycemicp-value: <0.00195% CI: [-127.104, -42.669]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-74.493, -20.461]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-80.914, -25.251]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-86.627, -36.937]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-89.291, -40.713]ANCOVA
Secondary
Change From Baseline on Urine Albumin at 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
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline on Urine Albumin at Week 12 | Overall Study | -1.838 x 10^4 mmol/L |
| LIK066 2.5mg qd | Change From Baseline on Urine Albumin at Week 12 | T2DM | -3.899 x 10^4 mmol/L |
| LIK066 2.5mg qd | Change From Baseline on Urine Albumin at Week 12 | Dysglycemic | -1.941 x 10^4 mmol/L |
| LIK066 10mg qd | Change From Baseline on Urine Albumin at Week 12 | Dysglycemic | 2.030 x 10^4 mmol/L |
| LIK066 10mg qd | Change From Baseline on Urine Albumin at Week 12 | Overall Study | 0.008 x 10^4 mmol/L |
| LIK066 10mg qd | Change From Baseline on Urine Albumin at Week 12 | T2DM | -1.051 x 10^4 mmol/L |
| LIK066 25 mg qd | Change From Baseline on Urine Albumin at Week 12 | Dysglycemic | -2.456 x 10^4 mmol/L |
| LIK066 25 mg qd | Change From Baseline on Urine Albumin at Week 12 | Overall Study | -3.902 x 10^4 mmol/L |
| LIK066 25 mg qd | Change From Baseline on Urine Albumin at Week 12 | T2DM | -3.605 x 10^4 mmol/L |
| LIK066 50 mg qd | Change From Baseline on Urine Albumin at Week 12 | Overall Study | -3.099 x 10^4 mmol/L |
| LIK066 50 mg qd | Change From Baseline on Urine Albumin at Week 12 | T2DM | -2.165 x 10^4 mmol/L |
| LIK066 50 mg qd | Change From Baseline on Urine Albumin at Week 12 | Dysglycemic | -3.406 x 10^4 mmol/L |
| Placebo | Change From Baseline on Urine Albumin at Week 12 | Dysglycemic | -3.611 x 10^4 mmol/L |
| Placebo | Change From Baseline on Urine Albumin at Week 12 | Overall Study | -1.282 x 10^4 mmol/L |
| Placebo | Change From Baseline on Urine Albumin at Week 12 | T2DM | -0.174 x 10^4 mmol/L |
Comparison: Overall Studyp-value: 0.76495% CI: [-4.21, 3.098]ANCOVA
Comparison: Overall Studyp-value: 0.49395% CI: [-2.423, 5.001]ANCOVA
Comparison: Overall Studyp-value: 0.11795% CI: [-5.908, 0.666]ANCOVA
Comparison: Overall Studyp-value: 0.26995% CI: [-5.056, 1.421]ANCOVA
Comparison: Dysglycemicp-value: 0.15995% CI: [-0.676, 4.017]ANCOVA
Comparison: Dysglycemicp-value: <0.00195% CI: [3.294, 7.988]ANCOVA
Comparison: Dysglycemicp-value: 0.27195% CI: [-0.929, 3.239]ANCOVA
Comparison: Dysglycemicp-value: 0.84195% CI: [-1.842, 2.253]ANCOVA
Comparison: T2DMp-value: 0.14495% CI: [-8.758, 1.309]ANCOVA
Comparison: T2DMp-value: 0.73695% CI: [-6.055, 4.302]ANCOVA
Comparison: T2DMp-value: 0.14395% CI: [-8.051, 1.19]ANCOVA
Comparison: T2DMp-value: 0.38395% CI: [-6.521, 2.538]ANCOVA
Secondary
Change From Baseline on Urine Albumin to Creatinine Ratio at 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
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Overall Study | -0.849 mg/mmol |
| LIK066 2.5mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | T2DM | -1.234 mg/mmol |
| LIK066 2.5mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Dysglycemic | -0.553 mg/mmol |
| LIK066 10mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Dysglycemic | 0.487 mg/mmol |
| LIK066 10mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Overall Study | -0.848 mg/mmol |
| LIK066 10mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | T2DM | -1.863 mg/mmol |
| LIK066 25 mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Dysglycemic | -0.771 mg/mmol |
| LIK066 25 mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Overall Study | -2.552 mg/mmol |
| LIK066 25 mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | T2DM | -4.005 mg/mmol |
| LIK066 50 mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Overall Study | -1.878 mg/mmol |
| LIK066 50 mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | T2DM | -2.631 mg/mmol |
| LIK066 50 mg qd | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Dysglycemic | -1.018 mg/mmol |
| Placebo | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Dysglycemic | -1.122 mg/mmol |
| Placebo | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | Overall Study | -1.504 mg/mmol |
| Placebo | Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 | T2DM | -1.839 mg/mmol |
Comparison: Overall Studyp-value: 0.57295% CI: [-1.632, 2.941]ANCOVA
Comparison: Overall Studyp-value: 0.57895% CI: [-1.67, 2.98]ANCOVA
Comparison: Overall Studyp-value: 0.31995% CI: [-3.124, 1.028]ANCOVA
Comparison: Overall Studyp-value: 0.71795% CI: [-2.416, 1.667]ANCOVA
Comparison: Dysglycemicp-value: 0.31795% CI: [-0.562, 1.701]ANCOVA
Comparison: Dysglycemicp-value: 0.00795% CI: [0.46, 2.758]ANCOVA
Comparison: Dysglycemicp-value: 0.48795% CI: [-0.659, 1.362]ANCOVA
Comparison: Dysglycemicp-value: 0.83395% CI: [-0.884, 1.092]ANCOVA
Comparison: T2DMp-value: 0.77195% CI: [-3.541, 4.752]ANCOVA
Comparison: T2DMp-value: 0.99195% CI: [-4.315, 4.267]ANCOVA
Comparison: T2DMp-value: 0.27195% CI: [-6.064, 1.732]ANCOVA
Comparison: T2DMp-value: 0.67695% CI: [-4.57, 2.986]ANCOVA
Secondary
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Overall Study | 1.499 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | T2DM | 2.886 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Dysglycemic | -0.519 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Dysglycemic | 0.329 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Overall Study | -2.461 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | T2DM | -4.696 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Dysglycemic | -3.279 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Overall Study | -5.253 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | T2DM | -6.993 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Overall Study | 0.112 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | T2DM | 0.235 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Dysglycemic | -0.147 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Dysglycemic | -4.329 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | Overall Study | -3.454 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) | T2DM | -2.677 Percentage |
Comparison: Overall Studyp-value: 0.14895% CI: [-1.781, 11.689]ANCOVA
Comparison: Overall Studyp-value: 0.77595% CI: [-5.869, 7.855]ANCOVA
Comparison: Overall Studyp-value: 0.55695% CI: [-7.826, 4.229]ANCOVA
Comparison: Overall Studyp-value: 0.23895% CI: [-2.391, 9.524]ANCOVA
Comparison: Dysglycemicp-value: 0.48895% CI: [-7.152, 14.774]ANCOVA
Comparison: Dysglycemicp-value: 0.495% CI: [-6.363, 15.68]ANCOVA
Comparison: Dysglycemicp-value: 0.82695% CI: [-8.525, 10.626]ANCOVA
Comparison: Dysglycemicp-value: 0.38495% CI: [-5.389, 13.753]ANCOVA
Comparison: T2DMp-value: 0.21795% CI: [-3.36, 14.486]ANCOVA
Comparison: T2DMp-value: 0.65995% CI: [-11.112, 7.074]ANCOVA
Comparison: T2DMp-value: 0.29195% CI: [-12.423, 3.791]ANCOVA
Comparison: T2DMp-value: 0.4795% CI: [-5.09, 10.916]ANCOVA
Secondary
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Overall Study | 0.757 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | T2DM | 3.727 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Dysglycemic | -3.065 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Dysglycemic | -4.473 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Overall Study | -2.363 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | T2DM | -1.562 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Dysglycemic | 2.579 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Overall Study | 0.037 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | T2DM | -1.295 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Overall Study | 4.726 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | T2DM | 6.803 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Dysglycemic | 2.128 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Dysglycemic | -3.994 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | Overall Study | -0.552 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) | T2DM | 2.942 Percentage |
Comparison: Overall Studyp-value: 0.80295% CI: [-9.001, 11.617]ANCOVA
Comparison: Overall Studyp-value: 0.73995% CI: [-12.567, 8.943]ANCOVA
Comparison: Overall Studyp-value: 0.90195% CI: [-8.745, 9.922]ANCOVA
Comparison: Overall Studyp-value: 0.25595% CI: [-3.852, 14.407]ANCOVA
Comparison: Dysglycemicp-value: 0.91495% CI: [-16.271, 18.127]ANCOVA
Comparison: Dysglycemicp-value: 0.95995% CI: [-19.03, 18.07]ANCOVA
Comparison: Dysglycemicp-value: 0.3895% CI: [-8.343, 21.487]ANCOVA
Comparison: Dysglycemicp-value: 0.41995% CI: [-8.986, 21.228]ANCOVA
Comparison: T2DMp-value: 0.90695% CI: [-12.45, 14.02]ANCOVA
Comparison: T2DMp-value: 0.51395% CI: [-18.195, 9.187]ANCOVA
Comparison: T2DMp-value: 0.49995% CI: [-16.691, 8.216]ANCOVA
Comparison: T2DMp-value: 0.51695% CI: [-7.948, 15.669]ANCOVA
Secondary
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Overall Study | -1.290 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | T2DM | 0.158 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Dysglycemic | -3.055 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Dysglycemic | -6.017 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Overall Study | -2.983 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | T2DM | -1.367 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Dysglycemic | 4.273 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Overall Study | 0.884 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | T2DM | -1.646 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Overall Study | 0.302 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | T2DM | 1.817 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Dysglycemic | -1.734 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Dysglycemic | -3.559 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | Overall Study | -2.244 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol | T2DM | -0.671 Percentage |
Comparison: Overall Studyp-value: 0.79295% CI: [-6.185, 8.095]ANCOVA
Comparison: Overall Studyp-value: 0.84395% CI: [-8.1, 6.623]ANCOVA
Comparison: Overall Studyp-value: 0.33995% CI: [-3.322, 9.578]ANCOVA
Comparison: Overall Studyp-value: 0.42695% CI: [-3.764, 8.856]ANCOVA
Comparison: Dysglycemicp-value: 0.93295% CI: [-11.299, 12.307]ANCOVA
Comparison: Dysglycemicp-value: 0.795% CI: [-15.217, 10.302]ANCOVA
Comparison: Dysglycemicp-value: 0.13195% CI: [-2.406, 18.07]ANCOVA
Comparison: Dysglycemicp-value: 0.72795% CI: [-8.619, 12.269]ANCOVA
Comparison: T2DMp-value: 0.85795% CI: [-8.342, 9.999]ANCOVA
Comparison: T2DMp-value: 0.88395% CI: [-10.126, 8.734]ANCOVA
Comparison: T2DMp-value: 0.82195% CI: [-9.547, 7.597]ANCOVA
Comparison: T2DMp-value: 0.54795% CI: [-5.73, 10.706]ANCOVA
Secondary
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Overall Study | 1.840 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | T2DM | 1.016 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Dysglycemic | -1.153 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Dysglycemic | -1.986 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Overall Study | 11.057 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | T2DM | 23.108 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Dysglycemic | 52.284 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Overall Study | 43.928 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | T2DM | 34.747 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Overall Study | 5.307 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | T2DM | -0.057 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Dysglycemic | 14.061 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Dysglycemic | 20.962 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | Overall Study | 17.401 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) | T2DM | 13.806 Percentage |
Comparison: Overall Studyp-value: 0.4795% CI: [-58.106, 26.985]ANCOVA
Comparison: Overall Studyp-value: 0.7795% CI: [-49.187, 36.501]ANCOVA
Comparison: Overall Studyp-value: 0.16995% CI: [-11.462, 64.516]ANCOVA
Comparison: Overall Studyp-value: 0.52195% CI: [-49.345, 25.157]ANCOVA
Comparison: Dysglycemicp-value: 0.57195% CI: [-100.058, 55.828]ANCOVA
Comparison: Dysglycemicp-value: 0.56495% CI: [-102.325, 56.429]ANCOVA
Comparison: Dysglycemicp-value: 0.35995% CI: [-36.712, 99.356]ANCOVA
Comparison: Dysglycemicp-value: 0.84295% CI: [-76.093, 62.29]ANCOVA
Comparison: T2DMp-value: 0.60195% CI: [-61.417, 35.836]ANCOVA
Comparison: T2DMp-value: 0.70595% CI: [-39.517, 58.121]ANCOVA
Comparison: T2DMp-value: 0.34695% CI: [-23.126, 65.007]ANCOVA
Comparison: T2DMp-value: 0.51695% CI: [-56.283, 28.556]ANCOVA
Secondary
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Overall Study | -0.285 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | T2DM | -0.405 Percentage |
| LIK066 2.5mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Dysglycemic | -0.139 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Dysglycemic | -0.184 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Overall Study | -0.355 Percentage |
| LIK066 10mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | T2DM | -0.491 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Dysglycemic | -0.196 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Overall Study | -0.366 Percentage |
| LIK066 25 mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | T2DM | -0.502 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Overall Study | -0.418 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | T2DM | -0.618 Percentage |
| LIK066 50 mg qd | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Dysglycemic | -0.163 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Dysglycemic | -0.050 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | Overall Study | -0.079 Percentage |
| Placebo | Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) | T2DM | -0.093 Percentage |
Comparison: Overall Studyp-value: 0.01895% CI: [-0.376, -0.035]ANCOVA
Comparison: Overall Studyp-value: 0.00295% CI: [-0.447, -0.105]ANCOVA
Comparison: Overall Studyp-value: <0.00195% CI: [-0.437, -0.136]ANCOVA
Comparison: Overall Studyp-value: <0.00195% CI: [-0.486, -0.19]ANCOVA
Comparison: Dysglycemicp-value: 0.25895% CI: [-0.245, 0.067]ANCOVA
Comparison: Dysglycemicp-value: 0.08895% CI: [-0.29, 0.021]ANCOVA
Comparison: Dysglycemicp-value: 0.03595% CI: [-0.282, -0.011]ANCOVA
Comparison: Dysglycemicp-value: 0.195% CI: [-0.248, 0.022]ANCOVA
Comparison: T2DMp-value: 0.02995% CI: [-0.592, -0.033]ANCOVA
Comparison: T2DMp-value: 0.00695% CI: [-0.681, -0.117]ANCOVA
Comparison: T2DMp-value: 0.00295% CI: [-0.66, -0.159]ANCOVA
Comparison: T2DMp-value: <0.00195% CI: [-0.769, -0.282]ANCOVA
Secondary
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LIK066 2.5mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Dysglycemic | -1.90 percentage change |
| LIK066 2.5mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | T2DM | -1.64 percentage change |
| LIK066 10mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Dysglycemic | -2.95 percentage change |
| LIK066 10mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | T2DM | -2.66 percentage change |
| LIK066 25 mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Dysglycemic | -3.29 percentage change |
| LIK066 25 mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | T2DM | -3.42 percentage change |
| LIK066 50 mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | T2DM | -4.23 percentage change |
| LIK066 50 mg qd | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Dysglycemic | -3.47 percentage change |
| Placebo | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | Dysglycemic | 0.00 percentage change |
| Placebo | Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) | T2DM | 0.10 percentage change |
Comparison: Dysglycemic95% CI: [-3.56, -0.19]
Comparison: Dysglycemic95% CI: [-4.56, -1.46]
Comparison: Dysglycemic95% CI: [-4.71, -1.82]
Comparison: Dysglycemic95% CI: [-4.93, -1.74]
Comparison: T2DM95% CI: [-3.12, -0.15]
Comparison: T2DM95% CI: [-4.37, -0.61]
Comparison: T2DM95% CI: [-5.2, -1.52]
Comparison: T2DM95% CI: [-5.93, -2.79]
Secondary
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Overall Study | -48.448 Percentage |
| LIK066 2.5mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | T2DM | -89.337 Percentage |
| LIK066 2.5mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Dysglycemic | 16.582 Percentage |
| LIK066 10mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Dysglycemic | 6.593 Percentage |
| LIK066 10mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Overall Study | 69.004 Percentage |
| LIK066 10mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | T2DM | 113.169 Percentage |
| LIK066 25 mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Dysglycemic | -36.745 Percentage |
| LIK066 25 mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Overall Study | -24.207 Percentage |
| LIK066 25 mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | T2DM | -18.143 Percentage |
| LIK066 50 mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Overall Study | -55.536 Percentage |
| LIK066 50 mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | T2DM | -71.025 Percentage |
| LIK066 50 mg qd | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Dysglycemic | -43.562 Percentage |
| Placebo | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Dysglycemic | -6.298 Percentage |
| Placebo | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | Overall Study | -93.268 Percentage |
| Placebo | Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) | T2DM | -174.159 Percentage |
Comparison: Overall Studyp-value: 0.62595% CI: [-136.644, 226.284]ANCOVA
Comparison: Overall Studyp-value: 0.07995% CI: [-19.326, 343.871]ANCOVA
Comparison: Overall Studyp-value: 0.38495% CI: [-87.493, 225.617]ANCOVA
Comparison: Overall Studyp-value: 0.62795% CI: [-115.58, 191.045]ANCOVA
Comparison: Dysglycemicp-value: 0.79795% CI: [-155.244, 201.003]ANCOVA
Comparison: Dysglycemicp-value: 0.88295% CI: [-160.215, 185.996]ANCOVA
Comparison: Dysglycemicp-value: 0.67595% CI: [-175.796, 114.902]ANCOVA
Comparison: Dysglycemicp-value: 0.60795% CI: [-182.099, 107.571]ANCOVA
Comparison: T2DMp-value: 0.59195% CI: [-229.131, 398.775]ANCOVA
Comparison: T2DMp-value: 0.06695% CI: [-19.533, 594.19]ANCOVA
Comparison: T2DMp-value: 0.25295% CI: [-113.963, 425.997]ANCOVA
Comparison: T2DMp-value: 0.43195% CI: [-157.287, 363.556]ANCOVA
Secondary
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at 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
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Overall Study | -6.562 Percentage |
| LIK066 2.5mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | T2DM | -5.457 Percentage |
| LIK066 2.5mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Dysglycemic | -7.745 Percentage |
| LIK066 10mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Dysglycemic | -5.962 Percentage |
| LIK066 10mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Overall Study | -4.454 Percentage |
| LIK066 10mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | T2DM | -3.646 Percentage |
| LIK066 25 mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Dysglycemic | -7.234 Percentage |
| LIK066 25 mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Overall Study | -7.983 Percentage |
| LIK066 25 mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | T2DM | -8.415 Percentage |
| LIK066 50 mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Overall Study | -5.745 Percentage |
| LIK066 50 mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | T2DM | -8.481 Percentage |
| LIK066 50 mg qd | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Dysglycemic | -2.127 Percentage |
| Placebo | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Dysglycemic | -4.328 Percentage |
| Placebo | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | Overall Study | -3.477 Percentage |
| Placebo | Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 | T2DM | -2.821 Percentage |
Comparison: Overall Studyp-value: 0.27895% CI: [-8.696, 2.525]ANCOVA
Comparison: Overall Studyp-value: 0.73395% CI: [-6.639, 4.686]ANCOVA
Comparison: Overall Studyp-value: 0.07595% CI: [-9.482, 0.468]ANCOVA
Comparison: Overall Studyp-value: 0.3695% CI: [-7.152, 2.616]ANCOVA
Comparison: Dysglycemicp-value: 0.41695% CI: [-11.792, 4.959]ANCOVA
Comparison: Dysglycemicp-value: 0.69395% CI: [-9.893, 6.625]ANCOVA
Comparison: Dysglycemicp-value: 0.42895% CI: [-10.207, 4.396]ANCOVA
Comparison: Dysglycemicp-value: 0.54895% CI: [-5.113, 9.515]ANCOVA
Comparison: T2DMp-value: 0.595% CI: [-10.4, 5.128]ANCOVA
Comparison: T2DMp-value: 0.83795% CI: [-8.805, 7.154]ANCOVA
Comparison: T2DMp-value: 0.11395% CI: [-12.556, 1.368]ANCOVA
Comparison: T2DMp-value: 0.09695% CI: [-12.361, 1.041]ANCOVA
Secondary
Percent Change From Baseline on Visceral Fat Area (VFA) at 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
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Overall Study | -4.139 Percent |
| LIK066 2.5mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | T2DM | -6.461 Percent |
| LIK066 2.5mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Dysglycemic | -1.532 Percent |
| LIK066 10mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Dysglycemic | -6.438 Percent |
| LIK066 10mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Overall Study | -5.832 Percent |
| LIK066 10mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | T2DM | -5.934 Percent |
| LIK066 25 mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Dysglycemic | -5.977 Percent |
| LIK066 25 mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Overall Study | -9.185 Percent |
| LIK066 25 mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | T2DM | -12.916 Percent |
| LIK066 50 mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Overall Study | -11.352 Percent |
| LIK066 50 mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | T2DM | -14.728 Percent |
| LIK066 50 mg qd | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Dysglycemic | -7.333 Percent |
| Placebo | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Dysglycemic | -0.390 Percent |
| Placebo | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | Overall Study | -3.949 Percent |
| Placebo | Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 | T2DM | -7.137 Percent |
Comparison: T2DMp-value: 0.39195% CI: [-19.164, 7.605]ANCOVA
Comparison: Overall Studyp-value: 0.96895% CI: [-9.603, 9.222]ANCOVA
Comparison: Overall Studyp-value: 0.69395% CI: [-11.297, 7.531]ANCOVA
Comparison: Overall Studyp-value: 0.22295% CI: [-13.676, 3.203]ANCOVA
Comparison: Overall Studyp-value: 0.07895% CI: [-15.648, 0.841]ANCOVA
Comparison: Dysglycemicp-value: 0.8595% CI: [-13.194, 10.91]ANCOVA
Comparison: Dysglycemicp-value: 0.30195% CI: [-17.676, 5.58]ANCOVA
Comparison: Dysglycemicp-value: 0.29395% CI: [-16.147, 4.972]ANCOVA
Comparison: Dysglycemicp-value: 0.18995% CI: [-17.421, 3.535]ANCOVA
Comparison: T2DMp-value: 0.92695% CI: [-13.8, 15.152]ANCOVA
Comparison: T2DMp-value: 0.87395% CI: [-13.802, 16.207]ANCOVA
Comparison: T2DMp-value: 0.23995% CI: [-20.345, 5.163]ANCOVA
Secondary
Pharmacokinetics - Plasma Trough Concentrations of LIK066
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
Population: Safety set (SAF): the SAF includes all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIK066 2.5mg qd | Pharmacokinetics - Plasma Trough Concentrations of LIK066 | 1.63 ng/mL | Standard Deviation 0.947 |
| LIK066 10mg qd | Pharmacokinetics - Plasma Trough Concentrations of LIK066 | 4.17 ng/mL | Standard Deviation 2.94 |
| LIK066 25 mg qd | Pharmacokinetics - Plasma Trough Concentrations of LIK066 | 12.8 ng/mL | Standard Deviation 8.56 |
| LIK066 50 mg qd | Pharmacokinetics - Plasma Trough Concentrations of LIK066 | 26.4 ng/mL | Standard Deviation 21.8 |
Secondary
Responder Rates According to Percentage Decrease in Body Weight From Baseline to 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
Time frame: Baseline, Week 12
Population: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (T2DM) | 0.00 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (Dysglycemic) | 0.0 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% | 5.3 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (Dysglycemic) | 0.0 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (T2DM) | 9.1 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% | 0.0 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (T2DM) | 18.2 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (Dysglycemic) | 12.5 Percentage of Participants |
| LIK066 2.5mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% | 15.8 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (T2DM) | 40.0 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (Dysglycemic) | 0.0 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (Dysglycemic) | 75.0 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (Dysglycemic) | 62.5 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% | 0.0 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (T2DM) | 0.00 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% | 27.8 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% | 55.6 Percentage of Participants |
| LIK066 10mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (T2DM) | 0.00 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (Dysglycemic) | 0.0 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% | 50.0 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% | 17.9 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% | 0.0 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (Dysglycemic) | 38.5 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (Dysglycemic) | 23.1 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (T2DM) | 60.0 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (T2DM) | 13.3 Percentage of Participants |
| LIK066 25 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (T2DM) | 0.00 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (Dysglycemic) | 46.2 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (Dysglycemic) | 0.0 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% | 3.3 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (T2DM) | 64.7 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% | 26.7 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (T2DM) | 5.9 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (T2DM) | 29.4 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% | 56.7 Percentage of Participants |
| LIK066 50 mg qd | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (Dysglycemic) | 23.1 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% | 7.1 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (Dysglycemic) | 7.7 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (Dysglycemic) | 0.0 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% | 0.0 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (Dysglycemic) | 0.0 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 10% (T2DM) | 0.00 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% (T2DM) | 0.00 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 3% (T2DM) | 6.7 Percentage of Participants |
| Placebo | Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 | >= 5% | 0.0 Percentage of Participants |
Comparison: \>= 3% Percent decrease in body weightp-value: 0.3995% CI: [0.344, 15.35]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weightp-value: 0.00295% CI: [2.844, 87.552]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weightp-value: 0.00295% CI: [2.511, 64.32]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weightp-value: <0.00195% CI: [3.362, 84.085]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (Dysglycemic)p-value: 0.72795% CI: [0.087, 33.006]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (Dysglycemic)p-value: 0.01295% CI: [2.066, 386.473]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (Dysglycemic)p-value: 0.05995% CI: [0.914, 116.82]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (Dysglycemic)p-value: 0.06295% CI: [0.891, 100.292]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (T2DM)p-value: 0.33695% CI: [0.265, 48.552]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (T2DM)p-value: 0.07595% CI: [0.799, 103.872]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (T2DM)p-value: 0.00695% CI: [2.665, 322.412]Regression, Logistic
Comparison: \>= 3% Percent decrease in body weight (T2DM)p-value: 0.00395% CI: [3.477, 414.232]Regression, Logistic