Diabetes Mellitus and Heart Failure
Conditions
Keywords
Diabetes mellitus, LIK066, Obesity, Type 2 diabetes mellitus (T2DM), Heart Failure (HF), Hypertension, Renal dysfunction, Adult-onset diabetes, Noninsulin-dependent diabetes mellitus (NIDDM), High blood sugar
Brief summary
This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure
Detailed description
The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would preclude obtaining study results in a timely manner.
Interventions
DRUGLIK066
LIK066 was supplied in different doses as tablets taken orally.
DRUGPlacebo
Placebo was supplied as tablets and capsules taken orally.
DRUGEmpagliflozin
Empagliflozin was supplied as capsules taken orally.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * BMI ≥ 22kg/m\^2 * Type 2 diabetes with HbA1c between 6.5% and 10.0% * Documented symptomatic chronic heart failure (NYHA II-IV) * Plasma NT-proBNP \> 300pg/ml * eGFR ≥ 45ml/min/1.73m\^2 (calculated by MDRD) Key
Exclusion criteria
* Pregnant or nursing (lactating) women * Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * History of ketoacidosis, lactic acidosis, or hyperosmolar coma * Symptomatic genital infection or UTI within 4 weeks of screening * Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization * Unstable angina within 3 months of screening * Isolated right HF due to pulmonary disease * Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization * History of lower limb amputation * Diabetic foot ulcer at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | Baseline, Week 12 | Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this primary endpoint due to early study termination. Only descriptive statistics are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | FPG was measured from a blood sample after an overnight fast; patients were not allowed to eat or drink anything (except water) for at least 8 h before each study visit. Samples were analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in Body Weight at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Body weight was measured to the nearest 0.1 kg on a calibrated scale (weight and bio-impedance measurements), provided by the sponsor. Exceptionally (e.g. if the body weight exceeded the limits of the provided scale) sites were allowed to use another scale for weight measurement as available, but during the study the same scale was to be used for the same patient. The measurement was performed with the study patient in underwear and without shoes. Indoor clothing was also acceptable, but measurements were to be done consistently (either with underwear or with indoor clothing) throughout the study. Voiding before weight measurement was required. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented |
| Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. Visceral fat levels were measured by Omron device. Levels ranged from 1 - 30 and are relative (not absolute) values. The Omron scale values are: 0 - 9 (normal), 10 - 14 (high) and 15 - 30 (very high). Visceral fat area ( 0 - approx. 300cm\^2, 1 inch = 2.54 cm) distribution with 30 levels. |
| Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented |
| Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | A whole body DXA scan was performed to assess Total Body Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done. |
| Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | A whole body DXA scan was performed to assess Visceral Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done. |
| Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | A whole body DXA scan was performed to assess Lean Body Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done. |
| Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | A whole body DXA scan was performed to assess Total Body Water (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Three sitting BP measurements were performed. At each visit, sitting BP was derived as the mean of three readings of the sitting SBP/DBP at that visit. Pre-planned statistical analyses were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | TG was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Lipoproteins (High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol) were measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | HbA1c was measured from a blood sample and analyzed using a National Glycohemoglobin Standardization Program (NGSP) certified method at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | hs-CRP is an inflammation biomarker. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | UGE was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done. |
| Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Sodium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done. |
| Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Baseline, Week 12, Week 36 | A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Baseline, Week 12, Week 36 | A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis.Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Baseline, Week 12, Week 36 | The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12, Week 36 | The change from BL in NYHA class at a given visit is a three-category ordinal variable (improved/unchanged/worsened) with the following definition: 1. Improved, if NYHA class decreases at least one level from BL; 2. Unchanged, if NYHA class is unchanged from BL; 3. Worsened, if NYHA class increases at least one level from BL. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36 | Baseline, Week 36 | Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
| Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Urinary calcium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done. |
| 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Urinary phosphate excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done. |
| Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | To evaluate bone mineral density as assessed by bone mineral content after 12 weeks and after 36 weeks of treatment. Only descriptive statistics were done. |
| Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | Total Cholesterol was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Patients were randomized in a 1:1:2:2:2 ratio to one of 5 regimens (LIK066 2.5mg, 10mg, 50 mg, EMPA 25mg, Pbo) at Visit 201 (randomization) with a plan to be treated for 36 weeks.
Pre-assignment details
A placebo run-in period (Epoch 2) running up to 2 weeks before randomization was used to assess eligibility
Participants by arm
| Arm | Count |
|---|---|
| LIK066 2.5mg LIK066 2.5mg once daily | 15 |
| LIK066 10mg LIk066 10mg once daily | 16 |
| LIK066 50mg LIK066 50mg once daily | 30 |
| EMPA 25mg Empagliflozin 25 mg once daily | 30 |
| Placebo LIK066 matching placebo and empagliflozin matching placebo | 33 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Treatment Period 1 (12 Weeks) | Death | 0 | 1 | 0 | 0 | 1 |
| Treatment Period 1 (12 Weeks) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Treatment Period 1 (12 Weeks) | Protocol deviation | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 1 (12 Weeks) | Study terminated by sponsor | 8 | 9 | 19 | 19 | 20 |
| Treatment Period 1 (12 Weeks) | Subject/guardian decision | 0 | 0 | 0 | 1 | 0 |
| Treatment Period 1 (12 Weeks) | Technical problems | 0 | 0 | 1 | 0 | 0 |
| Treatment Period 2 (24 Weeks) | Study terminated by sponsor | 6 | 5 | 9 | 9 | 11 |
Baseline characteristics
| Characteristic | LIK066 10mg | LIK066 50mg | EMPA 25mg | LIK066 2.5mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 69.8 Years STANDARD_DEVIATION 9.69 | 65.8 Years STANDARD_DEVIATION 9.08 | 68.6 Years STANDARD_DEVIATION 7.89 | 68.2 Years STANDARD_DEVIATION 7.1 | 67.8 Years STANDARD_DEVIATION 10.93 | 67.8 Years STANDARD_DEVIATION 9.17 |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 14 Participants | 28 Participants | 28 Participants | 14 Participants | 29 Participants | 113 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants | 1 Participants | 14 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 20 Participants | 14 Participants | 19 Participants | 89 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 / 15 | 1 / 16 | 0 / 30 | 0 / 30 | 1 / 33 |
| other Total, other adverse events | 7 / 15 | 6 / 16 | 8 / 30 | 12 / 30 | 9 / 33 |
| serious Total, serious adverse events | 2 / 15 | 2 / 16 | 3 / 30 | 5 / 30 | 3 / 33 |
Outcome results
Primary
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12
Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this primary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms are considered per study primary objective.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| LIK066 2.5mg | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | 0.8 ratio |
| LIK066 10mg | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | 0.6 ratio |
| LIK066 50mg | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | 0.8 ratio |
| Placebo | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | 1.1 ratio |
Secondary
24 Hour Urinary Phosphate Excretion at Weeks 12 and 36
Urinary phosphate excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.
Time frame: Baseline, Week 12, Week 36
Population: The Safety Set (SAF), which consisted of all patients who received at least one dose of double-blind study drug, was considered. The analysis included patients who participated in the 24h urine collection sub-study. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 55.35 millimoles per day (mmol/d) | Standard Deviation 25.809 |
| LIK066 10mg | 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 19.25 millimoles per day (mmol/d) | Standard Deviation 55.225 |
| LIK066 50mg | 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36 | Change from BL at Week 12 | -125.95 millimoles per day (mmol/d) | Standard Deviation 105.571 |
| Placebo | 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 5.30 millimoles per day (mmol/d) | — |
| Placebo | 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 26.07 millimoles per day (mmol/d) | Standard Deviation 142.536 |
Secondary
Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36
Sodium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.
Time frame: Baseline, Week 12, Week 36
Population: FAS consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the 24 hour urine collection sub-study. 'Number Analyzed' = number of participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | -38.5 millimoles per 24 hours (mmol/24h) | Standard Deviation 86.69 |
| LIK066 10mg | Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 45.6 millimoles per 24 hours (mmol/24h) | Standard Deviation 40.52 |
| LIK066 50mg | Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | -42.6 millimoles per 24 hours (mmol/24h) | Standard Deviation 28.5 |
| Placebo | Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 82.3 millimoles per 24 hours (mmol/24h) | Standard Deviation 98.29 |
| Placebo | Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | -43.9 millimoles per 24 hours (mmol/24h) | Standard Deviation 112.48 |
Secondary
Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36
Urinary calcium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.
Time frame: Baseline, Week 12, Week 36
Population: Safety Set: All patients who received at least 1 dose of double-blind study drug \& included patients who participated in sub-study. Due to early termination of study, only data shown was available. 'Overall Number of Participants Analyzed' = enrolled in 24h urine collection sub-study. 'Number Analyzed '= number of participants with data available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 1.40 millimoles per day (mmol/d) | — |
| LIK066 10mg | Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 3.80 millimoles per day (mmol/d) | — |
| LIK066 50mg | Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 0.10 millimoles per day (mmol/d) | Standard Deviation 0.566 |
| Placebo | Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | 0.60 millimoles per day (mmol/d) | — |
| Placebo | Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36 | Change from BL at Week 12 | -0.49 millimoles per day (mmol/d) | Standard Deviation 3.202 |
Secondary
Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36
UGE was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.
Time frame: Baseline, Week 12, Week 36
Population: FAS consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the 24 hour urine collection sub-study. 'Number Analyzed' = number of participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 | Change from BL at Week 12 | 256.245 millimoles per 24 hours (mmol/24h) | Standard Deviation 129.0682 |
| LIK066 10mg | Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 | Change from BL at Week 12 | 346.360 millimoles per 24 hours (mmol/24h) | Standard Deviation 107.3671 |
| LIK066 50mg | Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 | Change from BL at Week 12 | 305.110 millimoles per 24 hours (mmol/24h) | — |
| Placebo | Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 | Change from BL at Week 12 | 254.270 millimoles per 24 hours (mmol/24h) | Standard Deviation 198.8243 |
| Placebo | Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 | Change from BL at Week 12 | 84.778 millimoles per 24 hours (mmol/24h) | Standard Deviation 222.6565 |
Secondary
Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36
Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -2.32 Percentage of body fat mass | Standard Deviation 7.063 |
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 36 Chge from BL | -0.85 Percentage of body fat mass | Standard Deviation 1.344 |
| LIK066 10mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -2.32 Percentage of body fat mass | Standard Deviation 5.774 |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 36 Chge from BL | -0.30 Percentage of body fat mass | — |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -0.24 Percentage of body fat mass | Standard Deviation 2.022 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -0.68 Percentage of body fat mass | Standard Deviation 2.454 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 36 Chge from BL | -5.35 Percentage of body fat mass | Standard Deviation 13.223 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | 1.64 Percentage of body fat mass | Standard Deviation 4.584 |
Secondary
Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36
Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -0.77 Percentage of body fat mass | Standard Deviation 2.276 |
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 36 Chge from BL | 2.25 Percentage of body fat mass | Standard Deviation 1.485 |
| LIK066 10mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -1.51 Percentage of body fat mass | Standard Deviation 5.048 |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 36 Chge from BL | 0.20 Percentage of body fat mass | — |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -0.32 Percentage of body fat mass | Standard Deviation 4.675 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | 1.63 Percentage of body fat mass | Standard Deviation 3.639 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 36 Chge from BL | 6.70 Percentage of body fat mass | Standard Deviation 20.082 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Chge from BL | -1.77 Percentage of body fat mass | Standard Deviation 7.812 |
Secondary
Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36
Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. Visceral fat levels were measured by Omron device. Levels ranged from 1 - 30 and are relative (not absolute) values. The Omron scale values are: 0 - 9 (normal), 10 - 14 (high) and 15 - 30 (very high). Visceral fat area ( 0 - approx. 300cm\^2, 1 inch = 2.54 cm) distribution with 30 levels.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 36 Chge from BL | 0.000 Level | Standard Deviation 1.4142 |
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 12 Chge from BL | -2.429 Level | Standard Deviation 4.6853 |
| LIK066 10mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 12 Chge from BL | -2.857 Level | Standard Deviation 3.8914 |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 36 Chge from BL | 0.000 Level | — |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 12 Chge from BL | -0.436 Level | Standard Deviation 4.6877 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 12 Chge from BL | -0.417 Level | Standard Deviation 1.3114 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 36 Chge from BL | 3.500 Level | Standard Deviation 7.7782 |
| Placebo | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Wk 12 Chge from BL | -3.200 Level | Standard Deviation 4.7988 |
Secondary
Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36
A whole body DXA scan was performed to assess Lean Body Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | -1.910 kilogram (kg) |
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | 0.860 kilogram (kg) |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | -1.290 kilogram (kg) |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | -2.960 kilogram (kg) |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | 4.980 kilogram (kg) |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | 1.700 kilogram (kg) |
Secondary
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
A whole body DXA scan was performed to assess Total Body Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | BL Whole Body Minus Head Hologic | 35.970 kilogram (kg) | — |
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | -0.310 kilogram (kg) | — |
| LIK066 2.5mg | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | -3.800 kilogram (kg) | — |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | -1.260 kilogram (kg) | — |
| LIK066 50mg | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | BL Whole Body Minus Head Lunar | 29.350 kilogram (kg) | Standard Deviation 4.9403 |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | 1.190 kilogram (kg) | — |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | BL Whole Body Minus Head Lunar | 37.455 kilogram (kg) | Standard Deviation 6.0175 |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | BL Whole Body Minus Head Hologic | 18.870 kilogram (kg) | — |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | -5.590 kilogram (kg) | — |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | BL Whole Body Minus Head Hologic | 27.550 kilogram (kg) | — |
| Placebo | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | -4.280 kilogram (kg) | — |
Secondary
Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36
A whole body DXA scan was performed to assess Total Body Water (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Time frame: Baseline, Week 12, Week 36
Population: FAS consisted of all randomized patients who were not mis-randomized. Analysis included patients who participated in the DXA sub-study. Due to early termination of the study, no data was collected.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | — |
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | — |
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | — |
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Lunar Chge BL | — |
Secondary
Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36
A whole body DXA scan was performed to assess Visceral Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, no data was collected.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | — |
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | — |
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | — |
| Unknown | Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Lunar Chge BL | — |
Secondary
Change From Baseline in Body Weight at Weeks 12 and 36
Body weight was measured to the nearest 0.1 kg on a calibrated scale (weight and bio-impedance measurements), provided by the sponsor. Exceptionally (e.g. if the body weight exceeded the limits of the provided scale) sites were allowed to use another scale for weight measurement as available, but during the study the same scale was to be used for the same patient. The measurement was performed with the study patient in underwear and without shoes. Indoor clothing was also acceptable, but measurements were to be done consistently (either with underwear or with indoor clothing) throughout the study. Voiding before weight measurement was required. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 12 | -0.78 kilogram (kg) | Standard Deviation 2.734 |
| LIK066 2.5mg | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 36 | -2.21 kilogram (kg) | Standard Deviation 1.586 |
| LIK066 10mg | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 12 | -1.83 kilogram (kg) | Standard Deviation 1.402 |
| LIK066 50mg | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 36 | -3.90 kilogram (kg) | — |
| LIK066 50mg | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 12 | -2.15 kilogram (kg) | Standard Deviation 2.397 |
| Placebo | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 12 | -2.25 kilogram (kg) | Standard Deviation 1.894 |
| Placebo | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 36 | 0.47 kilogram (kg) | Standard Deviation 6.158 |
| Placebo | Change From Baseline in Body Weight at Weeks 12 and 36 | Change from BL at Week 12 | -0.34 kilogram (kg) | Standard Deviation 2.115 |
Secondary
Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36
To evaluate bone mineral density as assessed by bone mineral content after 12 weeks and after 36 weeks of treatment. Only descriptive statistics were done.
Time frame: Baseline, Week 12, Week 36
Population: The Safety Set (SAF), which consisted of all patients who received at least one dose of double-blind study drug, was considered. The analysis included participants who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | -13.250 grams (g) |
| LIK066 2.5mg | Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | -58.220 grams (g) |
| LIK066 50mg | Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | -78.750 grams (g) |
| Placebo | Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Lunar Chge BL | 37.350 grams (g) |
| Placebo | Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Wk 12 Whole Body - Hd Hologic Chge BL | -3.340 grams (g) |
| Placebo | Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36 | Wk 36 Whole Body - Hd Hologic Chge BL | 64.620 grams (g) |
Secondary
Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
Lipoproteins (High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol) were measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 12 | 9.33 Percent change | Standard Deviation 16.735 |
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 36 | 10.70 Percent change | Standard Deviation 16.257 |
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 12 | 22.02 Percent change | Standard Deviation 35.466 |
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 36 | 22.73 Percent change | Standard Deviation 31.69 |
| LIK066 10mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 12 | -10.54 Percent change | Standard Deviation 20.59 |
| LIK066 10mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 12 | 2.62 Percent change | Standard Deviation 17.525 |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 12 | 16.40 Percent change | Standard Deviation 36.928 |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 12 | 0.26 Percent change | Standard Deviation 9.772 |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 36 | 0.00 Percent change | — |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 36 | -3.57 Percent change | — |
| Placebo | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 12 | 2.18 Percent change | Standard Deviation 12.179 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 12 | 22.24 Percent change | Standard Deviation 35.145 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 12 | -1.59 Percent change | Standard Deviation 31.97 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 36 | 35.00 Percent change | Standard Deviation 49.497 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | LDL % Change from BL at Week 36 | 0.22 Percent change | Standard Deviation 13.163 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 | HDL % Change from BL at Week 12 | -0.67 Percent change | Standard Deviation 13.322 |
Secondary
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36
Total Cholesterol was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: FAS consisted of all randomized patients who were not mis-randomized. Analysis included patients who participated in the study. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the study. 'Number Analyzed' = number of participants with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 12 | 9.69 Percent change | Standard Deviation 23.892 |
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 36 | 14.72 Percent change | Standard Deviation 13.147 |
| LIK066 10mg | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 12 | -2.66 Percent change | Standard Deviation 13.202 |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 36 | 2.04 Percent change | — |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 12 | 6.32 Percent change | Standard Deviation 22.667 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 12 | 10.83 Percent change | Standard Deviation 11.33 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 36 | 10.27 Percent change | Standard Deviation 28.326 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36 | % Change from BL at Week 12 | 1.46 Percent change | Standard Deviation 16.741 |
Secondary
Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36
TG was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 12 | -1.623 Percent change | Standard Deviation 35.2838 |
| LIK066 2.5mg | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 36 | 4.324 Percent change | Standard Deviation 31.4438 |
| LIK066 10mg | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 12 | 19.089 Percent change | Standard Deviation 31.4798 |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 36 | 14.286 Percent change | — |
| LIK066 50mg | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 12 | 9.878 Percent change | Standard Deviation 30.3065 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 12 | 8.865 Percent change | Standard Deviation 35.0872 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 36 | -1.111 Percent change | Standard Deviation 18.3586 |
| Placebo | Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36 | % Change from BL at Week 12 | -2.979 Percent change | Standard Deviation 25.1049 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36
FPG was measured from a blood sample after an overnight fast; patients were not allowed to eat or drink anything (except water) for at least 8 h before each study visit. Samples were analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 12 | -1.021 millimoles per litre (mmol/L) | Standard Deviation 1.0368 |
| LIK066 2.5mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 36 | 0.392 millimoles per litre (mmol/L) | Standard Deviation 1.1119 |
| LIK066 10mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 12 | -2.041 millimoles per litre (mmol/L) | Standard Deviation 4.9772 |
| LIK066 50mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 36 | -1.200 millimoles per litre (mmol/L) | — |
| LIK066 50mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 12 | -0.426 millimoles per litre (mmol/L) | Standard Deviation 2.1451 |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 12 | -1.303 millimoles per litre (mmol/L) | Standard Deviation 2.4386 |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 36 | -4.733 millimoles per litre (mmol/L) | Standard Deviation 0.3055 |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Change from BL at Week 12 | -1.187 millimoles per litre (mmol/L) | Standard Deviation 3.9653 |
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36
HbA1c was measured from a blood sample and analyzed using a National Glycohemoglobin Standardization Program (NGSP) certified method at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 12 | -0.29 Percentage (%) | Standard Deviation 0.836 |
| LIK066 2.5mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 36 | 0.13 Percentage (%) | Standard Deviation 0.961 |
| LIK066 10mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 12 | -0.01 Percentage (%) | Standard Deviation 0.508 |
| LIK066 50mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 36 | -0.60 Percentage (%) | — |
| LIK066 50mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 12 | -0.58 Percentage (%) | Standard Deviation 0.335 |
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 12 | -0.44 Percentage (%) | Standard Deviation 1.176 |
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 36 | -1.83 Percentage (%) | Standard Deviation 0.321 |
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Change from BL at Week 12 | -0.04 Percentage (%) | Standard Deviation 0.913 |
Secondary
Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36
hs-CRP is an inflammation biomarker. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 12 | 0.543 milligram per litre (mg/L) |
| LIK066 2.5mg | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 36 | 0.953 milligram per litre (mg/L) |
| LIK066 10mg | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 12 | 0.722 milligram per litre (mg/L) |
| LIK066 50mg | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 36 | 0.620 milligram per litre (mg/L) |
| LIK066 50mg | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 12 | 1.997 milligram per litre (mg/L) |
| Placebo | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 12 | 0.714 milligram per litre (mg/L) |
| Placebo | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 36 | 0.578 milligram per litre (mg/L) |
| Placebo | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36 | Change from BL at Week 12 | 1.018 milligram per litre (mg/L) |
Secondary
Change From Baseline in Left Atrial Size at Weeks 12 and 36
A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 12 | -1.167 milliliter per square meter (mL/m^2) | Standard Deviation 14.8123 |
| LIK066 2.5mg | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 36 | 16.333 milliliter per square meter (mL/m^2) | Standard Deviation 20.9194 |
| LIK066 10mg | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 12 | 0.075 milliliter per square meter (mL/m^2) | Standard Deviation 6.7884 |
| LIK066 50mg | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 36 | 0.300 milliliter per square meter (mL/m^2) | — |
| LIK066 50mg | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 12 | 2.700 milliliter per square meter (mL/m^2) | Standard Deviation 7.2155 |
| Placebo | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 12 | -1.045 milliliter per square meter (mL/m^2) | Standard Deviation 11.0223 |
| Placebo | Change From Baseline in Left Atrial Size at Weeks 12 and 36 | Change from BL at Week 36 | 5.100 milliliter per square meter (mL/m^2) | Standard Deviation 6.296 |
Secondary
Change From Baseline in Left Atrial Volume at Weeks 12 and 36
A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis.Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 12 | 12.360 milliliter (mL) | Standard Deviation 42.7067 |
| LIK066 2.5mg | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 36 | 34.800 milliliter (mL) | Standard Deviation 51.0409 |
| LIK066 10mg | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 12 | 0.225 milliliter (mL) | Standard Deviation 15.4157 |
| LIK066 50mg | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 36 | -0.900 milliliter (mL) | — |
| LIK066 50mg | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 12 | 7.725 milliliter (mL) | Standard Deviation 16.9351 |
| Placebo | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 12 | -3.591 milliliter (mL) | Standard Deviation 22.8382 |
| Placebo | Change From Baseline in Left Atrial Volume at Weeks 12 and 36 | Change from BL at Week 36 | 11.333 milliliter (mL) | Standard Deviation 12.7892 |
Secondary
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36
Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms are considered per study objective. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| LIK066 2.5mg | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36 | 0.7 ratio |
| LIK066 50mg | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36 | 1.3 ratio |
| Placebo | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36 | 1.0 ratio |
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
Three sitting BP measurements were performed. At each visit, sitting BP was derived as the mean of three readings of the sitting SBP/DBP at that visit. Pre-planned statistical analyses were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIK066 2.5mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 12 | 5.15 millimeter of mercury (mmHg) | Standard Deviation 13.485 |
| LIK066 2.5mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 36 | 13.78 millimeter of mercury (mmHg) | Standard Deviation 17.9 |
| LIK066 2.5mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 12 | -2.00 millimeter of mercury (mmHg) | Standard Deviation 6.582 |
| LIK066 2.5mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 36 | 1.12 millimeter of mercury (mmHg) | Standard Deviation 3.975 |
| LIK066 10mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 12 | 0.17 millimeter of mercury (mmHg) | Standard Deviation 15.373 |
| LIK066 10mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 12 | 4.50 millimeter of mercury (mmHg) | Standard Deviation 12.746 |
| LIK066 50mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 12 | -4.46 millimeter of mercury (mmHg) | Standard Deviation 11.238 |
| LIK066 50mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 12 | -9.54 millimeter of mercury (mmHg) | Standard Deviation 16.884 |
| LIK066 50mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 36 | -4.00 millimeter of mercury (mmHg) | — |
| LIK066 50mg | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 36 | 3.66 millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 12 | -6.98 millimeter of mercury (mmHg) | Standard Deviation 15.031 |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 12 | -1.81 millimeter of mercury (mmHg) | Standard Deviation 10.421 |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 12 | -2.00 millimeter of mercury (mmHg) | Standard Deviation 8.596 |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 36 | 0.00 millimeter of mercury (mmHg) | Standard Deviation 8.627 |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | DBP Change from BL at Week 36 | -0.44 millimeter of mercury (mmHg) | Standard Deviation 8.517 |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36 | SBP Change from BL at Week 12 | -2.85 millimeter of mercury (mmHg) | Standard Deviation 11.967 |
Secondary
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
The change from BL in NYHA class at a given visit is a three-category ordinal variable (improved/unchanged/worsened) with the following definition: 1. Improved, if NYHA class decreases at least one level from BL; 2. Unchanged, if NYHA class is unchanged from BL; 3. Worsened, if NYHA class increases at least one level from BL. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LIK066 2.5mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Improved | 1 Participants |
| LIK066 2.5mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Unchanged | 8 Participants |
| LIK066 2.5mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Worsened | 0 Participants |
| LIK066 2.5mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Improved | 0 Participants |
| LIK066 2.5mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Unchanged | 3 Participants |
| LIK066 2.5mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Worsened | 0 Participants |
| LIK066 10mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Worsened | 0 Participants |
| LIK066 10mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Improved | 0 Participants |
| LIK066 10mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Improved | 1 Participants |
| LIK066 10mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Worsened | 0 Participants |
| LIK066 10mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Unchanged | 7 Participants |
| LIK066 10mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Unchanged | 0 Participants |
| LIK066 50mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Unchanged | 12 Participants |
| LIK066 50mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Worsened | 0 Participants |
| LIK066 50mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Improved | 0 Participants |
| LIK066 50mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Worsened | 0 Participants |
| LIK066 50mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Unchanged | 1 Participants |
| LIK066 50mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Improved | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Unchanged | 3 Participants |
| Placebo | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Worsened | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Unchanged | 13 Participants |
| Placebo | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 36 | Improved | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Improved | 4 Participants |
| Placebo | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 | Week 12 | Worsened | 1 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.
Time frame: Baseline, Week 12, Week 36
Population: The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class l | 1 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class ll | 6 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lll | 2 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lV | 0 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class l | 0 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class ll | 3 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lll | 0 Participants |
| LIK066 2.5mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lV | 0 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class ll | 0 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class l | 0 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class ll | 6 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lV | 0 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lll | 0 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lV | 0 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lll | 1 Participants |
| LIK066 10mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class l | 1 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lll | 0 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lll | 2 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lV | 0 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class l | 0 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class ll | 1 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lV | 0 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class l | 1 Participants |
| LIK066 50mg | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class ll | 10 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lll | 4 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class lV | 0 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class ll | 13 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 12 | Class l | 1 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class l | 0 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lV | 0 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class lll | 0 Participants |
| Placebo | Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV | Week 36 | Class ll | 3 Participants |