Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003084-19 | EudraCT Number |
Not provided
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This study terminated prematurely because of slow enrollment
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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
The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would preclude obtaining study results in a timely manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIK066 2.5mg | Experimental | Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks. |
|
| LIK066 10mg | Experimental | Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks. |
|
| LIK066 50mg | Experimental | Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks. |
|
| Empagliflozin | Active Comparator | Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks. |
|
| Placebo | Placebo Comparator | Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIK066 | Drug | LIK066 was supplied in different doses as tablets taken orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12, Week 36 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Huntsville | Alabama | 35801 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A placebo run-in period (Epoch 2) running up to 2 weeks before randomization was used to assess eligibility
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LIK066 2.5mg | LIK066 2.5mg once daily |
| FG001 | LIK066 10mg | LIk066 10mg once daily |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Period 1 (12 Weeks) |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2018 | Apr 11, 2019 |
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| Placebo | Drug | Placebo was supplied as tablets and capsules taken orally. |
|
| Empagliflozin | Drug | Empagliflozin was supplied as capsules taken orally. |
|
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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 | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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 | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Week 12, Week 36 |
| 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. | Baseline, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| 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. | Baseline, Week 12, Week 36 |
| Carmichael |
| California |
| 95608 |
| United States |
| Novartis Investigative Site | Concord | California | 94520 | United States |
| Novartis Investigative Site | Long Beach | California | 90813 | United States |
| Novartis Investigative Site | Northridge | California | 91325 | United States |
| Novartis Investigative Site | Stockton | California | 95204 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80906 | United States |
| Novartis Investigative Site | Bradenton | Florida | 34209 | United States |
| Novartis Investigative Site | Clearwater | Florida | 33756 | United States |
| Novartis Investigative Site | Delray Beach | Florida | 33446 | United States |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33312 | United States |
| Novartis Investigative Site | Gurnee | Illinois | 60031 | United States |
| Novartis Investigative Site | Bogalusa | Louisiana | 70427 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63128 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29407 | United States |
| Novartis Investigative Site | Columbia | South Carolina | 29203 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Sugar Land | Texas | 77479 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | 1407 | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires F.D. | C1179AAB | Argentina |
| Novartis Investigative Site | Buenos Aires | C1120AAC | Argentina |
| Novartis Investigative Site | Graz | A-8036 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Vienna | 1130 | Austria |
| Novartis Investigative Site | Lennik | Brussels Capital | 1070 | Belgium |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
| Novartis Investigative Site | Bonheiden | 2820 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Sofia | 1233 | Bulgaria |
| Novartis Investigative Site | Sofia | 1309 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Sofia | 1709 | Bulgaria |
| Novartis Investigative Site | London | Ontario | N6A 5A5 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5B 1W8 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H4A 3J1 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1V 4G2 | Canada |
| Novartis Investigative Site | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Novartis Investigative Site | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Novartis Investigative Site | Krapinske Toplice | 49 217 | Croatia |
| Novartis Investigative Site | Rijeka | 51000 | Croatia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Brandýs nad Labem | Czech Republic | 250 01 | Czechia |
| Novartis Investigative Site | Svitavy | Czech Republic | 568 25 | Czechia |
| Novartis Investigative Site | Třebíč | Czech Republic | 674 01 | Czechia |
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| Novartis Investigative Site | Bad Oeynhausen | 32545 | Germany |
| Novartis Investigative Site | Berlin | 10789 | Germany |
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| Novartis Investigative Site | Frankfurt | 60594 | Germany |
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| Novartis Investigative Site | Hamburg | 20099 | Germany |
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| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Bergamo | BG | 24127 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | San Donato Milanese | MI | 20097 | Italy |
| Novartis Investigative Site | Milan | 20149 | Italy |
| Novartis Investigative Site | Rimini | 47923 | Italy |
| Novartis Investigative Site | Durango | 34000 | Mexico |
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| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Utrecht | 3584 CX | Netherlands |
| Novartis Investigative Site | Venlo | 5912 BL | Netherlands |
| Novartis Investigative Site | Loerenskog | NO 1478 | Norway |
| Novartis Investigative Site | Oslo | 0372 | Norway |
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| Novartis Investigative Site | Warsaw | 00-874 | Poland |
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| Novartis Investigative Site | Ponce | 00717 | Puerto Rico |
| Novartis Investigative Site | Singapore | 169609 | Singapore |
| Novartis Investigative Site | Bloemfontein | Free State | 9301 | South Africa |
| Novartis Investigative Site | Paarl | Western Cape | 7626 | South Africa |
| Novartis Investigative Site | Worcester | 6850 | South Africa |
| Novartis Investigative Site | Wŏnju | Gangwon-do | 26426 | South Korea |
| Novartis Investigative Site | Bundang Gu | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seville | Andalusia | 41014 | Spain |
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| Novartis Investigative Site | Cáceres | Extremadura | 10003 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Changhua | 50006 | Taiwan |
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| Novartis Investigative Site | Chelmsford | Essex | CM1 7ET | United Kingdom |
| Novartis Investigative Site | London | GBR | EC1M 6BQ | United Kingdom |
| Novartis Investigative Site | Sunderland | Tyne and Wear | SR4 7TP | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2TH | United Kingdom |
| FG002 |
| LIK066 50mg |
LIK066 50mg once daily |
| FG003 | EMPA 25mg | Empagliflozin 25 mg once daily |
| FG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
| Full Analysis Set (FAS) | All patients in RAN who were not mis-randomized |
|
| COMPLETED | Completed EPOCH 3 (double-blind period 1) |
|
| NOT COMPLETED |
|
|
| Treatment Period 2 (24 Weeks) |
|
|
The Baseline Characteristics and efficacy analyses were done on Full Analysis Set (FAS). One patient from the LIK066 50 mg group, was misrandomized,and had not taken any study medication and thus was excluded from the Full analysis set (FAS) and the Safety analysis set (SAF).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LIK066 2.5mg | LIK066 2.5mg once daily |
| BG001 | LIK066 10mg | LIk066 10mg once daily |
| BG002 | LIK066 50mg | LIK066 50mg once daily |
| BG003 | EMPA 25mg | Empagliflozin 25 mg once daily |
| BG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Posted | Mean | Standard Deviation | Percentage (%) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Posted | Mean | Standard Deviation | millimoles per litre (mmol/L) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Posted | Mean | Standard Deviation | Percentage of body fat mass | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Posted | Mean | Standard Deviation | Level | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Posted | Mean | Standard Deviation | Percentage of body fat mass | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Baseline, Week 12, Week 36 |
| |||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Baseline, Week 12, Week 36 |
| |||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 12, Week 36 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | milligram per litre (mg/L) | Baseline, Week 12, Week 36 |
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| 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. | 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. | Posted | Mean | Standard Deviation | millimoles per 24 hours (mmol/24h) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimoles per 24 hours (mmol/24h) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | milliliter per square meter (mL/m^2) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | milliliter (mL) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | No | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | No | Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Mean | Standard Deviation | millimoles per day (mmol/d) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimoles per day (mmol/d) | Baseline, Week 12, Week 36 |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | grams (g) | Baseline, Week 12, Week 36 |
|
Adverse events (AEs) and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 253 days. Treatment emergent AEs are represented for the double-blind period (i.e., starting from randomization to the end of the double-blind period). Total duration of the double-blind period was planned for approximately 36 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LIK066 2.5mg | LIK066 2.5mg once daily | 0 | 15 | 2 | 15 | 7 | 15 |
| EG001 | LIK066 10mg | LIK066 10mg once daily | 1 | 16 | 2 | 16 | 6 | 16 |
| EG002 | LIK066 50mg | LIK066 50mg once daily | 0 | 30 | 3 | 30 | 8 | 30 |
| EG003 | EMPA 25mg | Empagliflozin 25 mg once daily | 0 | 30 | 5 | 30 | 12 | 30 |
| EG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo | 1 | 33 | 3 | 33 | 9 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Cerebral vascular occlusion | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Genital infection fungal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
Due to early discontinuation of the study, the analysis of efficacy was done on the available data (mostly for Epoch 3 (double-blind period 1) only). Because of the small sample sizes the interpretation of the results remained limited.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2018 | Apr 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D051437 | Renal Insufficiency |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709456 | licogliflozin |
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG003 | EMPA 25mg | Empagliflozin 25 mg once daily |
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG003 | EMPA 25mg | Empagliflozin 25 mg once daily |
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 |
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 |
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
Empagliflozin 25 mg once daily
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 |
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 |
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
| OG004 |
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
|
|
|
|
| OG002 | LIK066 50mg | LIK066 50mg once daily |
| OG003 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
|
|
| OG004 | Placebo | LIK066 matching placebo and empagliflozin matching placebo |
|
|
| Placebo |
LIK066 matching placebo and empagliflozin matching placebo |
|
|
LIK066 matching placebo and empagliflozin matching placebo |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Class ll |
|
| Class lll |
|
| Class lV |
|
| Title | Measurements |
|---|---|
| Class l |
|
| Class ll |
|
| Class lll |
|
| Class lV |
|
| Unchanged |
|
| Worsened |
|
| Title | Measurements |
|---|---|
| Improved |
|
| Unchanged |
|
| Worsened |
|
|
|