Trial · NCT03152552
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
NCT03152552, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure. Trials, record NCT03152552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03152552
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
- NCT number
- NCT03152552
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetes Mellitus and Heart Failure
- Interventions
- LIK066, Placebo, Empagliflozin
- First posted
- 2017-05-15
- Last updated
- 2019-08-28
- Other registries' IDs
- eudract:2016-003084-19
- Results first posted
- 2019-08-28
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | Baseline, Week 12 | 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. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Percentage (%) | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Body Weight at Weeks 12 and 36 | Baseline, Week 12, Week 36 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | kilogram (kg) | MEAN |
| SECONDARY | Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Percentage of body fat mass | MEAN |
| SECONDARY | Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Level | MEAN |
| SECONDARY | Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. | Percentage of body fat mass | MEAN |
| SECONDARY | Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | 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. | kilogram (kg) | MEAN |
| SECONDARY | Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | 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. | ||
| SECONDARY | Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36 | Baseline, Week 12, Week 36 | 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. | kilogram (kg) | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group232
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | LIK066 2.5mg | 0.8 | 95% Confidence Interval 0.5 to 1.2 | ratio | |
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | LIK066 10mg | 0.6 | 95% Confidence Interval 0.2 to 1.7 | ratio | |
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | LIK066 50mg | 0.8 | 95% Confidence Interval 0.7 to 1.1 | ratio | |
| Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 | Placebo | 1.1 | 95% Confidence Interval 0.8 to 1.6 | ratio | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | LIK066 2.5mg | Change from BL at Week 12 | -0.29 | Standard Deviation 0.836 | Percentage (%) |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | LIK066 10mg | Change from BL at Week 12 | -0.01 | Standard Deviation 0.508 | Percentage (%) |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | LIK066 50mg | Change from BL at Week 12 | -0.58 | Standard Deviation 0.335 | Percentage (%) |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | EMPA 25mg | Change from BL at Week 12 | -0.44 | Standard Deviation 1.176 | Percentage (%) |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | Placebo | Change from BL at Week 12 | -0.04 | Standard Deviation 0.913 | Percentage (%) |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36 | LIK066 2.5mg | Change from BL at Week 36 | 0.13 | Standard Deviation 0.961 | Percentage (%) |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (12 Weeks) | STARTED | LIK066 2.5mg | 15 | |
| Treatment Period 1 (12 Weeks) | STARTED | LIK066 10mg | 16 | |
| Treatment Period 1 (12 Weeks) | STARTED | LIK066 50mg | 31 | |
| Treatment Period 1 (12 Weeks) | STARTED | EMPA 25mg | 30 | |
| Treatment Period 1 (12 Weeks) | STARTED | Placebo | 33 | |
| Treatment Period 1 (12 Weeks) | Full Analysis Set (FAS) | LIK066 2.5mg | 15 | |
| Treatment Period 1 (12 Weeks) | Full Analysis Set (FAS) | LIK066 10mg | 16 | |
| Treatment Period 1 (12 Weeks) | Full Analysis Set (FAS) | LIK066 50mg | 30 | |
| Treatment Period 1 (12 Weeks) | Full Analysis Set (FAS) | EMPA 25mg | 30 | |
| Treatment Period 1 (12 Weeks) | Full Analysis Set (FAS) | Placebo | 33 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events230
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | LIK066 2.5mg | 0 | 15 | |
| other | Atrial fibrillation | Cardiac disorders | LIK066 10mg | 0 | 16 | |
| other | Atrial fibrillation | Cardiac disorders | LIK066 50mg | 0 | 30 | |
| other | Atrial fibrillation | Cardiac disorders | EMPA 25mg | 2 | 30 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 33 | |
| other | Constipation | Gastrointestinal disorders | LIK066 2.5mg | 0 | 15 | |
| other | Constipation | Gastrointestinal disorders | LIK066 10mg | 1 | 16 | |
| other | Constipation | Gastrointestinal disorders | LIK066 50mg | 0 | 30 | |
| other | Constipation | Gastrointestinal disorders | EMPA 25mg | 1 | 30 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 33 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LIK066 2.5mg | 0 | 15 |
| Total, all-cause mortality | LIK066 10mg | 1 | 16 |
| Total, all-cause mortality | LIK066 50mg | 0 | 30 |
| Total, all-cause mortality | EMPA 25mg | 0 | 30 |
| Total, all-cause mortality | Placebo | 1 | 33 |
| Total, other adverse events | LIK066 2.5mg | 7 | 15 |
| Total, other adverse events | LIK066 10mg | 6 | 16 |
| Total, other adverse events | LIK066 50mg | 8 | 30 |
| Total, other adverse events | EMPA 25mg | 12 | 30 |
| Total, other adverse events | Placebo | 9 | 33 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03152552
GET https://conductscience.org/api/trials/v1/NCT03152552/registered?page=2