Diabetes Mellitus and Heart FailurePhase 2NCT03152552
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
A Phase 2 study testing LIK066 and Empagliflozin in people with Diabetes Mellitus and Heart Failure, run by Novartis Pharmaceuticals at 106 sites in 24 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus and Heart Failure
- What is being tested?
- LIK066 and Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 106 sitesin 24 countries
- Study dates
- 25 Jul 2017to 6 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
106 sites in 24 countries.
106 sites in 24 countries
United States21 sites
Novartis Investigative Site
Bogalusa, Louisiana, 70427
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Carmichael, California, 95608
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Colorado Springs, Colorado, 80906
Novartis Investigative Site
Columbia, South Carolina, 29203
Novartis Investigative Site
Concord, California, 94520
Novartis Investigative Site
Delray Beach, Florida, 33446
Novartis Investigative Site
Fort Lauderdale, Florida, 33312
Novartis Investigative Site
Gurnee, Illinois, 60031
Novartis Investigative Site
Huntsville, Alabama, 35801
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Long Beach, California, 90813
Novartis Investigative Site
Northridge, California, 91325
Novartis Investigative Site
Omaha, Nebraska, 68114
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
St Louis, Missouri, 63128
Novartis Investigative Site
Stockton, California, 95204
Novartis Investigative Site
Sugar Land, Texas, 77479
Novartis Investigative Site
Tacoma, Washington, 98405
Czechia8 sites
Novartis Investigative Site
Brandýs nad Labem, Czech Republic, 250 01
Novartis Investigative Site
Fryštát, 73506
Novartis Investigative Site
Kolín, 280 20
Novartis Investigative Site
Prague, 12808
Novartis Investigative Site
Prague, 158 00
Novartis Investigative Site
Přerov, 751 52
Novartis Investigative Site
Svitavy, Czech Republic, 568 25
Novartis Investigative Site
Třebíč, Czech Republic, 674 01
Germany8 sites
Novartis Investigative Site
Bad Oeynhausen, 32545
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 12157
Novartis Investigative Site
Berlin, 13347
Novartis Investigative Site
Frankfurt, 60594
Novartis Investigative Site
Halle, 06120
Novartis Investigative Site
Hamburg, 20099
Novartis Investigative Site
Stuttgart, 70378
Canada6 sites
Novartis Investigative Site
London, Ontario, N6A 5A5
Novartis Investigative Site
Montreal, Quebec, H4A 3J1
Novartis Investigative Site
Québec, Quebec, G1V 4G2
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 5T3
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Toronto, Ontario, M5B 1W8
Belgium5 sites
Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Bonheiden, 2820
Novartis Investigative Site
Lennik, Brussels Capital, 1070
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Italy5 sites
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, 20149
Novartis Investigative Site
Rimini, 47923
Novartis Investigative Site
San Donato Milanese, MI, 20097
Argentina4 sites
Novartis Investigative Site
Buenos Aires, C1120AAC
Novartis Investigative Site
CABA, Buenos Aires, 1407
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
Novartis Investigative Site
CABA, Buenos Aires F.D., C1179AAB
Bulgaria4 sites
Novartis Investigative Site
Sofia, 1233
Novartis Investigative Site
Sofia, 1309
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Sofia, 1709
Hungary4 sites
Novartis Investigative Site
Budapest, HUN, 1145
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Szeged, 6720
Novartis Investigative Site
Szekszárd, 7100
Netherlands4 sites
Novartis Investigative Site
Alkmaar, 1815 JD
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Utrecht, 3584 CX
Novartis Investigative Site
Venlo, 5912 BL
South Korea4 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Cheongju-si, North Chungcheong, 28644
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426
Spain4 sites
Novartis Investigative Site
Cáceres, Extremadura, 10003
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Villamartín, Cadiz, 11650
United Kingdom4 sites
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Chelmsford, Essex, CM1 7ET
Novartis Investigative Site
London, GBR, EC1M 6BQ
Novartis Investigative Site
Sunderland, Tyne and Wear, SR4 7TP
Austria3 sites
Novartis Investigative Site
Graz, A-8036
Novartis Investigative Site
Vienna, 1090
Novartis Investigative Site
Vienna, 1130
Croatia3 sites
Novartis Investigative Site
Krapinske Toplice, 49 217
Novartis Investigative Site
Rijeka, 51000
Novartis Investigative Site
Zagreb, 10000
Ireland3 sites
Novartis Investigative Site
County Limerick, V94 F858
Novartis Investigative Site
Dublin
Novartis Investigative Site
Wilton, Cork
Norway3 sites
Novartis Investigative Site
Loerenskog, NO 1478
Novartis Investigative Site
Oslo, 0372
Novartis Investigative Site
Trondheim, 7006
South Africa3 sites
Novartis Investigative Site
Bloemfontein, Free State, 9301
Novartis Investigative Site
Paarl, Western Cape, 7626
Novartis Investigative Site
Worcester, 6850
Taiwan3 sites
Novartis Investigative Site
Changhua, 50006
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 11217
Denmark2 sites
Novartis Investigative Site
Hellerup, 2900
Novartis Investigative Site
Svendborg, 5700
Poland2 sites
Novartis Investigative Site
Warsaw, 00-874
Novartis Investigative Site
Wroclaw, 51-314
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Assess the Effect of 3 Doses of LIK066 Compared to Placebo or Empagliflozin in Type 2 Diabetes Mellitus Patients With Heart Failure
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
Read the 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.
- Conditions
- Diabetes Mellitus and Heart Failure
- Being tested
- LIK066, Placebo, Empagliflozin
- 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
- Medical subject headings
- Diabetes Mellitus, Heart Failure, Obesity, Diabetes Mellitus, Type 2, Hypertension, Renal Insufficiency, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIK066Drug
LIK066 was supplied in different doses as tablets taken orally.
PlaceboDrug
Placebo was supplied as tablets and capsules taken orally.
EmpagliflozinDrug
Empagliflozin was supplied as capsules taken orally.
| Study group | Role | What they receive |
|---|---|---|
| LIK066 2.5mg | Experimental | Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks. Receives: Drug: LIK066 |
| LIK066 10mg | Experimental | Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks. Receives: Drug: LIK066 |
| LIK066 50mg | Experimental | Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks. Receives: Drug: LIK066 |
| Empagliflozin | Active comparator | Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks. Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (25)
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.
Measured: Baseline, Week 12, Week 36
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start25 Jul 2017
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Why it stopped: This study terminated prematurely because of slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus and Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152552
- Sponsor's protocol ID
- CLIK066B2204
- Other IDs
- 2016-003084-19, 2016
- Status last verified
- Aug 2019
- First submitted
- 8 May 2017
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group Dose-finding Study to Assess the Effect of 3 Doses of LIK066 Compared to Placebo or Empagliflozin in Type 2 Diabetes Mellitus Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03152552
- Acronym / sponsor ID
- CLIK066B2204
- Conditions
- Diabetes Mellitus and Heart Failure
- Keywords
- Diabetes mellitus, LIK066, Obesity, Type 2 diabetes mellitus (T2DM), Heart Failure (HF), Hypertension, Renal dysfunction, Adult-onset diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study terminated prematurely because of slow enrollment
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LIK066 2.5mg | Experimental | Drug: LIK066Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks. |
| LIK066 10mg | Experimental | Drug: LIK066Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks. |
| LIK066 50mg | Experimental | Drug: LIK066Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks. |
| Empagliflozin | Active comparator | Drug: EmpagliflozinParticipants randomized to this treatment arm received empagliflozin once daily for 36 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIK066LIK066 was supplied in different doses as tablets taken orally. | Drug | LIK066 10mg, LIK066 2.5mg, LIK066 50mg |
| PlaceboPlacebo was supplied as tablets and capsules taken orally. | Drug | Placebo |
| EmpagliflozinEmpagliflozin was supplied as capsules taken orally. | Drug | Empagliflozin |
Primary outcome
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12
Time frame: 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.
25 secondary outcomes
Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Weight at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Left Atrial Size at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Left Atrial Volume at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
Time frame: Baseline, Week 12, Week 36
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
Time frame: Week 12, Week 36
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36
Time frame: Baseline, Week 36
Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
24 Hour Urinary Phosphate Excretion at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36
Time frame: Baseline, Week 12, Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
106 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIK066 and Empagliflozin in people with Diabetes Mellitus and Heart Failure, run by Novartis Pharmaceuticals at 106 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Czechia, Germany, Canada, Belgium and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.