Clinical 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Noninsulin-dependent diabetes mellitus (NIDDM)
High blood sugar
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-05-15
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure

Detailed description: The study was prematurely discontinued on 04-May-2018 due to slow enrollment that would preclude obtaining study results in a timely manner.

Eligibility criteria: Key Inclusion Criteria:

* BMI ≥ 22kg/m\^2
* Type 2 diabetes with HbA1c between 6.5% and 10.0%
* Documented symptomatic chronic heart failure (NYHA II-IV)
* Plasma NT-proBNP \> 300pg/ml
* eGFR ≥ 45ml/min/1.73m\^2 (calculated by MDRD)

Key Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* History of ketoacidosis, lactic acidosis, or hyperosmolar coma
* Symptomatic genital infection or UTI within 4 weeks of screening
* Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization
* Unstable angina within 3 months of screening
* Isolated right HF due to pulmonary disease
* Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization
* History of lower limb amputation
* Diabetic foot ulcer at screening

Primary outcomes:
measure: Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Weight at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Left Atrial Size at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Left Atrial Volume at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV
timeFrame: Baseline, Week 12, Week 36
measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36
timeFrame: Week 12, Week 36
measure: Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: 24 Hour Urinary Phosphate Excretion at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
measure: Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36
timeFrame: Baseline, Week 12, Week 36
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Carmichael
country: United States
facility: Novartis Investigative Site
state: California
city: Concord
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Northridge
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Delray Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Gurnee
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Bogalusa
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Sugar Land
country: United States
facility: Novartis Investigative Site
state: Texas
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Lennik
country: Belgium
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state: Brussels
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: London
country: Canada
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state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Jerome
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Krapinske toplice
country: Croatia
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Brandys nad Labem
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Svitavy
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Trebic
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Karvina
country: Czechia
facility: Novartis Investigative Site
city: Kolin
country: Czechia
facility: Novartis Investigative Site
city: Prague 5
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
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city: Prerov
country: Czechia
facility: Novartis Investigative Site
city: Hellerup
country: Denmark
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city: Svendborg
country: Denmark
facility: Novartis Investigative Site
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szekszard
country: Hungary
facility: Novartis Investigative Site
city: Wilton
country: Ireland
facility: Novartis Investigative Site
state: Cork
city: County Limerick
country: Ireland
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: San Donato Milanese
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Rimini
country: Italy
facility: Novartis Investigative Site
city: Cheongju si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Chungcheongbuk Do
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-Do
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Durango
country: Mexico
facility: Novartis Investigative Site
city: Alkmaar
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Venlo
country: Netherlands
facility: Novartis Investigative Site
city: Loerenskog
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Trondheim
country: Norway
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Ponce
country: Puerto Rico
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
state: Free State
city: Paarl
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
city: Worcester
country: South Africa
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Villamartin
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Chelmsford
country: United Kingdom
facility: Novartis Investigative Site
state: Essex
city: London
country: United Kingdom
facility: Novartis Investigative Site
state: GBR
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: