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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

Primary Purpose

Diabetes Mellitus and Heart Failure

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LIK066

Placebo

Empagliflozin

About this trial

This is an interventional treatment trial for Diabetes Mellitus and Heart Failure focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

LIK066 2.5mg

LIK066 10mg

LIK066 50mg

Empagliflozin

Placebo

Arm Description

Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks.

Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks.

Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks.

Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks.

Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 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.

Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03152552

First Posted

May 8, 2017

Last Updated

August 9, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03152552

Brief 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

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Why Stopped

This study terminated prematurely because of slow enrollment

Study Start Date

July 25, 2017 (Actual)

Primary Completion Date

June 6, 2018 (Actual)

Study Completion Date

June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIK066 2.5mg

Arm Type

Experimental

Arm Description

Eligible participants randomized to this treatment arm received the LIK066 2.5mg dose regimen once daily for 36 weeks.

Arm Title

LIK066 10mg

Arm Type

Experimental

Arm Description

Eligible participants randomized to this treatment arm received the LIK066 10mg dose regimen once daily for 36 weeks.

Arm Title

LIK066 50mg

Arm Type

Experimental

Arm Description

Eligible participants randomized to this treatment arm received the LIK066 50mg dose regimen once daily for 36 weeks.

Arm Title

Empagliflozin

Arm Type

Active Comparator

Arm Description

Participants randomized to this treatment arm received empagliflozin once daily for 36 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants randomized to this treatment arm received LIK066 matching placebo and empagliflozin matching placebo.

Intervention Type

Drug

Intervention Name(s)

LIK066

Intervention Description

LIK066 was supplied in different doses as tablets taken orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was supplied as tablets and capsules taken orally.

Intervention Type

Drug

Intervention Name(s)

Empagliflozin

Intervention Description

Empagliflozin was supplied as capsules taken orally.

Primary Outcome Measure Information:

Title

Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Weight at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36

Description

UGE was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36

Description

Sodium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Left Atrial Size at Weeks 12 and 36

Description

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Left Atrial Volume at Weeks 12 and 36

Description

A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis.Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.

Time Frame

Baseline, Week 12, Week 36

Title

Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV

Description

Time Frame

Baseline, Week 12, Week 36

Title

Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36

Description

Time Frame

Week 12, Week 36

Title

Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36

Description

Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.

Time Frame

Baseline, Week 36

Title

Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36

Description

Urinary calcium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.

Time Frame

Baseline, Week 12, Week 36

Title

24 Hour Urinary Phosphate Excretion at Weeks 12 and 36

Description

Urinary phosphate excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.

Time Frame

Baseline, Week 12, Week 36

Title

Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36

Description

To evaluate bone mineral density as assessed by bone mineral content after 12 weeks and after 36 weeks of treatment. Only descriptive statistics were done.

Time Frame

Baseline, Week 12, Week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Novartis Investigative Site

City

Carmichael

State/Province

California

ZIP/Postal Code

95608

Country

United States

Facility Name

Novartis Investigative Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Novartis Investigative Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Novartis Investigative Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novartis Investigative Site

City

Stockton

State/Province

California

ZIP/Postal Code

95204

Country

United States

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80906

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Novartis Investigative Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Novartis Investigative Site

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33446

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

Novartis Investigative Site

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Novartis Investigative Site

City

Bogalusa

State/Province

Louisiana

ZIP/Postal Code

70427

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39209

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Novartis Investigative Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1407

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Capital Federal

ZIP/Postal Code

C1179AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1120AAC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novartis Investigative Site

City

Lennik

State/Province

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Novartis Investigative Site

City

Sainte Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Jerome

State/Province

Quebec

ZIP/Postal Code

J7Z 5T3

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Krapinske toplice

ZIP/Postal Code

49 217

Country

Croatia

Facility Name

Novartis Investigative Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Brandys nad Labem

State/Province

Czech Republic

ZIP/Postal Code

250 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Svitavy

State/Province

Czech Republic

ZIP/Postal Code

568 25

Country

Czechia

Facility Name

Novartis Investigative Site

City

Trebic

State/Province

Czech Republic

ZIP/Postal Code

674 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Karvina

ZIP/Postal Code

73506

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kolin

ZIP/Postal Code

280 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 5

ZIP/Postal Code

158 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prerov

ZIP/Postal Code

751 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Novartis Investigative Site

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

Novartis Investigative Site

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60594

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70378

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Wilton

State/Province

Cork

Country

Ireland

Facility Name

Novartis Investigative Site

City

County Limerick

ZIP/Postal Code

V94 F858

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin 4

Country

Ireland

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

San Donato Milanese

State/Province

ZIP/Postal Code

20097

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

ZIP/Postal Code

20149

Country

Italy

Facility Name

Novartis Investigative Site

City

Rimini

ZIP/Postal Code

47923

Country

Italy

Facility Name

Novartis Investigative Site

City

Cheongju si

State/Province

Chungcheongbuk Do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon-Do

ZIP/Postal Code

26426

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Bundang Gu

State/Province

Gyeonggi Do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Loerenskog

ZIP/Postal Code

NO 1478

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0372

Country

Norway

Facility Name

Novartis Investigative Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

00-874

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-314

Country

Poland

Facility Name

Novartis Investigative Site

City

Ponce

ZIP/Postal Code

00717

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169609

Country

Singapore

Facility Name

Novartis Investigative Site

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Novartis Investigative Site

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7626

Country

South Africa

Facility Name

Novartis Investigative Site

City

Worcester

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novartis Investigative Site

City

Villamartin

State/Province

Cadiz

ZIP/Postal Code

11650

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Chelmsford

State/Province

Essex

ZIP/Postal Code

CM1 7ET

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

State/Province

GBR

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sunderland

State/Province

Tyne And Wear

ZIP/Postal Code

SR4 7TP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Learn more about this trial

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

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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

Diabetes Mellitus and Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial