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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

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ClinicalTrials.gov Identifier: NCT03152552
Recruitment Status : Terminated (This study terminated prematurely because of slow enrollment that would preclude obtaining study results in a timely manner.)
First Posted : May 15, 2017
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: LIK066 Drug: Placebo Drug: Empagliflozin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : June 6, 2018
Actual Study Completion Date : June 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: LIK066
Eligible patients randomized to these treatment arms will receive different LIK066 dose regimens (dose A once daily, dose B once daily or dose C once daily) for 36 weeks.
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Active Comparator: Empagliflozin
Patients randomized to this treatment arm will receive empagliflozin once daily for 36 weeks.
Drug: Empagliflozin
Empagliflozin will be supplied as capsules to be taken orally.

Placebo Comparator: Placebo
Patients randomized to this treatment arm will receive LIK066 matching placebo and empagliflozin matching placebo.
Drug: Placebo
Placebo will be supplied as tablets and capsules to be taken orally.




Primary Outcome Measures :
  1. Change from Baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Dose-response relationship of three dose regimens of LIK066 as measured by the change from baseline in NT-proBNP relative to placebo after 12 weeks of treatment


Secondary Outcome Measures :
  1. Change from Baseline in glycated hemoglobin (HbA1c) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in glycated hemoglobin A1c relative to placebo or empagliflozion after 12 weeks and 36 weeks of treatment

  2. Change from Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in fasting plasma glucose relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  3. Change from Baseline in Body Weight at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in body weight relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  4. Change from Baseline in Body Composition at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in body composition relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  5. Change from Baseline in sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (SDP) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in sitting systolic blood pressure and diastolic blood pressure relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  6. Change from Baseline in 24 hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in 24 hour urinary glucose excretion relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  7. Change from Baseline in Left Atrial Size at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in left atrial size assessed by echocardiography relative to placebo after 12 weeks and 36 weeks of treatment

  8. Percentage of participants with change from Baseline in New York Heart Association (NYHA) Class at Week 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in NYHA class relative to placebo after 12 weeks and 36 weeks of treatment

  9. Change from Baseline in Fasting Lipid Profile (Triglycerides and Cholesterol) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in fasting lipid profile (triglycerides/cholesterol) relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  10. Change from Baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) at Week 36 [ Time Frame: Baseline, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in NT-proBNP relative to placebo after 36 weeks of treatment

  11. 24 hour urinary calcium excretion [ Time Frame: Baseline, Week 12, Week 36 ]
    To evaluate 24 hour urinary calcium excretion after 12 weeks and after 36 weeks of treatment

  12. Bone mineral density [ Time Frame: Baseline, Week 12, Week 36 ]
    To evaluate bone mineral density after 12 weeks and after 36 weeks of treatment

  13. Change from Baseline in High sensitive C-reactive protein (hsCRP) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in hsCRP relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  14. Change from Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in fasting lipid profile (lipoproteins) relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  15. Change from baseline in Left Atrial Volume at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in left atrial volume assessed by echocardiography relative to placebo after 12 weeks and 36 weeks of treatment

  16. Change from Baseline in 24 hour Sodium Excretion at Weeks 12 and 36 [ Time Frame: Baseline, Week 12, Week 36 ]
    Effect of three dose regimens of LIK066 as measured by change from baseline in 24 hour sodium excretion relative to placebo or empagliflozin after 12 weeks and 36 weeks of treatment

  17. 24 hour urinary phosphate excretion [ Time Frame: Baseline, Week 12, Week 36 ]
    To evaluate 24 hour urinary phosphate excretion after 12 weeks and after 36 weeks of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152552


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03152552     History of Changes
Other Study ID Numbers: CLIK066B2204
2016-003084-19 ( EudraCT Number )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes mellitus (T2DM)
Heart Failure (HF)
Hypertension
Renal dysfunction
Adult-onset diabetes
Noninsulin-dependent diabetes mellitus (NIDDM)
High blood sugar

Additional relevant MeSH terms:
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Empagliflozin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs