patients with type 2 diabetes mellitus and heart failure MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861 MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: LIK066 2.5 mg
Product Code: LIK066
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LIK066
Concentration unit: mg milligram(s)
Concentra
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 460
Exclusion criteria
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 screening • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the 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 in T2DM patients with HF ;Secondary Objective: 1. To evaluate the effect of all LIK066 doses vs placebo or empagliflozin at 12 weeks and 36 weeks on: - Change from baseline (BL) in HbA1c - Change from BL in fasting plasma glucose - Change from BL in body weight - Change from BL in body composition - Change from BL in sitting SBP and DBP - Change from BL in 24h urinary glucose and sodium excretion - Change from BL in the fasting lipid profile and hsCRP 2. Change from BL in left atrial size and volume assessed by echocardiography relative to placebo after 12 and 36 weeks of treatment 3. Change from BL in NYHA class relative to placebo after 12 and 36 weeks of treatment 4. To evaluate the change from BL to 36 weeks in all LIK066 doses vs placebo on NT-proBNP. 5. To evaluate bone mineral density and 24h urinary calcium and phosphate excretion;Primary end point(s): Change from baseline in NTproBNP at week 12;Timepoint(s) of evaluation of this end point: baseline, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline (BL) in HbA1c - Change from BL in fasting plasma glucose - Change from BL in body weight - Change from BL in body composition - Change from BL in sitting SBP and DBP - Change from BL in the fasting lipid profile and hsCRP - Change from BL in 24h urinary glucose and sodium excretion - Change from BL in left atrial size and volume assessed by echocardiography - Change from BL in NYHA class - Change from BL in NT-proBNP - 24h urinary calcium and phosphate excretion - bone mineral density ;Timepoint(s) of evaluation of this end point: baseline, week 12, week 36 | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Germany, Guatemala, Hungary, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed