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

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