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

• Status: Terminated
• Trial end date: 2018-06-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Empagliflozin; Licogliflozin

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