A study to assess the effect of 3 different doses of LIK066 in patients with type 2 diabetes and heart failure, compared to the effect of placebo or empagliflozi

Phase 1

• Conditions: patients with type 2 diabetes mellitus and heart failure; MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003084-19-PL
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-26
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified