Type2 diabetes and obesity-related heart failure with preserved ejection fraction
Conditions
Interventions
semaglutide subcutaneous (s.c.) 2.4 mg once-weekly added to standard of care
Sponsors
Kinoshita Kazunori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female, age above or equal to 20 years at the time of signing informed consent. -Body mass index (BMI) >=30.0 kg/m2 -New York Heart Association (NYHA) Class II-IV -Left ventricular ejection fraction (LVEF) >= 45% at screening -Diagnosed with T2D >= 90 days prior to the day of screening -HbA1c of <= 10.0% as measured at the screening visit
Exclusion criteria
Exclusion criteria: -A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records -Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple primary endpoints -Change in KCCQ clinical summary -score (no unit, range; 0-100) From baseline (week 0) to end of treatment (week 52) -Change in body weight (%) From baseline (week 0) to end of treatment (week 52) | — |
Countries
Argentina, Austria, Canada, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactKazunori Kinoshita
Novo Nordisk Pharma Ltd.
Outcome results
None listed