Skip to content

Henagliflozin for the overweight or obese patients with type 2 diabetes and heart failure: a multicenter, randomized, double-blind, controlled trial

Henagliflozin for the overweight or obese patients with type 2 diabetes and heart failure: a multicenter, randomized, double-blind, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087295
Enrollment
Unknown
Registered
2024-07-24
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes, heart failure

Interventions

Test group:henagliflozin, 5 mg, Qd
Control group:dapagliflozin, 10 mg, Qd

Sponsors

the First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Agree to participate in the study and sign the informed consent form; (2) Age: 18-75 years old; (3) BMI = 25kg/m2, waist circumference = 80cm (female) or = 90cm (male); (4) Type 2 diabetes meets the diagnostic criteria for diabetes in the Chinese Guide for the Prevention and Treatment of Type 2 diabetes, 2020 edition of the Chinese Medical Association; (5) Meets the diagnostic criteria for HFrEF in the 2018 edition of the Chinese Heart Failure Diagnosis and Treatment Guidelines of the Chinese Medical Association.

Exclusion criteria

Exclusion criteria: (1) Patients allergic to SGLT-2 inhibitor drugs; (2) Glomerular filtration rate (eGFR)180mmHg, diastolic blood pressure>100mmHg); (9) Serious illnesses such as severe anemia, neutropenia, organic heart disease, autoimmune diseases, viral hepatitis, cirrhosis, kidney disease, infections, malignant tumors, and uncontrolled mental illnesses; (10) History of frequent urinary and/or reproductive tract infections (= 3 times/year); (11) Pregnant or lactating patients with plans to conceive within the next year; (12) Participated in other clinical trials within 90 days; (13) Any situation that researchers believe may affect efficacy or safety evaluation.

Design outcomes

Primary

MeasureTime frame
Proportion of readmission due to heart failure within 12 months;

Secondary

MeasureTime frame
Glycosylated hemoglobin;left ventricular ejection fraction (LVEF);total cholesterol;Classification of nyha heart function;NTpro-BNP;body weight ;HOMA-IR;

Countries

China

Contacts

Public ContactHao Hu

the First Affiliated Hospital of University of Science and Technology of China

hfroger@163.com+86 185 5653 5771

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026