The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics

Launched by RENJI HOSPITAL · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, henagliflozin and metformin, on heart tissue in patients with type 2 diabetes and obesity. The goal is to see how these drugs may help improve heart health by looking at changes in heart tissue over a 24-week period. Participants will be randomly assigned to take either henagliflozin once a day or metformin twice a day. The trial is not yet recruiting participants but aims to include adults between 18 and 75 years old who have been newly diagnosed with type 2 diabetes.

To be eligible for the trial, participants should have specific blood sugar levels and should not have certain health conditions that could interfere with the study, such as type 1 diabetes or significant heart problems. Throughout the study, participants will have five visits to monitor their health and how they respond to the medications. This trial is an opportunity for individuals with type 2 diabetes to potentially contribute to important research on improving heart health while managing their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals with type 2 diabetes newly diagnosed based on the WHO (1999) criteria;
• • Hemoglobin A1c levels \>=7.0% and \<=8.0%;
• • Females or males ≥18 years up to 75 years of age.
• Exclusion Criteria:
• • Females or males \<18 years.
• • Clinical diagnosis of type 1 diabetes and other types of diabetes.
• • Blood pressure at screening that would require a change in blood pressure treatment over the study period.
• • History of stroke or other clinically significant cerebrovascular disease.
• * Any of the following cardiovascular diseases:
• • 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function
• • 2. Unstable heart failure or any heart failure with NYHA class III and IV
• • 3. Significant valvular disease
• • 4. Significant peripheral artery disease
• • Active malignancy requiring treatment at the time of visit 0.
• • Patients with severe hepatic impairment.
• • Unstable or rapidly progressing renal disease.
• • Ongoing treatment with loop diuretics.
• • Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min/1.73 m2.
• • Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.