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Effect of canagliflozin on cardiac function in patients with type 2 diabetes mellitus and high cardiovascular risk

Effect of canagliflozin on cardiac function in patients with type 2 diabetes mellitus and high cardiovascular risk: a multicenter, prospective, randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051190
Enrollment
Unknown
Registered
2021-09-15
Start date
2021-10-08
Completion date
Unknown
Last updated
2022-05-23

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

Conditions

Type 2 diabetes

Interventions

Sponsors

The Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged > 18 and = 7.0% and = 10 years, and the presence of the following >= 2 risk factors: male > 55 years old, female > 65 years old; BMI >= 25 kg/m2; hypertension (taking antihypertensive drugs or newly diagnosed hypertension patients); dyslipidemia; current smokers (Brinkman index >= 200); (2) any of the following target organ damage markers: proteinuria (ACR >= 300 mg/g), 45ml/min/1.73 m2 50%; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating women and women of childbearing age who are unwilling to take reliable contraceptive measures; 2. Known allergic to canagliflozin/sitagliptin; 3. Patients with hypovolemia judged by clinicians, or patients with a history of amputation, peripheral vascular disease or diabetic foot ulcers; 4. Diagnosed history of the following cardiovascular diseases: including myocardial infarction, hospitalization for unstable angina, cerebral infarction (ischemic stroke), coronary artery bypass grafting, percutaneous coronary intervention (with or without stentless), peripheral revascularization (angioplasty or surgery), heart failure, arrhythmias, valvular heart disease; 5. AST, ALT >= 3 times the upper limit of normal; 6. Diabetic ketosis or diabetic hyperosmolar coma; 7. Diagnosed respiratory diseases (such as chronic obstructive pulmonary disease, pulmonary hypertension, etc.); 8. Hypertensive emergencies (systolic/diastolic blood pressure over 180/120mmHg) at the time of enrollment, or refractory hypertension (systolic blood pressure still > 140 or diastolic blood pressure after treatment with a full dose of 3 antihypertensive drugs) > 90mmHg); 9. It is known that there is impaired gastrointestinal function or gastrointestinal diseases that may significantly affect the absorption of the test drug, such as: diagnosed active ulcers (Forrest grade II and below), inflammatory bowel disease, and malabsorption related diseases, and uncontrolled diarrhea, gastrointestinal surgery (eg, bariatric surgery); 10. Patients with diagnosed malignant tumor; 11. Patients who participated in other clinical trials within 3 months; 12. In addition to the above, the researchers judged patients who are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Global longitudinal strain rate of left ventricle;

Secondary

MeasureTime frame
Other variable measured by 2D-STE;HbA1c;fasting blood sugar;HOMA-IR;Biochemical analysis;Blood pressure;

Countries

China

Contacts

Public ContactZhu Dalong

The Affiliated Drum Tower Hospital of Nanjing University Medical School

zhudalong@nju.edu.cn+86 13805150781

Outcome results

None listed

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