Status:
COMPLETED
Canagliflozin and Myocardial Fibrosis
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Type 2 Diabetes
Cardiovascular Risk
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Recently, large clinical intervention studies have demonstrated the cardiovascular protective effects on of sodium-glucose cotransporter 2 inhibitors (SGLT2i) such as empagliflozin, dapagliflozin, and...
Detailed Description
According to the International Federation for Diabetes, diabetes now affects approximately 9.3% of the population worldwide, and the prevalence over the next two decades will continue to increase, rea...
Eligibility Criteria
Inclusion
- History of type 2 diabetes;
- Haemoglobin A1c ≥7.0% and \< 10.5%;
- Patients who have received a stable dose of metformin or metformin combined with insulin secretagogues and/or insulin therapy for 4 weeks before enrollment;
- Those who met at leat one of the following criteria:
- Patients with at least 3 of the folllowing risk factors: (1) male \>55 years old, or female \> 65 years old; (2) BMI≥25 kg/m2; (3) hypertension; (4) dyslipidemia; (5) current smoker (Brinkman index ≥ 200;
- Any of the following signs of target organ damage are present: (1) albuminuria (ACR≥300mg/g); (2) 45 ml/min/1.73 m2 ≤eGFR\<90 ml/ min/1.73 m2; (3) Left ventricular hypertrophy or coupled with retinopathy.
Exclusion
- Female subjects who are pregnant, lactating or of child bearing potential, or pre-menopausal women. (Menopause will be determined by patient and physician history;
- Subjects currently treated with SGLT2 inhibitors, GLP1 receptor agonist, or sitagliptin;
- Significant allergy or known intolerance to Canagliflozin or Sitagliptin;
- History of hypovolemia, amputation, peripheral vascular disease, diabetic foot ulcers;
- History of diagnosed cardiovascular diseases, including myocardial infarction, hospitalization for unstable angina pectoris, cerebral infarction (ischemic stroke), coronary artery bypass grafting, percutaneous coronary intervention (with or without stents) Implantation), peripheral vascular reconstruction (angioplasty or surgery), heart failure, arrhythmia, heart valve disease;
- AST or ALT ≥ 3 times the upper limit of normal;
- eGFR \<45 ml/min/1.73 m2；
- type 1 diabetes;
- Diabetic ketosis or diabetic hyperosmolar coma;
- History of respiratory disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension, etc.);
- Existing hypertensive emergency (systolic/diastolic blood pressure exceeding 180/120mmHg) at the time of enrollment, or evaluated For refractory hypertension (after the use of sufficient doses of 3 antihypertensive drugs, the systolic blood pressure is still\> 140 or Diastolic blood pressure\> 90mmHg);
- Known 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, malabsorption related diseases, and non-absorbent diseases. Controlled diarrhea, gastrointestinal surgery (such as bariatric surgery);
- Patients with diagnosed malignant tumors;
- Participate in other clinical trials within 3 months;
- Other creteria that were not eligible to participate in the clinical trial.
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05367063
Start Date
January 5 2022
End Date
March 20 2025
Last Update
December 16 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000