Diabetes drug may fight heart scarring in High-Risk patients
NCT ID NCT05367063
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study tested whether canagliflozin, a diabetes drug, can reduce scarring in the heart muscle of people with type 2 diabetes who are at high risk for heart problems. 45 participants were randomly assigned to take either canagliflozin or sitagliptin daily. Researchers used MRI scans to measure changes in heart fibrosis over time, aiming to understand how the drug might protect the heart.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Canagliflozin (a diabetes drug) compared to sitagliptin
- What this could lead to
- If it works, this could show that canagliflozin helps reduce heart scarring, potentially lowering heart failure risk in people with diabetes.
- What could go wrong
- This is a small, early-phase study with only 45 participants, so results may not apply broadly. The effect on heart scarring is uncertain, and the drug may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
45 people
The number who actually took part.
- Started
-
Jan 2022
- Finished
-
Mar 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. 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; 2. 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 Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cardiovascular risk are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can mindfulness and yoga rewire diabetes habits?
- Can a vegan diet delivered online help people with type 2 diabetes?
- Tiny horses, big lessons: can ponies help kids tame diabetes?
- Gut microbes in pregnancy and infancy: a window into lifelong health?
- A blood test at 50 could flag your risk of five diseases. can an app stop them?
- Chatbot coach takes aim at diabetes risk after pregnancy