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Diabetes drug may fight heart scarring in High-Risk patients

NCT ID NCT05367063

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.