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Effect of dapagliflozin and semaglutide on heart insulin resistance in type 2 diabetes patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people with type 2 diabetes and compares two medicines: a tablet that contains dapagliflozin, which belongs to a group called SGLT2i and is taken by mouth, and an injection pen that delivers semaglutide, a drug that works as a GLP-1RA. The purpose of the study is to find out whether these medicines can improve the way the heart works in patients who have insulin resistance in the heart muscle, a condition where the heart cells do not respond well to insulin.

Participants will take the assigned medication for a set period and will undergo special heart scans. One scan uses PET/CT, a technique that shows how the heart uses sugar, and it involves a tiny amount of a substance called 18F-FDG. Another scan, called SPECT, uses a different tiny amount of a substance named 99mTc-Tetrofosmin to look at blood flow in the heart. These images will be used to measure myocardial insulin resistance, coronary flow and overall heart function. After the scans, participants will have regular check‑ins to monitor how they feel and to ensure safety until the final follow‑up visit.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment confirmation

    After joining the study, the patient receives written confirmation of enrollment.

    The patient undergoes initial assessments that include a review of medical history, blood tests, and two imaging procedures: 18f-fdg pet/ct to evaluate heart tissue metabolism and 99mtc-tetrofosmin spect to assess heart blood flow.

  2. Step 2

    Start of study medication

    The patient begins taking the comparator medication dapagliflozin as an oral tablet.

    Dose: 10 mg (ten milligrams) taken once each day.

    The patient also starts the test medication semaglutide administered by subcutaneous injection using a pre‑filled pen.

    Dose: 1 mg (one milligram) injected once each week.

    Both medications are continued for the entire duration of the trial, which runs until the estimated end date of 2027-09-30.

  3. Step 3

    Regular follow‑up visits

    The patient attends scheduled clinic visits, typically every four weeks, for safety monitoring.

    At each visit, vital signs are recorded, adverse events are reviewed, and blood samples are taken to monitor glucose control and kidney function.

    The patient receives reminders of the medication dosing schedule and any necessary adjustments are documented.

  4. Step 4

    Interim imaging assessments

    At predetermined intervals during the trial, the patient undergoes repeat 18f-fdg pet/ct and 99mtc-tetrofosmin spect scans.

    These scans are used to evaluate changes in myocardial insulin resistance, coronary flow, and heart function over time.

  5. Step 5

    Final study assessments

    At the conclusion of the trial, the patient completes a final set of evaluations.

    This includes the last round of blood tests and the final 18f-fdg pet/ct and 99mtc-tetrofosmin spect imaging sessions.

    The collected data are used to determine the primary outcome of myocardial insulin resistance and the secondary outcomes of coronary flow and heart function.

Who can join the trial?

6 criteria

  • Your body mass index (BMI) should be around 30 kg/m², which means your weight is about average for your height.
  • You must have Type 2 diabetes (DM2), a condition where the body does not use insulin properly.
  • You should not be currently smoking cigarettes or drinking alcohol.
  • Your HbA1c level—a blood test that shows your average blood‑sugar control over the past 2‑3 months—must be between 7 % and 9 %.
  • You can be either male or female.
  • You need to be within the adult age range specified by the study.

Who cannot join the trial?

4 criteria

  • Having had a previous cardiovascular disease (CVD) event, such as a heart attack or stroke.
  • Having serious problems with the liver (hepatic) or the kidneys.
  • Being very afraid of the small, enclosed space needed for the heart imaging scans called PET/CT and SPECT (a type of claustrophobia).
  • Currently taking diabetes medicines known as SGLT2 inhibitors or GLP‑1 analogs.
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Investigated drugs

  • Dapagliflozin

    is a pill taken by mouth that helps the kidneys get rid of extra sugar in the urine. In this study it is used as the standard treatment to compare the new therapy against. By lowering blood sugar, it may also influence how the heart muscle works in people with type 2 diabetes.

  • Semaglutide

    is a medication given as an injection under the skin. It belongs to a class of drugs that mimic a natural hormone called GLP‑1, which helps lower blood sugar by increasing insulin release and reducing appetite. In this trial it is the new treatment being tested to see if it can improve heart muscle function and blood flow in patients with type 2 diabetes.

What is already known about the treatment

  • Dapagliflozin 10 mg film-coated tablets

    This medication is taken by mouth as a film‑coated tablet. It is an approved and widely used drug for treating type 2 diabetes and is listed in many medical guidelines. Dapagliflozin works by blocking a protein in the kidneys called SGLT2, which reduces the re‑absorption of glucose and lets excess sugar leave the body in urine. It belongs to the class of SGLT2 inhibitors, a type of glucose‑lowering medicine.

  • Ozempic 1 mg solution for injection in pre‑filled pen

    This drug is given as a subcutaneous injection using a pre‑filled pen. It is an approved treatment for type 2 diabetes (and also for weight management) and is described in current medical literature as a GLP‑1 receptor agonist. Semaglutide mimics the natural hormone GLP‑1, helping the pancreas release more insulin after meals, slowing stomach emptying, and reducing appetite. It is classified as a GLP‑1 receptor agonist, a class of medicines that improve blood sugar control.

Investigated diseases

  • Type 2 diabetes mellitus

    A chronic condition where the body does not use insulin well and blood sugar stays high. It develops gradually, often starting with a mild rise in blood sugar. Over time, the pancreas may produce less insulin. High sugar can affect many organs. The condition usually appears in adulthood.

  • Diabetic cardiomyopathy

    A disorder of the heart muscle that occurs in people with diabetes, independent of blood‑vessel disease. The heart muscle becomes stiff and may not pump efficiently. This change develops slowly as diabetes persists. Symptoms can include shortness of breath and reduced exercise capacity. It is linked to the metabolic changes caused by diabetes.

  • Myocardial insulin resistance

    A state where heart‑muscle cells respond poorly to insulin, reducing their ability to take up glucose. This resistance can develop in people with diabetes or metabolic problems. It may lead to changes in heart energy use and affect how the heart contracts. Over time, it can contribute to reduced heart function. It is studied as a factor that may influence heart health.

  • Cardiovascular disease

    A group of disorders affecting the heart and blood vessels, such as blockages or weakened vessels. These conditions often develop slowly as plaque builds up or vessels become damaged. They can reduce blood flow to the heart and other organs. Symptoms may include chest discomfort or fatigue. The disease risk increases with factors like high blood sugar, high blood pressure, and smoking.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523374-17-03Protocol codePI24/01356Estimated enrolment60 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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