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Study of semaglutide and dapagliflozin effects on heart muscle insulin resistance in patients with type 2 diabetes

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What is this trial about?

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

This study examines type 2 diabetes and focuses on understanding a condition called insulin resistance in the heart muscle. Insulin resistance means the body's cells do not respond properly to insulin, a hormone that helps control blood sugar levels. When this happens in the heart, it may affect how well the heart works and how blood flows through the heart's blood vessels. The study looks at whether this problem in the heart muscle increases the risk of heart-related complications and a specific heart condition called diabetic cardiomyopathy, which is when diabetes causes damage to the heart muscle.

The study will test two different medications to see how they affect insulin resistance in the heart. The first medication is semaglutide, which is given as an injection under the skin and belongs to a group of medicines called GLP-1RA. The second medication is dapagliflozin propanediol, which is taken by mouth as a tablet and belongs to a group of medicines called SGLT2i. Both of these medications are already used to treat type 2 diabetes, but this study wants to learn more about how they work specifically on the heart muscle.

During the study, participants will receive one of these medications for a period of 16 weeks. The researchers will use special imaging tests to look at the heart and measure how well it uses sugar for energy and how blood flows through the heart. These tests include 18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT, which are imaging techniques that create detailed pictures of the heart. The purpose of the study is to understand whether insulin resistance in the heart affects heart function and blood flow in the coronary arteries, and to see if the two medications can improve these problems in people with type 2 diabetes.

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

    Initial assessment and baseline measurements

    Upon entering the study, your baseline health status will be documented. This includes measurements of your body mass index, which is a calculation based on your height and weight.

    Your HbA1c level will be checked. This is a blood test that shows your average blood sugar levels over the past 2-3 months.

    Baseline imaging tests will be performed using 18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT. These are specialized scans that create images of your heart to assess how well it uses sugar for energy and how blood flows through your heart muscle.

  2. Step 2

    Treatment with semaglutide injection

    You will receive semaglutide, which is sold under the brand name Ozempic. This medication comes as a solution for injection in a pre-filled pen.

    The dose is 1 mg, and you will inject it under the skin (subcutaneously).

    This medication is a GLP-1 receptor agonist, which means it helps your body produce more insulin when your blood sugar is high and slows down digestion.

    The specific frequency of injections and duration of treatment will be determined according to the study protocol.

  3. Step 3

    Treatment with dapagliflozin tablets

    You will take dapagliflozin tablets by mouth. These are film-coated tablets.

    The dose is 10 mg per tablet.

    This medication is an SGLT2 inhibitor, which works by helping your kidneys remove sugar from your body through urine.

    The specific timing of when to take the tablets and the duration of treatment will be determined according to the study protocol.

  4. Step 4

    Monitoring and follow-up assessments

    Throughout the study, your response to the treatments will be monitored.

    Follow-up imaging tests using 18F-FDG PET/CT and 99mTc-Tetrofosmin SPECT will be performed to evaluate changes in how your heart muscle uses insulin and how blood flows through your coronary arteries.

    Your heart function will be assessed to determine if the treatments have any effect on how well your heart works.

    Regular measurements will be taken to track your progress during the treatment period.

  5. Step 5

    Final evaluation

    At the end of the study, final assessments will be completed.

    These will include the same types of imaging tests and measurements that were done at the beginning to compare the results.

    The study is expected to continue until July 2027, though your individual participation duration may vary according to the study design.

Who can join the trial?

7 criteria

  • You must have Type 2 diabetes, which is a condition where your body does not use insulin properly, leading to high blood sugar levels
  • Your BMI (Body Mass Index, a measure of body fat based on height and weight) should be around 30 kg/m2
  • Your HbA1c (a blood test that shows your average blood sugar level over the past 2 to 3 months) must be between 7 and 9 percent
  • You must not smoke
  • You must not drink alcohol
  • You must be an adult
  • Both men and women can participate in this study

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria have been provided for this clinical trial in the available information.
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Investigated drugs

  • GLP-1RA

    is a type of diabetes medication that helps your body produce more insulin when your blood sugar is high. It also slows down how quickly food leaves your stomach and can help with weight loss. This medication is given as an injection under the skin.

  • SGLT2i

    is a diabetes medication that works by helping your kidneys remove extra sugar from your body through urine. This medication is taken as a pill and can also help lower blood pressure and protect your heart and kidneys.

What is already known about the treatment

  • GLP-1RA (Glucagon-Like Peptide-1 Receptor Agonist)

    This medication is given as an injection under the skin, typically once daily or once weekly depending on the specific product. It is an approved and widely used treatment for type 2 diabetes that helps control blood sugar levels by mimicking a natural hormone in the body. GLP-1RA works by stimulating insulin release from the pancreas when blood sugar is high, slowing down digestion, and reducing appetite. This medication belongs to a class called incretin mimetics and is being studied in this trial to understand how it affects insulin resistance in the heart muscle.

  • SGLT2i (Sodium-Glucose Cotransporter-2 Inhibitor)

    This medication is taken by mouth as a tablet, usually once daily with or without food. It is an established treatment option for type 2 diabetes that has been approved for use in many countries. SGLT2i works by blocking a protein in the kidneys that normally reabsorbs sugar back into the blood, causing excess sugar to be removed from the body through urine instead. This drug class is being investigated in this clinical trial to evaluate its effects on insulin resistance in heart tissue and its potential benefits for heart function in diabetic patients.

Investigated diseases

  • Type 2 Diabetes

    A chronic condition that affects the way the body processes blood sugar, also known as glucose. The body either resists the effects of insulin, which is a hormone that regulates the movement of sugar into cells, or does not produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can damage various organs and systems in the body. The condition often develops gradually, with symptoms that may include increased thirst, frequent urination, hunger, fatigue, and blurred vision. It is commonly associated with being overweight and physical inactivity. The disease can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys.

  • Diabetic Cardiomyopathy

    A disorder of the heart muscle that develops in people with diabetes, occurring independently of coronary artery disease or high blood pressure. The condition causes structural and functional changes in the heart, including thickening and stiffening of the heart muscle. As the disease progresses, the heart becomes less able to pump blood effectively throughout the body. This leads to reduced heart function and can cause symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The condition develops gradually over time as a result of prolonged exposure to high blood sugar levels. It represents a specific form of heart muscle disease related to metabolic changes caused by diabetes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523374-17-01Protocol codePI24/01356Estimated enrolment60 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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