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Comparison of dapagliflozin and oral semaglutide effectiveness in type 2 diabetes patients based on insulin resistance or secretion deficit

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

This clinical study focuses on Type 2 Diabetes, a condition where the body has difficulty controlling blood sugar levels. The study aims to examine how different diabetes medications work in patients who have different characteristics of the disease - either reduced insulin effectiveness or decreased insulin production by the body. The medications being studied are dapagliflozin, which helps remove excess sugar through urine, and semaglutide, which helps the body produce more insulin when blood sugar levels are high.

The study will use various substances naturally present in the body (called biomarkers) to determine which patients might respond better to which medication. These biomarkers include substances like adiponectin, irisin, and others that can indicate how well the body processes sugar. The study will also measure standard indicators of diabetes control such as HbA1c (a measure of average blood sugar levels over time).

Participants in the study will be taking either dapagliflozin tablets or semaglutide tablets while continuing their usual metformin treatment. Some patients may also receive insulin glargine, which is given by injection under the skin. The study will monitor how these different treatments affect blood sugar control and other body functions related to 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 medication phase

    You will continue taking metformin as your base medication, which you should have been using for at least 6 months before the trial

    Your blood sugar control will be measured through HbA1c test (a test that shows average blood sugar levels over the past 3 months)

    A blood test will check your C-peptide levels, which shows how much insulin your body produces

  2. Step 2

    Treatment assignment

    You will be assigned to receive either dapagliflozin (taken by mouth) or semaglutide (taken by mouth)

    These medications will be added to your current metformin treatment

  3. Step 3

    Monitoring and testing phase

    Regular blood tests will measure various substances in your blood including:

    - HbA1c (blood sugar control)

    - Glucagon (a hormone that affects blood sugar)

    - Insulin levels

    - Other blood proteins and substances that may affect diabetes

  4. Step 4

    Study duration

    The study will run from November 2024 to November 2026

    Your participation will help understand how different diabetes medications work for different types of patients

  5. Step 5

    Safety monitoring

    Regular check-ups will monitor your response to the medication

    Female participants must use approved birth control methods throughout the study period

    Pregnancy tests will be required for women who can become pregnant

Who can join the trial?

10 criteria

  • Must provide written informed consent before starting any study procedures
  • Must be willing and able to follow all study requirements
  • Age must be between 20 and 70 years
  • Open to both men and women
  • Must have been taking metformin (a diabetes medication) consistently for at least 6 months
  • Must have inadequate blood sugar control with HbA1c levels between 7.5% and 9% (HbA1c is a blood test that measures average blood sugar levels over the past 3 months)
  • Must have a fasting C-peptide level above 1 ng/mL (C-peptide is a substance that shows how much insulin your body produces)
  • Women who can become pregnant must have a negative pregnancy test at the first visit
  • Women who can become pregnant must agree to use approved birth control methods throughout the study
  • Must be able to take medications by mouth

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years
  • Current pregnancy or breastfeeding
  • History of type 1 diabetes (an autoimmune condition where the body does not produce insulin)
  • History of diabetic ketoacidosis (a serious complication where the body produces high levels of blood acids)
  • Severe kidney disease or kidney failure
  • Severe liver disease
  • History of pancreatitis (inflammation of the pancreas)
  • Active cancer or cancer treatment
  • Serious heart conditions or recent heart attack
  • History of severe allergic reactions to similar medications
  • Current participation in other clinical trials
  • Unable to follow study procedures or attend scheduled visits
  • History of alcohol or drug abuse within the past 12 months
  • Mental conditions that could interfere with study compliance
  • Taking medications that could interfere with the study drugs
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Investigated drugs

  • Dapagliflozin

    is a medication used to treat type 2 diabetes. It works by helping the kidneys remove excess sugar from the blood through urine. This medication belongs to a class of drugs called SGLT2 inhibitors, which help lower blood sugar levels in people with diabetes.

  • Semaglutide

    (oral form) is a medication taken by mouth to treat type 2 diabetes. It belongs to a class of medications called GLP-1 receptor agonists. This medicine helps control blood sugar levels by mimicking a natural hormone in your body. It helps your body release more insulin when blood sugar is high, reduces the amount of sugar your liver makes, and slows down food leaving your stomach.

What is already known about the treatment

  • Dapagliflozin

    An oral medication used to treat type 2 diabetes that belongs to the class of drugs called SGLT2 inhibitors. It works by helping the kidneys remove excess sugar from the blood through urination, which helps lower blood glucose levels. This medication is taken as a tablet once daily and has been proven effective in clinical trials for improving glycemic control while also providing cardiovascular benefits and potential weight loss effects.

  • Semaglutide

    An oral medication for type 2 diabetes that belongs to the GLP-1 receptor agonist class, mimicking the effects of natural incretin hormones in the body. It works by stimulating insulin production when blood sugar levels are high, reducing glucagon secretion, and slowing down digestion, which helps control blood glucose levels. This once-daily tablet has demonstrated significant effectiveness in blood sugar control and weight management through multiple clinical trials and is considered an advanced treatment option for type 2 diabetes.

Investigated diseases

Type 2 Diabetes - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition develops gradually, usually in adults, as the body becomes resistant to insulin or loses its ability to produce enough insulin. This form of diabetes often begins with insulin resistance, where fat, liver, and muscle cells do not respond properly to insulin. Over time, the pancreas may produce less insulin, leading to increased blood glucose levels. The condition is associated with being overweight, physical inactivity, and genetic factors. Type 2 diabetes can progress slowly and may be present for years before being noticed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516542-19-00Protocol codeBioPhenoT2DEstimated enrolment148 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

sourced from the EU Clinical Trials Register and site verification

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