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Study on the Effect of Semaglutide in Patients with Type 1 Diabetes and Insulin Resistance

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Ozempic, which contains the active substance semaglutide. The study is specifically looking at patients with a condition known as type 1 diabetes who also have characteristics of type 2 diabetes, a situation sometimes referred to as "double diabetes." The purpose of the study is to observe how adding semaglutide to the standard treatment affects the amount of time patients' blood sugar levels stay within a healthy range over a period of six months.

Participants in the study will receive Ozempic as a solution for injection, which is administered using a pre-filled pen. The study will compare different doses of Ozempic (0.25 mg, 0.5 mg, and 1 mg) to see how they influence blood sugar control. Some participants may receive a placebo, which is a treatment that looks like the real medication but does not contain the active substance. The study will last for about six months, during which time participants will be monitored to see how their blood sugar levels change.

Throughout the study, researchers will also look at other factors such as changes in body weight, waist size, and the amount of insulin needed daily. They will use devices that continuously monitor blood sugar levels to gather detailed information. The study aims to provide insights into how semaglutide can help manage blood sugar levels in people with "double diabetes" and improve their overall health. The study is expected to conclude in 2026.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written consent to participate.

    Women of childbearing age must use effective contraception during the study and for up to 2 months after the end of treatment.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, including verification of type 1 diabetes diagnosis and other criteria such as age, BMI, and family history.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with semaglutide, administered as a subcutaneous injection once a week.

    The available dosages are 0.25 mg, 0.5 mg, and 1 mg, provided in pre-filled pens.

  4. Step 4

    Treatment duration

    The treatment with semaglutide will continue for a period of 6 months.

    During this time, the patient will continue their optimized insulin therapy.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the patient will use a continuous glucose monitoring system, such as Guardian, Dexcom, or Free Style Libre, to track glucose levels.

    Regular assessments will be conducted to measure the percentage of time spent within the glycemic target range (0.70-1.80 g/l), HbA1c levels, weight, waist circumference, and daily insulin dose.

  6. Step 6

    End of treatment evaluation

    At the end of the 6-month treatment period, a final evaluation will be conducted to assess changes in the patient's condition, including glycemic control and any adverse events experienced during the study.

Who can join the trial?

13 criteria

  • Person who has provided written consent.
  • For women of childbearing age, effective contraception is required for up to 2 months after the end of treatment. Effective contraception includes methods like hormonal contraception, an intrauterine device, blocking of the fallopian tubes, vasectomy, and choosing not to have sex.
  • Patient must be over 18 years of age.
  • Patient with **Type 1 diabetes** confirmed by a **C-peptide** level below laboratory standards. **C-peptide** is a substance made in the pancreas, and low levels can indicate Type 1 diabetes.
  • Age at diagnosis must be less than 35 years.
  • Patient must have been treated with optimized insulin therapy, which means using multiple injections or an insulin pump, for at least 1 year. They should have received specific education on how to adjust insulin doses.
  • **BMI** (Body Mass Index) must be 27 kg/m² or higher. **BMI** is a measure of body fat based on height and weight.
  • Patient must meet at least one of the following criteria:
    • Family history of **Type 2 diabetes** (in parents, grandparents, uncles, aunts, siblings).
    • Family history of obesity, with a **BMI** over 30 kg/m² (in parents, grandparents, uncles, aunts, brothers, and sisters).
    • **Triglycerides** level greater than 1.50 g/l (1.7 mmol/l). **Triglycerides** are a type of fat found in the blood.
    • **HDL** (good cholesterol) less than 0.5 g/l (1.29 mmol/l) in women, or less than 0.4 g/l (1.03 mmol/l) in men.
    • **HbA1c** level must be 7.5% or higher and less than 12% in the 3 months before joining the study. **HbA1c** is a blood test that shows average blood sugar levels over the past 2 to 3 months.
    • Patient must use continuous glucose monitoring with a **CGM** (Continuous Glucose Monitoring) system like Guardian, Dexcom, or Free Style Libre. These devices help track blood sugar levels continuously.

Who cannot join the trial?

6 criteria

  • Patients who do not have **type 1 diabetes** with **"double diabetes"** cannot participate. **Double diabetes** refers to having type 1 diabetes along with some characteristics of type 2 diabetes.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who are pregnant or planning to become pregnant during the study cannot participate.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate cannot join the study.
  • Patients who are currently participating in another clinical trial cannot participate in this study.
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Investigated drugs

Semaglutide is a medication used in this clinical trial to help manage blood sugar levels in patients with type 1 diabetes who also have characteristics of type 2 diabetes, a condition sometimes referred to as "double diabetes." The trial aims to see how adding semaglutide to the standard treatment affects the amount of time patients' blood sugar levels stay within a target range over six months.

What is already known about the treatment

Semaglutide – Semaglutide is administered as a weekly injection under the skin. It is currently being studied in clinical trials for its effects on individuals with "double diabetes," which refers to type 1 diabetes patients who also exhibit characteristics of type 2 diabetes. The main therapeutic indication for semaglutide in this context is to improve blood sugar control by increasing the time spent within the target glucose range. At the molecular level, semaglutide works by mimicking a natural hormone called GLP-1, which helps to regulate insulin secretion and reduce blood sugar levels. It is classified as a GLP-1 receptor agonist in pharmacology.

Investigated diseases

Double Diabetes – Double diabetes is a condition where an individual with type 1 diabetes also exhibits characteristics of type 2 diabetes, such as insulin resistance. This condition can occur when a person with type 1 diabetes gains weight or develops other risk factors associated with type 2 diabetes. The progression involves managing both the autoimmune aspect of type 1 diabetes and the metabolic issues seen in type 2 diabetes. Patients may experience fluctuations in blood sugar levels and require adjustments in their insulin therapy. The condition can complicate the management of diabetes, as it involves addressing both insulin deficiency and resistance. Monitoring and lifestyle changes are often necessary to maintain blood glucose levels within the target range.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514906-30-00Protocol codeTOLEDDOEstimated enrolment76 patientsSponsorCentre Hospitalier Universitaire De Dijon

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