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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Centre Hospitalier Regional Universitaire	Besançon	France
Assistance Publique Hopitaux De Paris	Paris	France
Czbuzw Hmxqcmtlsfc de Mtaqp	Macon	France
Cz Gpxk Vulkjd	Vesoul	France
Cdmyyz Hbdfyybvmmd Utxzllnallfqe Di Dslwx	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Semaglutide

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.

Investigated diseases:

Diabetes mellitus

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 ID:

2024-514906-30-00

Protocol code:

TOLEDDO

NCT ID:

NCT05305794

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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