Study on Switching from Dulaglutide to Tirzepatide for Adults with Type 2 Diabetes

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What is this study about?

This clinical trial is focused on studying the effects of switching medications in adults with Type 2 Diabetes. The study involves two medications: Dulaglutide and Tirzepatide. Dulaglutide is a medication that is currently used once a week to help manage blood sugar levels in people with Type 2 Diabetes. The study aims to investigate whether switching from weekly Dulaglutide to weekly Tirzepatide is more effective in controlling blood sugar levels, specifically looking at changes in Hemoglobin A1c (HbA1c), which is a measure of average blood sugar over the past two to three months.

Participants in the study will be adults who have been using Dulaglutide for at least six months. The study will last for 40 weeks, during which participants will either continue with Dulaglutide or switch to Tirzepatide. The main goal is to see if Tirzepatide can better reduce HbA1c levels compared to continuing with Dulaglutide. Additionally, the study will look at other factors such as changes in weight, waist circumference, and body mass index (BMI), as well as the impact on quality of life related to weight.

The study will also assess the percentage of participants who achieve specific targets, such as an HbA1c level below 7% and weight loss of 5% or more from the start of the study. By comparing these outcomes, the study aims to provide insights into the potential benefits of switching to Tirzepatide for better management of Type 2 Diabetes.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the trial. You will be asked to provide consent to participate.

You will be assessed to ensure you meet the criteria for participation, such as having type 2 diabetes and a specific range of HbA1c levels.

2 initial assessment

An initial assessment will be conducted to record your baseline health data. This includes measuring your Hemoglobin A1c (HbA1c), weight, and other relevant health indicators.

You will continue your current medication, dulaglutide, which is administered once weekly by injection.

3 randomization

You will be randomly assigned to one of two groups: one group will switch to tirzepatide, and the other will continue with dulaglutide.

Both medications are administered once weekly by injection.

4 treatment phase

If you are in the tirzepatide group, you will start receiving tirzepatide injections once a week. The dosage may be adjusted based on your response to the medication.

If you remain in the dulaglutide group, you will continue with your current weekly injections, with possible dosage adjustments.

5 regular monitoring

Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. This includes measuring your HbA1c, weight, and other health indicators.

You will be asked to report any side effects or changes in your health.

6 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the changes in your health indicators, such as HbA1c and weight.

The results will help determine the effectiveness and safety of switching from dulaglutide to tirzepatide.

Who Can Join the Study?

Have Type 2 Diabetes.
Have an HbA1c level between 7.0% (53 mmol/mol) and 9.5% (80 mmol/mol). HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months.
Currently taking a stable dose of dulaglutide once a week (0.75 mg or 1.5 mg) for at least 6 months before joining the study. Dulaglutide is a medication used to treat Type 2 Diabetes.
Not taking any oral diabetes medications, or taking a stable dose of up to 3 oral diabetes medications, such as metformin, SGLT-2 inhibitors, and/or sulfonylurea, for at least 3 months before joining the study. These are different types of medications used to manage blood sugar levels.
Have a stable body weight (within 5% change) during the 90 days before joining the study.
Have a Body Mass Index (BMI) of 25 or higher. BMI is a measure of body fat based on your weight in relation to your height.

Who Cannot Join the Study?

Patients who do not have Type 2 Diabetes cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia	Baia Mare	Romania

Other Sites

Site Name	City	Country
Gama Diamed S.R.L.	Mangalia	Romania
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
InnoDiab Forschung GmbH	Essen	Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH	Oldenburg In Holstein	Germany
Clinica Korall S.R.L.	Satu Mare	Romania
Vitaz	Sint-Niklaas	Belgium
Centre De Recherche Clinique Portes Du Sud	Venissieux	France
Algemeen Ziekenhuis Damiaan Oostende	Ostend	Belgium
Mariodiab Clinic S.R.L.	Brasov	Romania
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR	Berlin	Germany
Diabdana S.R.L.	Oradea	Romania
ZNA Jan Palfijn	Antwerp	Belgium
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Askevlqjbs Prtdylbt Hmkbrvlw Dx Mppeifsfl	Marseille	France
Ekliroqi Suhbwy	Bucharest	Romania
Ugkudtmlgd Oe Aieipcn	Edegem	Belgium
Idqnby	Bonheiden	Belgium
Poyftihhmssdh Dr Ulqlrl Wvpkfuov Di Dngevcq Dnmd Uld Ppmf Dy Jglv Azksmp	Hamburg	Germany
Gvf Gfkuer hbzzncburpl Pfqgb Skeklmfemecr	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	03.02.2023
France	Not yet recruiting	03.02.2023
Germany	Not recruiting	03.02.2023
Romania	Not recruiting	03.02.2023

Trial locations

Investigated drugs:

Dulaglutide is a medication used to help manage blood sugar levels in adults with type 2 diabetes. It is taken once a week and works by helping the body release more insulin after meals, which helps lower blood sugar levels. This medication is often used when diet and exercise alone are not enough to control diabetes.

Tirzepatide is another medication used for managing blood sugar in adults with type 2 diabetes. Like dulaglutide, it is also taken once a week. Tirzepatide helps the body control blood sugar by increasing insulin production and reducing the amount of sugar the liver makes. It is being studied to see if it is more effective than dulaglutide in lowering blood sugar levels over time.

Investigated diseases:

Type 2 diabetes mellitus

Type 2 Diabetes – Type 2 Diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body’s cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the condition progresses, it may lead to more severe health issues if not managed properly.

Trial ID:

2022-500101-41-00

Protocol code:

I8F-MC-GPIH

NCT ID:

NCT05564039

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Switching from Dulaglutide to Tirzepatide for Adults with Type 2 Diabetes

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