Not yet recruiting

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 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.

The research process

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

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

3 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
Baia Mare, Romania
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruitingNot recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Dulaglutide
Dulaglutide is a medication administered through a weekly injection under the skin, commonly used to help manage blood sugar levels in adults with Type 2 Diabetes. It is well-established in medical practice and literature as an effective treatment for this condition. The main therapeutic indication for dulaglutide is to improve blood sugar control in people with Type 2 Diabetes. At the molecular level, it works by mimicking a hormone in the body that helps regulate insulin, which lowers blood sugar levels. Dulaglutide is classified as a glucagon-like peptide-1 (GLP-1) receptor agonist.
Tirzepatide
Tirzepatide is also administered as a weekly injection under the skin and is being studied for its potential to manage blood sugar levels in adults with Type 2 Diabetes. It is currently being evaluated in clinical trials to determine its effectiveness and safety compared to other treatments like dulaglutide. The main therapeutic indication for tirzepatide is to improve blood sugar control in people with Type 2 Diabetes. It works by activating receptors for two hormones that help regulate insulin and blood sugar levels. Tirzepatide is classified as a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist.

Investigated diseases

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.