A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
This research study is investigating a medication called tirzepatide for adults who have type 2 diabetes. Researchers want to find out how effective and safe tirzepatide is, especially when people start taking it early on in their treatment journey, compared to other usual diabetes treatments. The study aims to improve blood sugar control and overall health for people with type 2 diabetes. This is a "Phase 4" study, meaning the treatment has already been approved for use, but doctors want to learn more about how it works in real-world settings and against other common treatments. Participants will receive either tirzepatide or intensified usual care, with regular check-ups to monitor their progress and safety.
At a glance
What is this study about?
This study is for adults with type 2 diabetes. It's looking at a new treatment called tirzepatide. Many people with type 2 diabetes might already be taking metformin, a common medicine for this condition. This study wants to see if adding tirzepatide, or using it alongside or instead of other treatments, works better than continuing with or intensifying standard care.
The main aim is to understand how well tirzepatide controls blood sugar and if it's safe when it's started relatively early in the treatment of type 2 diabetes. By comparing it to existing treatments, doctors hope to find even more effective ways to manage type 2 diabetes and improve people's health. This is important because good blood sugar control can help prevent complications from diabetes.
This kind of study, called a Phase 4 study, usually happens after a medicine has already been approved for public use. It helps doctors learn more about how the medicine works in a broader group of people and in comparison to other established treatments. Your health will be carefully monitored throughout the study to make sure any treatment you receive is safe and appropriate for you.
Key takeaways
- This study is for adults with type 2 diabetes.
- It compares tirzepatide to other standard diabetes treatments.
- It aims to see how well tirzepatide controls blood sugar and if it's safe.
- You would receive close medical attention throughout the study.
- Participation is voluntary, and you can leave at any time.
- This is a Phase 4 study, meaning the medicine is already approved.
Who may be eligible?
To join this study, you need to be an adult with type 2 diabetes, diagnosed within the last four years. Your diabetes should be moderately controlled, meaning your HbA1c (a measure of your average blood sugar over 2-3 months) needs to be between 7% and 9.5%. You should also have been taking only metformin, a common diabetes medicine, for at least three months, at a stable dose.
There are certain reasons why you might not be able to join. For example, if you have type 1 diabetes, or a history of certain serious conditions like chronic pancreatitis, some advanced eye conditions related to diabetes, or a high risk of heart problems like a recent heart attack or stroke. Also, if you have a family history of specific thyroid cancers, or if your kidneys aren't working well enough, you wouldn't be able to take part.
If you've recently taken medicines to help with weight loss, or have previously used certain injectable diabetes medicines called GLP-1 receptor agonists or insulin, you also wouldn't be eligible. The main idea is to study tirzepatide in people who are relatively new to diabetes treatment and don't have other complex health issues that might affect the study results.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult (18 or older)?
- Were you diagnosed with type 2 diabetes within the last 4 years?
- Is your HbA1c (average blood sugar) between 7% and 9.5%?
- Are you currently only taking metformin for your diabetes, at a stable dose for at least 3 months?
- Do you have good kidney function?
- Do you NOT have a history of serious heart problems or pancreatitis?
What does participation involve?
If you decide to take part in this study, you would be given either tirzepatide or an intensified version of your usual diabetes treatment. You would have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. These visits might happen quite often at the beginning and then become less frequent as the study progresses. The total duration of the study would be explained to you in detail by the study team. You would also receive support and guidance from the research team throughout your participation.
Potential risks and benefits
Locations (90)
- Cahaba Research - TrussvilleVerified postcodeBirmingham, United States
- San Fernando Valley Health InstituteVerified postcodeCanoga Park, United States
- Velocity Clinical Research, Huntington ParkVerified postcodeHuntington Park, United States
- Velocity Clinical Research, San DiegoVerified postcodeLa Mesa, United States
- Clinical Trials ResearchVerified postcodeLincoln, United States
- Velocity Clinical Research, WestlakeVerified postcodeLos Angeles, United States
- Catalina Research Institute, LLCVerified postcodeMontclair, United States
- Velocity Clinical Research, North HollywoodVerified postcodeNorth Hollywood, United States
- Velocity Clinical Research, Panorama CityVerified postcodePanorama City, United States
- Western University of Health SciencesVerified postcodePomona, United States
- Velocity Clinical Research, Santa AnaVerified postcodeSanta Ana, United States
- New England Research Associates, LLCVerified postcodeBridgeport, United States
Common questions
What is tirzepatide?
Tirzepatide is a medicine for type 2 diabetes that helps control blood sugar. This study is looking at it more closely.
How long will the study last?
The exact length of your participation will be discussed with you by the study team, but generally these kinds of studies can last for a year or more.
Will I have to pay for the medication?
No, all study-related medication and procedures are provided at no cost if you participate in the trial.
What if I feel unwell during the study?
You will have regular contact with the study team, and you should tell them immediately if you experience any new symptoms or feel unwell.
Will I be given a placebo?
You will receive either tirzepatide or an intensified form of standard diabetes care; you will not receive a placebo (dummy treatment) in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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