J2A-MC-GZGW: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared with Placebo in Adult Participants with Type 2 Diabetes and Inadequate Glycemic Control with Insulin Glargine, with or without Metformin and/or SGLT-2 Inhibitor (ACHIEVE-5)
This important study, called ACHIEVE-5, is testing a new daily tablet called orforglipron. It's for adults in the UK who have type 2 diabetes and whose blood sugar isn't well controlled, even though they're already taking insulin glargine. Some participants might also be on metformin or a type of medicine called an SGLT-2 inhibitor (like empagliflozin or dapagliflozin). We want to find out if orforglipron is better than a dummy pill (placebo) at helping to manage blood sugar levels and if it's safe to use. This is a "Phase 3" study, which means it's one of the last steps before a new medicine might become widely available.
At a glance
What is this study about?
Imagine you have type 2 diabetes and your doctor has prescribed insulin glargine to help control your blood sugar. Even with this, and possibly other medicines like metformin or SGLT-2 inhibitors (such as empagliflozin or dapagliflozin), your blood sugar levels might still be higher than they should be. This study is for people like you.
Researchers are investigating a new tablet called orforglipron. They want to see if adding this new daily medicine to your current treatment can help bring your blood sugar closer to a healthy range. They will compare it to a dummy pill (called a placebo) to make sure any improvements are truly due to orforglipron and not just other factors.
This kind of study is called a 'Phase 3' trial. This means a lot of careful testing has already happened, and now they need to gather more information on a larger group of people. The main goal is to check if orforglipron is effective at controlling blood sugar and to carefully monitor its safety when used alongside other common diabetes treatments.
Key takeaways
- This study is testing a new daily tablet for type 2 diabetes.
- It's for adults whose blood sugar isn't fully controlled with existing treatments like insulin glargine.
- The new medicine is called orforglipron and is compared to a dummy pill.
- The main goals are to check how well it works and if it's safe.
- Participation involves regular clinic visits and health monitoring.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adult men and women, aged 18 or older, who have type 2 diabetes. You would need to be currently taking insulin glargine to help manage your diabetes. You might also be taking metformin or another type of diabetes medicine called an SGLT-2 inhibitor (like empagliflozin or dapagliflozin).
You should have blood sugar levels that are not quite where your doctor wants them to be, despite your current treatment. The study team will check your recent blood test results to confirm this.
There will be specific health checks and other requirements to make sure the study is safe and right for you. If you're interested, the study team will go through all the details to see if you meet all the necessary criteria.
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 18 years old or older?
- Do you have type 2 diabetes?
- Are you currently taking insulin glargine?
- Is your blood sugar still not as well-controlled as your doctor would like?
- Are you able to attend regular appointments at a study clinic?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. This would involve a review of your medical history, a physical exam, and some blood tests. If you qualify, you will be randomly assigned to either receive the new medicine, orforglipron, or a dummy pill (placebo).
Throughout the study, you would have regular visits to the clinic. At these visits, the study team would monitor your health, check your blood sugar levels, and make sure you're taking your study medication correctly. These visits are also a chance for you to discuss any concerns or side effects you might be experiencing. The total duration of your participation in the study, including follow-up, will be explained in detail by the study staff.
Potential risks and benefits
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Common questions
What is a 'Phase 3' study?
A Phase 3 study is one of the final stages of testing a new medicine. It involves more people and aims to confirm how well it works and its safety before it might become widely available.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. This helps researchers understand if the new medicine is truly effective.
Will I know if I'm getting the new medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're taking orforglipron or the placebo. This helps ensure unbiased results.
Can I continue taking my other diabetes medicines?
Yes, this study is recruiting people who are already taking insulin glargine, and potentially metformin or an SGLT-2 inhibitor. The study will look at how orforglipron works alongside these existing treatments.
How long will the study last for me?
The total length of your participation, including regular visits and follow-up, will be clearly explained by the study team if you're considered for the trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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