J2A-MC-GZGV: A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared with Dapagliflozin in Adult Participants with Type 2 Diabetes and Inadequate Glycemic Control with Metformin (ACHIEVE-2)
This research study, called ACHIEVE-2, is testing a new medication called orforglipron for adults with type 2 diabetes. Participants in the study are already taking metformin, but their blood sugar levels are still too high. The study wants to find out if taking orforglipron once a day by mouth works better than, or as well as, an existing drug called dapagliflozin at lowering blood sugar. Researchers will also be checking if orforglipron is safe to use. This is a "Phase 3" study, which means it's one of the final steps to see if a new medicine should be approved for wider use. By comparing these two treatments, the study aims to improve care for people living with type 2 diabetes.
At a glance
What is this study about?
This study is looking into a new medication called orforglipron, which is designed to help people with type 2 diabetes manage their blood sugar levels. Many people with type 2 diabetes take a medication called metformin to help keep their blood sugar in check. However, for some, metformin alone isn't quite enough to get their blood sugar to a healthy level.
In this study, researchers want to see if orforglipron can be a good option for these individuals. They're comparing it directly with another medication that is already approved and used for type 2 diabetes, called dapagliflozin. By comparing these two drugs, the study aims to understand how effective orforglipron is at lowering blood sugar and whether it has any side effects compared to a known treatment.
This is a "Phase 3" study, which is an important stage in developing new medicines. It means the drug has already been tested in smaller groups and is now being looked at in a larger group of people to confirm its benefits and safety. The main focus is to measure changes in a blood test called HbA1c, which gives an average picture of blood sugar levels over the past few months. Ultimately, this research could lead to new and better ways to treat type 2 diabetes, offering more choices for patients and their doctors.
Key takeaways
- This study evaluates a new type 2 diabetes drug, orforglipron.
- It compares orforglipron with an existing drug, dapagliflozin.
- Participants must have type 2 diabetes and be taking metformin.
- The main goal is to see how well drugs lower average blood sugar (HbA1c).
- It's a Phase 3 study, meaning it's a critical step before potential approval.
- Participation involves taking daily medication and regular clinic visits.
Who may be eligible?
To join this study, you need to be an adult, aged at least 18 years old. The study is open to both men and women.
You must have been diagnosed with type 2 diabetes, and your doctor should agree that your blood sugar isn't as well controlled as it could be, even though you're already taking metformin.
There might be other health requirements or conditions that mean you can't take part, to make sure the study is safe for everyone involved and that the results are clear. These will be discussed in detail by the study team if you express interest.
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 metformin for your diabetes?
- Is your diabetes still not as well-controlled as your doctor would like, even with metformin?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either the new drug, orforglipron, or the existing drug, dapagliflozin. This means neither you nor your doctor will choose which medicine you get. You'll take the study medication once a day by mouth. Over the course of the study, you'll have several visits to the clinic for medical check-ups, blood tests, and to make sure you're doing well. The study involves regular monitoring to assess your blood sugar levels and overall health. You will also have follow-up appointments after you stop taking the study medication. The total duration of your involvement, including all visits and follow-up, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is type 2 diabetes?
Type 2 diabetes is a common condition where your body doesn't use insulin properly or can't make enough of it, leading to high blood sugar levels. It can cause serious health problems if not managed.
What is HbA1c?
HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months. It's a key measure of how well your diabetes is being controlled.
Why are new treatments for diabetes needed?
Even with existing medications, some people still struggle to control their blood sugar. New treatments could offer more effective options, fewer side effects, or a different way to manage the condition.
Will I know which drug I'm taking?
Because this is an 'open-label' study, you and your doctor will know which medication you are receiving (either orforglipron or dapagliflozin).
What does 'Phase 3' mean for a study?
Phase 3 means this is a large-scale study testing a new drug. It's designed to confirm how well the drug works and its safety in a bigger group of people, before it could potentially be approved for general use.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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