A phase 3, randomised, double-blind, placebo-controlled study assessing the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin.
This study is testing a medicine called gliclazide MR to see how well it works and if it's safe for people with type 2 diabetes. Participants will be those whose blood sugar levels aren’t well controlled, even though they are already taking dapagliflozin (which might also be known as Forxiga) or metformin, or both. Researchers want to find out if adding gliclazide MR helps to lower blood sugar (measured by something called HbA1c) over 24 weeks, which is about six months. They will also be checking for any side effects, like low blood sugar or infections, and monitoring general health to make sure the treatment is safe.
At a glance
What is this study about?
This research is a 'Phase 3' study, which means it's a very important step in checking if a new treatment is safe and effective before it can be widely used. For this study, doctors are looking at a specific medicine called gliclazide MR. It's often used for people with type 2 diabetes.
The main goal is to see if adding gliclazide MR helps to improve blood sugar control for people who already take dapagliflozin (known by its brand name Forxiga) and/or metformin, but whose diabetes isn't as well managed as their doctors would like. This study is 'double-blind' and 'placebo-controlled.' This means neither the patients nor their doctors will know if they are getting the actual gliclazide MR or a dummy pill (placebo). This is a standard way to make sure the results are fair and accurate.
Over about six months (24 weeks), the study will closely monitor participants' blood sugar levels using a measurement called HbA1c. This gives an average picture of blood sugar over the past few months. They will also look at how many people reach target blood sugar levels without experiencing really low blood sugar. Importantly, they will carefully track any side effects, including common ones like low blood sugar (hypoglycaemia), urinary tract infections (UTIs), or genital infections, to understand the safety of the treatment.
Key takeaways
- This study is for adults with type 2 diabetes.
- It aims to see if gliclazide MR helps control blood sugar better.
- Participants must already be taking dapagliflozin (and possibly metformin).
- It involves regular clinic visits and health checks over 24 weeks.
- Some people will get the active medicine, others a dummy pill (placebo).
- Patient safety and side effects are carefully monitored.
Who may be eligible?
To be able to take part in this study, you must be an adult, 18 years old or older. The study is open to both men and women.
A key requirement is that you have been diagnosed with type 2 diabetes. Importantly, your diabetes should not be well controlled, even though you are already taking a medicine called dapagliflozin (brand name Forxiga). You might also be taking metformin alongside dapagliflozin, or just dapagliflozin on its own.
There will also be other health checks and requirements that the study team will discuss with you. These are in place to make sure the study is safe for you and that the results are clear.
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 dapagliflozin (Forxiga) for your diabetes?
- Are your blood sugar levels still not as well controlled as your doctor would like?
- Are you willing to attend regular clinic appointments for about six months?
What does participation involve?
If you decide to take part, you would receive either the gliclazide MR medicine or a placebo (a dummy pill that looks the same but contains no active medicine). You'd continue to take your current dapagliflozin (and metformin, if applicable). You wouldn't know which one you're getting, and neither would your doctor.
Over about 24 weeks (roughly six months), you would have several visits to the clinic. During these visits, the study team would check your blood sugar levels (including HbA1c and fasting blood sugar), measure your weight, blood pressure, and heart rate. You would also have blood tests and regularly be asked about your health and any side effects you might be experiencing, particularly low blood sugar, infections, or other changes.
Throughout the study, you'd be given the study medicine to take regularly. It's important to follow the instructions carefully. There would also be a final check-up at the end to see how you responded and if there were any lasting effects. The full duration of your active involvement would be around 24 weeks.
Potential risks and benefits
Locations (5)
- —UnverifiedBulgaria
- —UnverifiedLithuania
- —UnverifiedLatvia
- —UnverifiedHungary
- —UnverifiedPoland
Common questions
What is gliclazide MR?
Gliclazide MR is a medicine commonly used for type 2 diabetes to help your body make more insulin and lower your blood sugar.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps compare the new medicine's effects accurately.
What is HbA1c?
HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's a key measure for managing diabetes.
Why is my diabetes 'inadequately controlled'?
This means your current diabetes medicines aren't bringing your blood sugar levels down to where your doctor would like them to be, and you might benefit from additional treatment.
Will I know if I'm getting the real medicine or the dummy pill?
No, neither you nor your doctors will know during the study. This is called 'double-blind' and helps ensure the study results are unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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