A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Mellitus (MK-8835-059/B1521066)
This important study is testing a new medicine called ertugliflozin for young people with type 2 diabetes, specifically those aged 10 to 17. The main goal is to find out if this medicine can effectively lower blood sugar levels, which is measured by something called HbA1c, after 24 weeks. We'll also be carefully checking how safe the medicine is by looking at any side effects participants might experience over 24 and 54 weeks. Some participants will receive the new medicine, while others will get a placebo (a dummy pill) to allow us to compare the effects fairly. This is a common way to test new medicines and help us understand if they are a good option for patients.
At a glance
What is this study about?
This study is all about helping young people, aged 10 to 17, who live with type 2 diabetes. Type 2 diabetes means your body doesn't use sugar properly, leading to high blood sugar levels. Keeping blood sugar in check is really important for staying healthy and preventing problems in the future. We're testing a new medicine called ertugliflozin to see if it can help these young people manage their blood sugar.
To make sure we get reliable results, some participants will receive the new medicine, ertugliflozin, while others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps us see if any changes we observe are truly due to the medicine or if they're things that might happen anyway. Neither the participants nor the doctors will know who is getting which tablet until the study is over – this is called 'double-blind' and makes the study results more accurate.
The main thing we want to find out is whether ertugliflozin can lower a participant's average blood sugar level, measured by something called HbA1c, over 24 weeks. We'll also be very carefully watching for any side effects and how participants feel throughout the study, which will last for 54 weeks. The information we gather will help doctors understand if ertugliflozin could be a valuable new treatment option for young people with type 2 diabetes.
Key takeaways
- This study is for young people (10-17 years) with type 2 diabetes.
- It's testing a new medicine called ertugliflozin against a dummy pill (placebo).
- The main aim is to see if ertugliflozin helps lower blood sugar (HbA1c) and if it's safe.
- Participation involves regular clinic visits and careful health checks over 54 weeks.
- You won't know if you're getting the medicine or placebo until the study ends.
Who may be eligible?
This study is designed for young people aged 10 to 17, as long as they have been diagnosed with type 2 diabetes. Both boys and girls can take part.
Beyond having type 2 diabetes and being within the age range, there will be other specific health checks and medical requirements. These are put in place to make sure that the study is safe for everyone taking part and that the results we get are clear and useful.
The research team will carry out these checks to confirm if someone is suitable. They will discuss all the requirements with you and your parent or guardian to make sure you have all the information you need.
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 between 10 and 17 years old?
- Have you been diagnosed with type 2 diabetes?
- Are you (and your parent/guardian, if applicable) able to attend regular clinic appointments?
- Are you willing to take a study medicine or placebo as instructed?
What does participation involve?
If you decide to take part in this study, you'll be given either the new medicine, ertugliflozin, or a placebo (a dummy pill, which looks the same but has no medicine in it). You'll take these as film-coated tablets. You won't know if you're getting the active medicine or the placebo, and neither will your study doctor – this helps make the study fair.
You'll need to visit the study clinic regularly. At these visits, doctors and nurses will check your health, measure your blood sugar, and ask how you're feeling. They'll also monitor for any side effects. These visits will happen over 54 weeks (about a year).
During the study, you'll be carefully supported by the study team, who will explain everything and make sure you understand each step. The main goal is to see how the medicine affects your blood sugar over 24 weeks and to keep an eye on your overall health and safety for the full 54 weeks.
Potential risks and benefits
Locations (3)
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedHungary
Common questions
What is ertugliflozin?
Ertugliflozin is a new medicine being tested to see if it can help young people with type 2 diabetes control their blood sugar levels.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active ingredients. It's used for comparison.
How long does the study last?
The study involves taking the medicine and being monitored over 54 weeks, which is just over a year.
Will I know if I'm getting the medicine or the placebo?
No, neither you, your parents, nor your doctors will know until the study is finished. This helps get accurate results.
What is HbA1c?
HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's an important measure for diabetes.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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