A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes
This study is looking into a new product called AMPK Charge+®, which will be tested both on its own and alongside a common diabetes medication called semaglutide. It’s for adults who have prediabetes or type 2 diabetes. The main goal is to understand how these treatments affect blood sugar levels and other important health markers over 84 days. Participants will be organised into groups by chance and won't know which treatment they're getting. We want to find out if taking AMPK Charge+®, with or without semaglutide, helps manage blood sugar more effectively and if it's safe to use. This research could help improve future treatments for diabetes.
At a glance
What is this study about?
This study is checking out a new product called AMPK Charge+® to see how well it works and if it's safe for people with prediabetes or type 2 diabetes. Sometimes, this new product will be given on its own, and sometimes it will be given with an existing medicine called semaglutide. Doctors want to see how these treatments affect important health numbers, like blood sugar and insulin levels, over about three months.
The main thing the study wants to find out is if there's a difference in how much blood sugar levels (measured by fasting blood glucose, insulin, and a long-term average called HbA1c) change from the start of the study to day 84, depending on whether someone takes AMPK Charge+® alone or with semaglutide. This study could help us learn more about managing blood sugar for people with prediabetes or type 2 diabetes, potentially leading to better ways to help people stay healthy.
Participants will be placed into different groups by chance (this is called 'randomised'), and they won't know which treatment group they are in. This helps make sure the results are fair and accurate. They will regularly be checked to see how their bodies are responding to the treatments and if there are any side effects.
Key takeaways
- Tests a new product (AMPK Charge+®) for prediabetes or type 2 diabetes.
- Compares AMPK Charge+® alone versus with semaglutide.
- Study lasts 84 days with clinic visits.
- Aims to understand effects on blood sugar levels.
- Participants won't know which treatment they receive.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. You must have either prediabetes (where your long-term blood sugar, HbA1c, is between 6.0% and 6.5%) and not be currently taking any treatment for it, or have type 2 diabetes (HbA1c between 6.5% and 7.5%) and not be taking any treatment for it, especially if you can't take metformin.
Women who could have children must have a negative pregnancy test and agree to use reliable birth control throughout the study. This includes different methods like hormonal pills, patches, or IUDs, or your partner having had a vasectomy. If you have been through menopause for at least one year or have had certain surgical procedures (like a hysterectomy), you would also be able to join.
Before the study, your weight should have been stable, meaning you haven't gained or lost more than 5kg in the three months before starting. It's also important that you're willing to try and keep your daily habits (like diet, exercise, and any other medicines or supplements) as consistent as possible throughout the study.
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 prediabetes or type 2 diabetes and are not currently treated for it (or can't take metformin)?
- Have you maintained a stable weight recently (no more than 5kg change in 3 months)?
- Are you willing to generally keep your daily habits (like diet/exercise) consistent during the study?
- If you are a woman who could have children, are you willing to use reliable birth control during the study?
What does participation involve?
If you decide to take part in this study, you will be expected to attend several clinic visits over an 84-day period. During these visits, the study team will carry out health checks, such as measuring your blood, to see how your body is responding to the treatment. You will be given either the new product, AMPK Charge+® (sometimes with semaglutide), or a different version for your group, but you won't know which one this is.
You'll be asked to keep track of certain things, like filling out questionnaires or diaries. These help the doctors understand your experience and how you're feeling throughout the study. It's important to try and keep your usual daily routines, like what you eat and how much you exercise, as consistent as possible during the study. The total duration of your active participation in the study will be 84 days, with follow-up appointments during that time.
Potential risks and benefits
Locations (1)
- KGK Science Inc.Verified postcodeLondon, Canada· Recruiting
Common questions
What is prediabetes and Type 2 Diabetes?
Prediabetes means your blood sugar levels are higher than normal, but not high enough to be called Type 2 Diabetes. Type 2 Diabetes means your body doesn't use insulin properly, causing blood sugar levels to be too high.
What is Semaglutide?
Semaglutide is a medicine often used to help manage blood sugar levels in people with Type 2 Diabetes, and sometimes for weight management.
How long will I be in the study?
The study will last for 84 days, which is about three months, during which you'll have regular check-ups.
Will I know which treatment I am getting?
No, this is a 'single-blind' study, meaning you won't know if you're receiving AMPK Charge+® alone or with semaglutide. This helps keep the results fair.
Can I continue my usual diabetes medication during the study?
This study is for people who are not currently taking medication for their prediabetes or type 2 diabetes, or for whom metformin isn't suitable. You should discuss your current medications with the study team.
How to find out more
Marc Moulin, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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