Purpose of study
To see if Semaglutide can reduce the worsening or progression of kidney disease in people with type 2 diabetes
The FLOW study is being carried out to see if semaglutide can reduce the worsening or progression of kidney disease in people with type 2 diabetes. A previous study has shown that using semaglutide reduced the progression of kidney disease and the risk of cardiovascular events in some people with type 2 diabetes. Semaglutide is already approved in some countries to treat type 2 diabetes.
What are the benefits of taking part in FLOW?
There are several potential benefits in taking part in FLOW, for example:
- Take a more active role in your own healthcare
- Get regular expert medical care at healthcare facilities
- Have additional tasks with the study staff to discuss healthy lifestyle choices
- Receive the trial medication for free
- Help others by contributing to medical research
What are the potential drawbacks?
There may be some potential drawbacks to taking part in FLOW:
- You may experience side effects. The most common side effects of semaglutide are nausea, diarrhea, and vomiting
- Your study medicine may prove to be ineffective against kidney problems
- The study may require more of your time and attention than normal treatment, and may include extra clinic visits or more complex treatment requirements
You may be reimbursed for travel expenses associated with taking part in this study. As well, you may be supplied with ancillary products while in the study such as a glucometer and testing strips.
Scope of Project
What will be required if I take part?
Initially, you will go through a screening process to ensure that you meet the criteria or rules for being included in the FLOW study. If you do, your doctor will explain exactly what is expected of a study participant so you can make an informed decision. Participation in the FLOW study will include:
- A once-weekly injection of the study medicine, prescribed by the study doctor
- Attending regular study visits for study related health checks
- Regular contact with the study nurse or doctor throughout the study
Will I know if I have placebo or the real medicine?
FLOW is a ‘placebo-controlled’ study, which means half of the people in the study will be given a ‘dummy’ medicine called a placebo.
- You will be randomly assigned to either the study medicine (semaglutide) or the placebo for the full length of the study.
- You will not know which medicine you have and neither will your study doctor or the study team. At the end of the study, you will be told which medicine you were given. You will also have an opportunity to see the results of the study.
How do my personal study results contribute to the final study results?
The information collected from you during the study is made anonymous, and entered into a database together with information from everyone else in the study. This is then analysed by doctors and scientists. In order for the results to be meaningful, it is very important that everybody in the study continues until the end.
Do I need to attend every study visit?
The FLOW study will last for approximately 5 years in order to get a clear picture of the effect of the study medicine over time. Attending regular study visits help us to understand the effect of the medicine, as well as giving you the opportunity to discuss any health related questions or concerns with your study doctor.
You will be able to discuss the visits with your study doctor and organise times that work best with your schedule. You may also be able to phone the site for some visits, rather than attending in person
Should I still go to my clinic visits if I stop taking the study medicine?
Even if you or your study doctor make the decision to stop taking the study medicine ahead of schedule, it is still very important for you to attend as many visits as possible until the end of the study! Valuable information can still be collected, and the study doctors can monitor your progress and health. Every patient’s information is important for the overall success of the study.
Will being in the FLOW study affect my other medicines?
You will continue to take any other prescribed medicines throughout the study as required.
What should I do if I become pregnant during the study?
You should not take part in this study if you are pregnant, breastfeeding, or planning to get pregnant. If you become pregnant during the study, you should stop taking your study medicine immediately and tell the study staff.
Will I get paid?
You will not receive any compensation for time spent at the clinic or for taking part in the study. You may be reimbursed for travel expenses. Please speak to the study staff about reimbursement.
How will my participation in FLOW benefit others?
Choosing to take part in a clinical study is an important decision. By attending your study visits, you will help us to understand how safe the study medicine is, and how well it works. The results from this study will inform treatment for other people with kidney disease and type 2 diabetes
This study is run by Dr. Christopher Kovacs via Laura Genge, Research Coordinator. The number to the patient research center is: 709-777-6996.
If you have any questions, about your rights as a research participant, please contact HREA Ethics Office at 709-777-6974 or email: email@example.com
This study is being sponsored by Novo Nordisk, a global healthcare company with more than 95 years of innovation and leadership in diabetes care.