The REJUVENATE-01 study is a clinical trial that is investigating the safety and effectiveness of a potential type 2 diabetes (T2D) advanced therapy for people who have uncontrolled type 2 diabetes (T2D).
The REJUVENATE-01 study will test the investigational study drug to learn about the side effects and whether it can help control blood glucose (sugar) levels in people living with type 2 diabetes (T2D).
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You may be able to join the study if you meet the following requirements:
35-70 years old
Confirmed diagnosis of type 2 diabetes (T2D)
Type 2 diabetes (T2D) that is not well-controlled
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Currently taking at least two glucose lowering medications for type 2 diabetes (T2D)*
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Other study requirements will apply.
Participation in the REJUVENATE-01 study lasts approximately 5.5 years.
If you choose to participate, you can expect the following:
You will receive anesthesia and stay overnight at the study clinic for observation.Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Take the pre-screener to see if you may qualify!
Take the Pre-ScreenerThe investigational study drug is an investigational advanced therapy. The study medicine is designed to deliver a gene directly to cells in the pancreas. The REJUVENATE-01 study will test the investigational study drug to learn about the side effects and whether it may help control blood glucose (sugar) levels in adults with type 2 diabetes.
“Investigational” means that the study medicine is not proven to work and can only be used in research studies like the REJUVENATE-01 study.
The study doctor uses an investigational device to infuse the study medicine into the pancreas. This happens by an ultrasound-guided endoscopic procedure.
Ask the study team for more details about the procedure and the investigational device.
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All study participants will receive the investigational advanced therapy.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or Therapeutic Goods Administration (TGA) in Australia it can only be used in clinical research studies like the REJUVENATE-01 study.
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Type 2 diabetes (T2D) is a common metabolic condition that affects how the body manages glucose (sugar) in the blood. There are more than 400 million people around the globe that struggle with type 2 diabetes (T2D). Over time, high blood glucose (sugar) levels can negatively impact many parts of the body, including the eyes, kidneys, nerves, and heart. Type 2 diabetes (T2D) is influenced by a combination of genetics, lifestyle factors, and aging.
It can be difficult to manage your blood glucose (sugar) levels, multiple glucose lowering medications, a diabetic diet, and physical activity. The REJUVENATE-01 study is designed to potentially reduce blood glucose (sugar) levels for people that struggle to manage their current program or management plan for type 2 diabetes.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive. The ICF also contains information about what data is collected from you, how it is utilized, how long it is held, as well as your rights with respect to processing your data.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.