Do you have diabetic gastroparesis?

If so, consider joining envision 3D study, a diabetic gastroparesis clinical trial investigating a potential delayed gastric emptying treatment.

 

What is the envision 3D study?

envision 3D is researching CIN-102, a study medication called CIN-102 (deudomperidone). The envision 3D study is for people who have gastroparesis and diabetes type 1 or 2.

 

Who can join the envision 3D study?

You may be able to join the study if you meet the following requirements:

• Age 18 or older
• Diagnosed with Type 1 or Type 2 diabetes
• Diagnosed with gastroparesis, including gastrointestinal symptoms such as:
  • Nausea or vomiting after eating
  • feeling too full after eating
  • bloating
  • throat or stomach pain within the last 6 months
  • documented delayed gastric emptying within the last 2 years.

 

What will happen during the study?

For participants: This tool is to help you understand what to expect during the envision 3D study.

1. Read and sign the Informed Consent Form (ICF) before you receive any study assessments.
2. Confirm study requirements – Visit the study clinic 2 times over < 5 weeks for study assessments to confirm if you qualify for the study. This is called Screening.
3. Be assigned to a study group – Be assigned at random to receive either the study medication (CIN-102) or a placebo (no active ingredients).
4. Take study capsules for 12 weeks – Take 2 capsules of the study medication or placebo twice per day for 12 weeks.
5. Attend study clinic visits – Visit the study clinic 4 times over 12 weeks for study health assessments.
6. Complete study follow-up – Visit the study clinic 1 more time for final health assessments, 1 week after your last dose.

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.

 

About the Study Medication

You may qualify for a diabetic gastroparesis clinical trial researching a new potential medication.

What is the study medication?

The study medication, called CIN-102 or deudomperidone, is a new form of domperidone. Domperidone is used in many countries outside of the United States for symptoms of diabetic gastroparesis. Unfortunately, domperidone can have serious side effects, so it is not approved for use in the United States but can be used under a special agreement between a physician and the Food and Drug Administration.

Deudomperidone is made by slightly changing domperidone. It is expected to have similar benefits with fewer side effects. However, more research is needed.

Will I receive the study medication?

Participants will be assigned at random (like the flip of a coin) to receive either the study medication (CIN-102) or placebo (no active ingredients)

What is an “investigational medicine?”

Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the envision 3D study.

 

About Diabetic Gastroparesis

You may qualify for the envision 3D study investigating deudomperidone for diabetic gastroparesis. Learn more about diabetes and delayed gastric emptying.

What is diabetic gastroparesis?

Diabetic gastroparesis is a condition that causes the stomach to not empty normally. It occurs in people with type 1 or 2 diabetes who experience damage to the vagus nerve. The vagus nerve helps your stomach muscles move food through the stomach and into the digestive tract. Once the vagus nerve is damaged, it can cause stomach discomfort, severe nausea, or vomiting after eating. These symptoms can be hard to manage and lead to other complications.

Although a medication (domperidone) to treat diabetic gastroparesis is used in many countries, it is not approved in the United States because it has been associated with serious side effects. It can be used under a special agreement between a physician and the Food and Drug Administration. The study medication (deudomperidone) is expected to have similar benefits with fewer side effects. What we learn from the envision 3D study may help researchers learn more about a potential new option for people with diabetic gastroparesis.

Other common terms for gastroparesis are:

• Delayed gastric emptying
• Slow stomach emptying
• Lazy stomach
• Gastropathy

Where can I learn more?

https://www.mayoclinic.org/gastroparesis-causes

The FLAIR Study – Now Enrolling

The FLAIR Study is evaluating the effectiveness and safety of a combination of 2 commercially approved drugs, fluticasone (Fp) and albuterol (ABS), in a single inhaler compared to albuterol (ABS) alone for asthma attacks in adults, adolescents, and children with asthma.

The study will determine if using the study combination will reduce the occurrence of asthma episodes (“attacks”) that require systemic corticosteroids or hospitalizations for treatment.

Important Study Information

• During the study, participants will continue taking their usual asthma maintenance medication
• Participants will be in the study for at least 6 months
• The investigational study drug and study procedures are provided at no charge
• Travel and study-related costs may be reimbursed
• There is no placebo arm in this study; participants will receive either the study drug combination or ABS
• The study enrollment is expected to last until approximately the third quarter of 2025

Who can participate in the FLAIR Study?

To participate in this study, you must:

• Be 18 years of age or older
• Be diagnosed with asthma for at least 1 year
• Have had 1 or more severe asthma attacks in the past 12 months

There are also other requirements that will determine who can participate. A doctor will determine if you are medically eligible to take part in this study.