This phase 3 clinical trial is investigating the effects of relamorelin on diabetic gastroparesis. The main outcomes to be measured will be the percentage of patients that experience a reduction in the severity of symptoms, and the percentage that experience a reduction in vomiting.
The details
In gastroparesis the stomach takes too long to empty its contents. This leads to nausea, vomiting, abdominal pain, and a feeling of fullness after eating even a small amount of food (post-prandial fullness). Diabetes is the most common cause of gastroparesis. Diabetic gastroparesis occurs when high blood glucose levels damage nerves supplying the stomach.
Relamorelin is a drug that may improve the symptoms of diabetic gastroparesis. It may speed up stomach emptying, alter the levels of certain hormones in the blood, and increase appetite.
This trial will explore the effectivness of relamorelin in patients with diabetic gastroparesis. The main outcomes will be measured as the percentage of patients that experience a reduction in symptom severity, and the percentage that experience a reduction in vomiting.
Who are they looking for?
This trial is looking for 600 adults with type 1 or type 2 diabetes, who also have gastroparesis.
Participants may not be receiving nutrition by any kind of feeding tube. They may not have had an eating disorder in the last 5 years. They may not have celiac disease, gluten intolerance, or disorders of the stomach and intestines that may be similar to gastroparesis.
How will it work
The participants will be divided, randomly, into 2 groups. One group will receive a relamorelin injection twice a day. The other group will receive a placebo (drug with no active effect) injection twice a day. The participants will be followed up for 12 weeks.
The participants will give the severity of their diabetic gastroparesis symptoms a score of 0-10, every day, using an electronic diary. The percentage of patients whose overall symptoms are less severe, and who vomit less often, in the last 6 weeks will be noted. The percentage of patients whose nausea, abdominal pain, bloating, and post-prandial fullness symptoms become less severe in the last 6 weeks of the study will also be noted. Any side effects that occur during the study will be recorded.
