This trial is examining the safety and effectiveness of relamorelin on diabetic gastroparesis (slowed digestion in diabetic patients). The main outcome to be measured will be the percentage of patients with gastroparesis symptoms.
The details
High blood glucose levels in diabetes can cause nerves to not work properly. When the nerve that supplies the stomach becomes affected, the stomach muscles stop working properly. The stomach muscles are needed to breakdown food and to move it along into the intestines. Therefore, when these muscle stop working properly food remains in the stomach for long periods of time. This is called diabetic gastroparesis (DGP). This can cause symptoms such as heart burn, nausea, vomiting, bloating and loss of appetite. Relamorelin is a new drug under development to increase stomach movement.
The purpose of this study is to test the safety and effectiveness of relamorelin on DGP. The main outcomes to be measured will be the percentage of patients with DGP symptoms after 12 weeks of treatment.
Who are they looking for?
This trial is recruiting 600 patients. Patients must meet the criteria for DGP and must comply with the diary and treatment dosing instructions.
Patients must not be receiving nutrition through any kind of feeding tube or intravenously. Patients must not have had an eating disorder in the past 5 years, have any other digestive problems or have had heartburn before they were diagnosed with diabetes.
How will it work
Patients will be randomly assigned to receive either 10 micrograms relamorelin injected under the skin twice daily or a placebo injected twice daily. Patients will be treated for 12 weeks. Patients will report on their symptoms daily into an electronic diary.
The percentage of patients meeting a specific gastroparesis symptom criterion at week 6 and 12 will be measured.
