This new study (RLM 3071-305-020) will follow participants for up to five years to provide additional information on the long-term safety profile of relamorelin.1 It also enables eligible patients to potentially have access to relamorelin until it is commercially available. The clinical goal of this study is to collect additional information on the long-term safety of relamorelin in this highly challenging patient population.1
Diabetes is the leading cause of gastroparesis and affects millions of diabetic patients.2 It is a disorder in which there is a substantial delay in stomach emptying and is characterized by nausea, vomiting, bloating, and other gastrointestinal complications.3 This delay can worsen a patient's diabetes by making it more difficult to manage blood sugar,3 which is of paramount importance to patients with diabetes.4
"The goal of managing diabetes is to keep blood sugar levels within a safe range. This is problematic in people with diabetic gastroparesis, or DG, because they cannot predict when the food or medicine will be absorbed and what impact this delay will have on their blood sugar levels," said Dr.
PLEDGE is a multi-study, patient-centric program designed to evaluate the safety and efficacy of relamorelin in people with DG.
"The PLEDGE program is one of
For more information on the PLEDGE program, or to participate, visit www.AllerganDG.com.
More About Relamorelin
Relamorelin is a potent ghrelin agonist in development for the treatment of diabetic gastroparesis.6 Relamorelin is administered via subcutaneous injection.7
More About the PLEDGE Clinical Research Program
PLEDGE consists of five studies with up to a five-year commitment.:
More About Diabetic Gastroparesis
Diabetic gastroparesis is a disorder in patients with diabetes in which there is a substantial delay in stomach emptying with characteristic signs and symptoms of vomiting, nausea, abdominal pain, early satiety, postprandial fullness, and bloating.3 Moderate to severe diabetic gastroparesis results in significant debility and hospitalizations and can interfere with nutrition and the absorption of medications.11 Up to 50 percent of patients with type 1 and type 2 diabetes have been found to have delayed gastric emptying.12 However, diagnosed prevalence of symptomatic diabetic gastroparesis has been estimated to be as low as five percent of patients with type 1 diabetes and one percent of patients with type 2 diabetes, possibly reflecting under-recognition in clinical practice.2 There is high unmet need in this patient population as available therapies to treat this disorder are limited and may exhibit significant side effects.13
About
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1 |
Allergan. (2018). Diabetic Gastroparesis Study 05. (ClinicalTrials.gov Identifier: NCT03786380). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03786380 |
2 |
Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Melton LJ 3rd, Talley NJ. Risk of gastroparesis in subjects with type 1 and 2 diabetes in the general population. Am J Gastroenterol. 2011;107(1):82–88. doi:10.1038/ajg.2011.310 |
3 |
Gastroparesis. (2017, October 16). Retrieved from http://www.diabetes.org/living-with-diabetes/complications/gastroparesis.html |
4 |
Tight Diabetes Control. (2018, January 7). Retrieved from http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/tight-diabetes-control.html |
5 |
Camilleri, M., McCallum, R. W., Tack, J., Spence, S. C., Gottesdiener, K., & Fiedorek, F. T. (2017). Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study. Gastroenterology, 153(5), 1240-1250.e2. |
6 |
Camilleri, M., & Acosta, A. (2014). Emerging treatments in Neurogastroenterology: relamorelin: a novel gastrocolokinetic synthetic ghrelin agonist. Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society, 27(3), 324-32. |
7 |
Allergan. (2018). A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis. (ClinicalTrials.gov Identifier: NCT03285308). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03285308 |
8 |
Allergan. (2018). Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02. (ClinicalTrials.gov Identifier: NCT03426345). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03426345 |
9 |
Allergan. (2018). A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03. (ClinicalTrials.gov Identifier: NCT03420781). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03420781 |
10 |
Allergan. (2017). A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04. (ClinicalTrials.gov Identifier: NCT03383146). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03383146 |
11 |
Krishnasamy, S., & Abell, T. L. (2018). Diabetic Gastroparesis: Principles and Current Trends in Management. Diabetes therapy : research, treatment and education of diabetes and related disorders, 9(Suppl 1), 1-42. |
12 |
Gastroparesis. (2012). Retrieved from https://rarediseases.org/rare-diseases/gastroparesis/ |
13 |
Parkman HP, Fass R, Foxx-Orenstein AE. Treatment of patients with diabetic gastroparesis. Gastroenterol Hepatol (N Y). 2010;6(6):1-16. |
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