A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis - Diabetic Gastroparesis Study 1

ALLERGAN LIMITED0 sites2,500 target enrollmentFebruary 4, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 4, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male and female participants aged 18 years or older at screening (Visit 1\)
•2\. T1DM or T2DM of at least 5 years' duration, with controlled and stable blood glucose levels (ie, no episodes of diabetic
•ketoacidosis, Hyperosmolar Hyperglycemic Nonketotic Diabetic Syndrome, or severe hypoglycemia within the 6 months preceding screening \[Visit 1])
•3\. HbA1c .11\.0% at screening (Visit 1\) in participants being treated with oral and/or parenteral medications for T1DM or T2DM
•with the goal of achieving controlled and stable glucose levels
•4\. DG defined as at least a 3\-month history prior to screening (Visit 1\) of symptoms on an ongoing basis that are suggestive of GP
•(eg, nausea, abdominal pain, post\-prandial fullness, bloating, vomiting, and early satiety)
•5\. Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow\-up period
•A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization),
•not breastfeeding, and at least one of the following conditions applies:

•1\. Symptomatic Irritable Bowel Syndrome at Screening (Visit 1\)
•2\. Small intestinal bacterial overgrowth (SIBO) at Screening (Visit 1\)
•3\. History of anorexia nervosa, binge\-eating, bulimia, or other eating disorder within 5 years of screening (Visit 1\)
•4\. History of intestinal malabsorption (including celiac disease even if well\-controlled on a gluten\-free diet) or pancreatic exocrine
•insufficiency; also, history of non\-celiac gluten sensitivity
•5\. History of belching disorders, other nausea and vomiting disorders (eg, chronic nausea and vomiting syndrome, cyclic vomiting
•syndrome, cannabinoid hyperemesis syndrome), or rumination syndrome
•6\. History of chronic obstructive pulmonary disease or other causes of pulmonary dysfunction that have resulted in CO2 retention
•7\. Gastric or duodenal ulcer within 3 months of Screening (Visit 1\)
•8\. Evidence of hepatic disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 x ULN, and/or