Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe hypoglycemia following bariatric surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xeris Pharmaceuticals
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.

• willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion Criteria:

• documented hypoglycemia occurring in the fasting state (> 12 hours fast);

• chronic kidney disease stage 4 or 5;

• hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;

• congestive heart failure, New York Heart Association class II, III or IV;

• history of myocardial infarction, unstable angina or revascularization within the past 6 months;

• history of a cerebrovascular accident;

• seizure disorder (other than with suspect or documented hypoglycemia);

• active treatment with any diabetes medications except for acarbose;

• active malignancy, except basal cell or squamous cell skin cancers;

• personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);

• known insulinoma;

• major surgical operation within 30 days prior to screening;

• hematocrit ≤ 33%;

• bleeding disorder, treatment with warfarin, or platelet count <50,000;

• blood donation (1 pint of whole blood) within the past 2 months;

• active alcohol abuse or substance abuse;

• current administration of oral or parenteral corticosteroids;

• pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.

• use of an investigational drug within 30 days prior to screening.

• there will be no involvement of special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.