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

Completed · Phase 2

Conditions studied: Hypoglycemia, Complications of Bariatric Procedures

In brief

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.

Key facts

Study ID

NCT02733588

Run by

Xeris Pharmaceuticals

People needed

8

Starts

2016-03-01

Expected to finish

2017-06-01

Last updated by the study team

2018-10-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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