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

NCT02733588 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: XSGO-PB011R44DK107114-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoglycemia; Complications of Bariatric Procedures

Keywords

hypoglycemia; glucagon; glucose metabolism disorders; hormones; gastrointestinal agents; bariatric surgery; incretins

Outcome Measures

Primary Outcomes (1)

• Detection/Notification of Hypoglycemia

  Frequency with which the device controller software correctly identifies impending hypoglycemia (glucose \< 75 mg/dl) and notifies the investigator to initiate treatment. Reported as the number of successful identifications.

  0 - 120 minutes following dosing

Secondary Outcomes (3)

• Number of Subjects With Severe Hypoglycemia

  0 - 120 minutes following dosing

• Number of Subjects With Rebound Hyperglycemia

  0 - 120 minutes following dosing

• Glucose Time in Range

  0 - 120 minutes following dosing

Study Arms (1)

G-Pump™ (glucagon infusion)

EXPERIMENTAL

0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump

Drug: G-Pump™ (glucagon infusion)

Interventions

G-Pump™ (glucagon infusion) DRUG

0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump

Also known as: glucagon

G-Pump™ (glucagon infusion)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Xeris Pharmaceuticals: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Laguna Sanz AJ, Mulla CM, Fowler KM, Cloutier E, Goldfine AB, Newswanger B, Cummins M, Deshpande S, Prestrelski SJ, Strange P, Zisser H, Doyle FJ 3rd, Dassau E, Patti ME. Design and Clinical Evaluation of a Novel Low-Glucose Prediction Algorithm with Mini-Dose Stable Glucagon Delivery in Post-Bariatric Hypoglycemia. Diabetes Technol Ther. 2018 Feb;20(2):127-139. doi: 10.1089/dia.2017.0298.

  PMID: 29355439 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Glucose Metabolism Disorders

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Sample size was small; gender mix, although unequal, is typical of the PBH population at Joslin. The protocol was modified at every stage to test iterations of the detection algorithm and/or increasing glucagon doses to prevent hypoglycemia.

Results Point of Contact

• Title: Mary-Elizabeth Patti, MD
• Organization: Joslin Diabetes Center

mary.elizabeth.patti@joslin.harvard.edu

617-309-2665

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 11, 2016
• Study Start: March 1, 2016
• Primary Completion: April 5, 2017
• Study Completion: June 1, 2017
• Last Updated: October 30, 2018
• Results First Posted: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)