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

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ClinicalTrials.gov Identifier: NCT02733588
Recruitment Status : Completed
First Posted : April 11, 2016
Results First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Xeris Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Complications of Bariatric Procedures Drug: G-Pump™ (glucagon infusion) Phase 2

Detailed Description:

This is a Phase 2a, single-center, open-label, proof-of-concept study designed to test the ability of the control algorithm to detect and direct timing of G-Pump™ glucagon infused from an OmniPod® pump to prevent hypoglycemia in patients with post-bariatric hypoglycemia syndrome. While the algorithm will provide an alert as to when glucagon should be dosed to prevent hypoglycemia, there will be no automation in this clinical trial and it will ultimately be up to the physician to initiate dosing via the OmniPod® controller.

Participant on continuous glucose monitoring will arrive at the clinic and IV line will be inserted for venous access. Subject will then be asked to drink a liquid mixed meal containing 60 g of carbohydrates, e.g. Boost® Nutritional Drink, over 10 minutes. Blood samples will be collected for glucose and hormone measurement.

The open-loop system will be set to recognize low sensor glucose values, triggering an alert to the physician, who will deliver a bolus of 150 or 300 µg of glucagon via the pump, with the goal of preventing further decline in glucose values. Depending on response, a second bolus dose of 150 or 300 µg of glucagon may be administered. Plasma glucose will be measured after glucagon administration to ensure successful treatment and glucose stability, and glucagon levels will be analyzed concurrently to determine magnitude of increase above baseline. Sensors will be downloaded for subsequent analysis of appropriateness of alert timing and trigger for glucagon bolus delivery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-Concept Study of Sensor-Guided, Clinician-Administered Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Post-Prandial Hypoglycemia in Post-Bariatric Surgery Patients
Study Start Date : March 2016
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: G-Pump™ (glucagon infusion)
0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Drug: G-Pump™ (glucagon infusion)
0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Other Name: glucagon




Primary Outcome Measures :
  1. Detection/Notification of Hypoglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    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.


Secondary Outcome Measures :
  1. Number of Subjects With Severe Hypoglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.

  2. Number of Subjects With Rebound Hyperglycemia [ Time Frame: 0 - 120 minutes following dosing ]
    Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.

  3. Glucose Time in Range [ Time Frame: 0 - 120 minutes following dosing ]
    Time glucose remains in goal range, 60-180 mg/dl, reported in minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733588


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Xeris Pharmaceuticals
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by Xeris Pharmaceuticals:
Study Protocol  [PDF] February 13, 2017
Statistical Analysis Plan  [PDF] February 13, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02733588    
Other Study ID Numbers: XSGO-PB01
1R44DK107114-01 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2016    Key Record Dates
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xeris Pharmaceuticals:
hypoglycemia
glucagon
glucose metabolism disorders
hormones
gastrointestinal agents
bariatric surgery
incretins
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins