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

Primary Purpose

Hypoglycemia, Complications of Bariatric Procedures

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

G-Pump™ (glucagon infusion)

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring hypoglycemia, glucagon, glucose metabolism disorders, hormones, gastrointestinal agents, bariatric surgery, incretins

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Joslin Diabetes Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

G-Pump™ (glucagon infusion)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Subjects With Severe Hypoglycemia

Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.

Number of Subjects With Rebound Hyperglycemia

Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.

Glucose Time in Range

Time glucose remains in goal range, 60-180 mg/dl, reported in minutes

Full Information

NCT ID

NCT02733588

First Posted

March 30, 2016

Last Updated

October 28, 2018

Sponsor

Xeris Pharmaceuticals

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT02733588

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

April 5, 2017 (Actual)

Study Completion Date

June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xeris Pharmaceuticals

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia, Complications of Bariatric Procedures

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G-Pump™ (glucagon infusion)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

G-Pump™ (glucagon infusion)

Other Intervention Name(s)

glucagon

Intervention Description

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

Primary Outcome Measure Information:

Title

Detection/Notification of Hypoglycemia

Description

Time Frame

0 - 120 minutes following dosing

Secondary Outcome Measure Information:

Title

Number of Subjects With Severe Hypoglycemia

Description

Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.

Time Frame

0 - 120 minutes following dosing

Title

Number of Subjects With Rebound Hyperglycemia

Description

Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.

Time Frame

0 - 120 minutes following dosing

Title

Glucose Time in Range

Description

Time glucose remains in goal range, 60-180 mg/dl, reported in minutes

Time Frame

0 - 120 minutes following dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Joslin Diabetes Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29355439

Citation

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.

Results Reference

derived

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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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