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G-Pump

Phase 2

Hypoglycemia | Small molecule | Metabolic |Xeris Biopharma Holdings, Inc.|Last Updated: Oct 30, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

G-Pump · 1 trial · 2 indications

Phase 2 1
NCT02733588Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery PatientsHypoglycemia
COMPLETED8 Analytics
PHASE2COMPLETED
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
HypoglycemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Detection/Notification of Hypoglycemia
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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
G-Pump™ (glucagon infusion)EXPERIMENTAL0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump

Interventions

NameTypeDescription
G-Pump™ (glucagon infusion)DRUG0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 inform...

Countries:United States
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Frequently asked questions about G-Pump

What is G-Pump used for?

G-Pump is an investigational small molecule being developed for hypoglycemia, specifically to prevent hypoglycemia in post-bariatric surgery patients. It is delivered as a glucagon infusion from an OmniPod device. G-Pump is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does G-Pump target?

G-Pump is a glucagon infusion, meaning it delivers glucagon to raise blood glucose levels. Glucagon is a hormone that counteracts insulin and helps prevent or treat hypoglycemia. By providing a continuous infusion, G-Pump aims to maintain glucose levels and prevent episodes of low blood sugar in patients who have undergone bariatric surgery.

Who makes G-Pump?

G-Pump is being developed by Xeris Biopharma Holdings, Inc., a company traded on the stock exchange under the ticker symbol XERS. Xeris Biopharma is responsible for the clinical development of G-Pump for the prevention of hypoglycemia in post-bariatric surgery patients.

What phase is G-Pump in?

G-Pump is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials. The Phase 2 trial for G-Pump has been completed, and the drug is not yet available for commercial use.

What clinical trials is G-Pump in?

G-Pump has one completed Phase 2 clinical trial with the identifier NCT02733588. The trial was titled 'Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients' and enrolled 8 participants in the United States. The study was uncontrolled and not blinded, and it included adults aged 18 years and older.

Is G-Pump the same as glucagon?

G-Pump is a glucagon infusion product, meaning it delivers the hormone glucagon to the body. It is not a different drug but a specific formulation and delivery method for glucagon. G-Pump is designed to be administered via an OmniPod device to provide a continuous infusion of glucagon to prevent hypoglycemia.