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Novo Nordisk GlucaGen

Phase 2

Hypoglycemia | Small molecule | Metabolic |Xeris Biopharma Holdings, Inc.|Last Updated: Apr 6, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Novo Nordisk GlucaGen · 1 trial · 1 indication

Phase 2 1
NCT02081001PK/PD Study With G-Pump (Glucagon Infusion) in T1DM PatientsHypoglycemia
COMPLETED19 Analytics
PHASE2COMPLETED
PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
HypoglycemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
0 to 150 minutes post-dosing

The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.

Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
0 to 150 minutes post-dosing

The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.

Secondary Endpoints

Glucagon Cmax
From 0 to 150 minutes post-dosing
Glucose Cmax
From 0 to 150 minutes post-dosing
Glucagon Tmax
From 0 to 150 minutes post-dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
G-Pump™ (glucagon infusion)EXPERIMENTALG-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Novo Nordisk GlucaGen®ACTIVE_COMPARATORNovo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Interventions

NameTypeDescription
Novo Nordisk GlucaGen®DRUGsingle subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
G-Pump™ (glucagon infusion)DRUGsingle subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males or females diagnosed with type 1 diabetes mellitus for at least 24 months * Current usage of subcutaneous insulin pump treatment * Age 18-65 years * C-peptide level \< 0.5 ng/ml * Willingness to follow all study procedures, including attending all clinic visits * Subject...

Countries:United States
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Frequently asked questions about Novo Nordisk GlucaGen

What is Novo Nordisk GlucaGen used for?

Novo Nordisk GlucaGen is used for hypoglycemia, a condition of abnormally low blood sugar. It is being developed as a treatment for this metabolic condition. The drug is currently in clinical development for this indication.

Who makes Novo Nordisk GlucaGen?

Novo Nordisk GlucaGen is being developed by Xeris Biopharma Holdings, Inc., a company traded on the stock exchange under the ticker XERS. The drug is currently in Phase 2 clinical development for the treatment of hypoglycemia.

What phase is Novo Nordisk GlucaGen in?

Novo Nordisk GlucaGen is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed.

What clinical trials is Novo Nordisk GlucaGen in?

Novo Nordisk GlucaGen has one completed clinical trial, identified as NCT02081001. This was a Phase 2 study titled 'PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients,' which enrolled 19 participants with hypoglycemia in the United States.

Is Novo Nordisk GlucaGen the same as G-Pump?

Novo Nordisk GlucaGen is associated with the G-Pump in the context of a clinical trial. The study NCT02081001 evaluated the drug using a G-Pump glucagon infusion device in patients with type 1 diabetes and hypoglycemia.