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Novo Nordisk GlucaGen

Phase 2

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

Novo Nordisk GlucaGen development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Novo Nordisk GlucaGen clinical trials

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 a glucagon-based therapy being studied for hypoglycemia, or low blood sugar. It is being evaluated in patients with type 1 diabetes who are at risk of hypoglycemia. The development program focuses on metabolic conditions.

Who is developing Novo Nordisk GlucaGen?

Novo Nordisk GlucaGen is being developed by Xeris Biopharma Holdings, Inc., which trades on the Nasdaq under the ticker XERS. Xeris is advancing the program in the metabolic therapeutic area.

What phase is Novo Nordisk GlucaGen in?

Novo Nordisk GlucaGen is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The program has completed one Phase 2 trial.

What clinical trials is Novo Nordisk GlucaGen in?

Novo Nordisk GlucaGen has been studied in one completed Phase 2 trial, NCT02081001, titled PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients. The trial enrolled 19 participants in the United States and evaluated hypoglycemia in type 1 diabetes.

Is Novo Nordisk GlucaGen the same as Novo Nordisk GlucaGen®?

Yes, Novo Nordisk GlucaGen and Novo Nordisk GlucaGen® refer to the same therapy. The registered trademark symbol is simply part of the product name.