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Glucagon

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Oct 14, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment157
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01994746Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in AdultsPHASE3 COMPLETED 77 — — Nov 1, 2013Jan 1, 2015Sep 23, 20198 United States
NCT01997411Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 DiabetesPHASE2 COMPLETED 48 — — Nov 1, 2013Jan 1, 2015Aug 29, 20187 United States
NCT02806973A Study of Single or Repeated Doses of Glucagon in Participants With DiabetesPHASE1 COMPLETED 32 — — Jan 1, 2015Apr 1, 2015Oct 14, 20191 Canada
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Study Endpoints
Primary Endpoints
Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL From Glucose Nadir
Within 30 minutes after receiving glucagon at both dosing visits (glucose was measured at pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration)

Increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level defines treatment success. Due to the residual activity of circulating insulin, glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes following glucagon administration.

Maximum Change From Baseline Concentration (Cmax) of Glucagon
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
Secondary Endpoints
Nasal and Non-nasal Effects/Symptoms
Pre-dose; 15, 30, 60, and 90 post glucagon administration
Recovery From Symptoms of Hypoglycemia
Pre-dose;15, 30, 45 and 60 minutes following administration of glucagon
Time From Glucagon Administration to Blood Glucose >/=70 mg/dL or an Increase ≥20 mg/dL in Blood Glucose From Nadir
Pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nasal GlucagonEXPERIMENTALAt one visit, a glucagon dose of 3 mg was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
Intramuscular GlucagonACTIVE_COMPARATORAt a separate visit, 1 mg of glucagon was administered into the deltoid muscle of the non-dominant arm (intramuscular \[IM\]).
Nasal Glucagon (NG)EXPERIMENTALNasal glucagon (NG) doses of 2.0 mg and 3.0 mg for participants 4 to less than 12 years of age and 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.
Intramuscular (IM) GlucagonACTIVE_COMPARATORParticipants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg
Nasal Glucagon (NG) - Treatment 1EXPERIMENTALOne dose of 3 milligram (mg) NG administered in one of four study periods.
NG - Treatment 2EXPERIMENTALTwo NG doses, 3 mg each dose, administered 15 minutes apart, in the same nostril, in one of four study periods.
NG - Treatment 3EXPERIMENTALTwo NG doses, 3 mg each dose, administered 15 minutes apart, in opposite nostrils, in one of four study periods.
NG - Treatment 4EXPERIMENTALTwo NG doses, 3 mg each dose, administered one immediately after the other, in opposite nostrils, in one of four study periods.
Interventions
NameTypeDescription
Nasal GlucagonDRUG -
Intramuscular GlucagonDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: To be eligible, the following inclusion criteria must be met: * Clinical diagnosis of either type 1 diabetes receiving daily insulin since the time of diagnosis for at least 2 years or type 2 diabetes receiving multiple daily insulin doses for at least 2 years * At least 18.0 y...

Countries:United StatesCanada
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