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Glucagon

Phase 1

Type 1 Diabetes Mellitus With Hypoglycemia | Small molecule | Metabolic |United Therapeutics Corporation|Last Updated: Jan 15, 2021

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04712266A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 DiabetesEARLY_PHASE1 COMPLETED 15Sep 15, 2020Jan 10, 2021Jan 15, 20211 United States
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Study Endpoints
Primary Endpoints
hypoglycemic excursions
180-360 minutes post meal

\< 50mg/dl

hyperglycemic excursions
60-120 minutes post meal

\>150mg/dl

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Insulin IVACTIVE_COMPARATORcalculated insulin rate
Insulin and Glucagon IVEXPERIMENTALcalculated molar ratio insulin:glucagon
Interventions
NameTypeDescription
GlucagonDRUGcalculated IV insulin:Glucagon molar ratio
InsulinDRUGcalculated IV Insulin dose infused at a constant rate
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patients aged between 18 and 64 years (both inclusive) * Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit * Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit Exclusion Criteria: \-

Countries:United States
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