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NNC0363-0845

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 4, 2022

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 Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05134987A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It WorksPHASE1 COMPLETED 30 — — Dec 1, 2021May 6, 2022Nov 4, 20221 Austria
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Study Endpoints
Primary Endpoints
AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations
From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

messured in h\*mmol/L

Secondary Endpoints
AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations
From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations
From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations
From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0363-0845 followed by insulin detemirEXPERIMENTALParticipants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days.
Insulin detemir followed by NNC0363-0845EXPERIMENTALParticipants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days.
Interventions
NameTypeDescription
NNC0363-0845DRUGParticipants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks
Insulin detemirDRUGParticipants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key inclusion criteria: * Male participant or female participant of non-childbearing potential. Non-child-bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 m...

Countries:Austria
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