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NNC0143-0406

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Feb 26, 2018

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02938572A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes MellitusPHASE1 COMPLETED 47Oct 19, 2016Jul 4, 2017Feb 26, 20181 Austria
NCT02612844A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 DiabetesPHASE1 COMPLETED 48Nov 1, 2015Jun 1, 2016Dec 6, 20171 Austria
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Study Endpoints
Primary Endpoints
The ratio of suppression of endogenous glucose production relative to total glucose lowering effect
Two weeks of treatment
The number of treatment emergent adverse events
From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days.
Secondary Endpoints
Number of treatment emergent adverse events
Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration
Area under the serum NNC0143-0406 concentration-time curve
From 0 to 24 hours
Area under the glucose infusion rate-time curve
From 0 to 24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0143-0406EXPERIMENTAL -
Insulin aspartACTIVE_COMPARATOR -
Interventions
NameTypeDescription
NNC0143-0406DRUGAdministered subcutaneously (s.c. under the skin)
Insulin AspartDRUGAdministered subcutaneously (s.c. under the skin)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female aged 18-55 years (both inclusive) at the time of signing informed consent * Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening * Treated with continuous subcutaneous insulin infusion at least 90 days pri...

Countries:Austria
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