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NovoPen 4, NovoPen 3

Phase 3

Diabetes | Unknown | Metabolic |Novo Nordisk A/S|Last Updated: Jan 19, 2017

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment208
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00569998Comparison of Two Pen Systems in Patients With Diabetes Treated With InsulinPHASE3 COMPLETED 208Aug 1, 2003Feb 1, 2004Jan 19, 201723 Austria, Germany +3
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Study Endpoints
Primary Endpoints
Evaluation of overall pen preference
after 12 weeks of treatment
Secondary Endpoints
HbA1c
Adverse device effects
Adverse events
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
NovoPen™ 4DEVICE -
NovoPen® 3DEVICE -
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Eligibility Criteria
Age Range9 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Type 1 or type 2 diabetes mellitus for at least 12 months * Adults at least 18 years * Children/adolescents between 9-18 years * HbA1c lesser than or equal to 11.0% Exclusion Criteria: * Known or suspected alcohol or drug abuse * Patients who are not able to read the user ma...

Countries:AustriaGermanyItalyNetherlandsUnited Kingdom
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