Recent Updates
Recently added Catalysts

NovoFine needle 6 mm, NovoFine needle 4 mm

Phase 3

Diabetes | Unknown | Metabolic |Novo Nordisk A/S|Last Updated: Aug 7, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLED
Total Trials3
Total Enrollment170
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00872560Comparison of 2 NovoFine® Needles on the Reflux of InsulinPHASE3 COMPLETED 60Jan 20, 1998Jul 27, 1998Aug 7, 20181 Italy
NCT00871416Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long NeedlesPHASE3 COMPLETED 48Apr 9, 1997Jul 18, 1997Feb 28, 20171 Denmark
NCT00343343Comparison of NovoFine® Needles (4 mm vs. 6 mm)PHASE2 COMPLETED 62Jun 1, 2006Aug 1, 2006Feb 8, 20172 Denmark
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Weighing of reflux of insulin
6 seconds after injection
Location of the injected sterile, atmospheric air
after 4 injections at visit 1 and 2, respectively
Deposition of sterile air depositions.
Secondary Endpoints
Pain perception
after 6 weeks of treatment
Number and severity of bleedings
after 6 weeks of treatment
Reactions at injection sites
after 6 weeks of treatment
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
NovoFine® needle 6 mmDEVICE -
NovoFine® needle 8 mmDEVICE -
NovoFine® needle 12 mmDEVICE -
NovoFine® needle 4 mmDEVICE -
Unlock Study Design Details
Eligibility Criteria
Age Range10 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children/adolescents with type 1 diabetes mellitus * Usage of NovoPen® 1.5 for at least 3 months * Duration of insulin treatment more than 1 year * Normal weight according to Tanner scales * The means of the last 2 HbA1c measurements taken within the last 6 months must be less...

Countries:ItalyDenmark
Unlock Eligibility Criteria