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short-acting Insulin

Phase 3

Cystic Fibrosis | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 10, 2012

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 Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00662714Early Diagnosis of Diabetes Mellitus in Patients With Cystic FibrosisPHASE3 COMPLETED 73Sep 1, 2001Dec 1, 2011Jul 10, 201236 Austria, France +2
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Study Endpoints
Primary Endpoints
HbA1c
2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRepaglinide; oral
2ACTIVE_COMPARATORshort-acting Insulin (Actrapid)
Interventions
NameTypeDescription
RepaglinideDRUGoral; initial dose: 3x 0.5mg/d; 2 years
short-acting Insulin (Actrapid)DRUGinitial dose: 3x 0.05E/kg/d, injected; 2 years
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Eligibility Criteria
Age Range10 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: Inclusion Criteria for the Screening: * Diagnosed cystic fibrosis * Age 10 years and older Inclusion Criteria for the therapeutic part of the study: * Newly diagnosed Diabetes mellitus in the screening Exclusion Criteria: Exclusion Criteria for Screening: * Diabetic keto-a...

Countries:AustriaFranceGermanyItaly
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