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NNC 55-0414

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Feb 24, 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00400283A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 DiabetesPHASE1 COMPLETED 23Jan 19, 2001May 3, 2001Feb 24, 20171 Germany
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Study Endpoints
Primary Endpoints
To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
NNC 55-0414DRUG -
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Eligibility Criteria
Age Range40 Years — 74 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 2 diabetes * Diet treatment only for at least two weeks * Body mass index (BMI) between 22-34 kg/m2 inclusive * HbA1C between 6.5-12.0% inclusive * Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive * Patients should be negative (lesser than 70 kU/l) for antibo...

Countries:Germany
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