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NNC 0148-0000-0362

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: May 29, 2015

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-BlindCONTROLLED
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01597713A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy SubjectsPHASE1 COMPLETED 83May 1, 2012Oct 1, 2012May 29, 20151 Germany
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Study Endpoints
Primary Endpoints
Number of adverse events
Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit
Secondary Endpoints
Area under the serum insulin concentration-time curve (with Trial part 1)
From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively
Area under the glucose infusion rate (GIR)-time curve (Trial part 1)
From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively
Area under the serum insulin concentration-time curve (Trial part 2)
From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1, level 1-7 escalating dosesEXPERIMENTAL -
Part 2, cross-overEXPERIMENTAL -
Interventions
NameTypeDescription
NNC 0148-0000-0362DRUGSubjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
insulin glargineDRUGAs an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
placeboDRUGSubjects will receive a single dose of oral placebo within each dose group
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index 18-28 kg/m\^2 (both inclusive) * Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by...

Countries:Germany
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