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NN1952

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 25, 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-BlindCONTROLLED
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01028404A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 DiabetesPHASE1 COMPLETED 84Nov 1, 2009Jun 1, 2010Jul 25, 20171 Germany
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Study Endpoints
Primary Endpoints
Number and severity of adverse events for trial part 1
from visit 1 to visit 3
Number and severity of adverse events for trial part 2
from visit 1 to visit 6
Secondary Endpoints
Area under the serum insulin concentration-time curve after a single dose
after 12 hours
Area under the glucose infusion rate-time curve after a single dose
after 12 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Trial part 1EXPERIMENTAL -
Trial part 2EXPERIMENTAL -
Interventions
NameTypeDescription
NN1952DRUGSubjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
insulin aspartDRUGAs an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
placeboDRUGSubjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * FOR TRIAL PART 1, THE FOLLOWING APPLIES: * Gender: male * Age: 18-55 years * BMI (body mass index): 18-28 kg/m2 * Study participants considered to be healthy * FOR TRIAL PART 2, THE FOLLOWING APPLIES: * Gender: male or female of no childbearing potential * Age: 18-65 years * T...

Countries:Germany
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