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human regular insulin

Phase 1

Diabetes Mellitus | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Aug 9, 2007

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00513643Metabolic Effect of Insulin Aspart and Human Insulin in Different DosesPHASE1 COMPLETED 16 — — Apr 1, 2002Jun 1, 2002Aug 9, 20071 Germany
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Study Endpoints
Primary Endpoints
AUC GIR 360-720 min
at each dosing (6 times during the trial)
Secondary Endpoints
PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min
at each dosing visit (6 times during the study)
PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR
at each dosing visit (6 times during the study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL6 U insulin aspart
2EXPERIMENTAL12 U insulin aspart
3EXPERIMENTAL24 U insulin aspart
4ACTIVE_COMPARATOR6 IU human regular insulin
5ACTIVE_COMPARATOR12 IU human regular insulin
6ACTIVE_COMPARATOR24 IU human regular insulin
Interventions
NameTypeDescription
insulin aspartDRUG6, 12, 24 U s.c.
human regular insulinDRUG6, 12 and 24 IU sc
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Signed informed consent obtained before any trial-related activities * Healthy subjects between 18 and 45 years inclusive * Considered generally healthy upon completion of medical history and physical examination * Body mass index (BMI) \< 27 kg/m2 * HbA1c \< 6,1 % * Non-smoke...

Countries:Germany
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