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Actrapid

Phase 3

Severe Sepsis | Small molecule | Infectious Disease |Novo Nordisk A/S|Last Updated: Feb 11, 2016

Target and mechanism

ModalitySmall molecule

Also known as Actrapid® (Insulin)

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Actrapid · 1 trial · 2 indications

Phase 3 1
NCT00135473Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)Severe Sepsis
COMPLETED600 Analytics
PHASE3COMPLETED
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
Severe Sepsis
NCT00135473600
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Study Endpoints

Primary Endpoints

Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Secondary Endpoints

Frequency of acute kidney failure
Time until hemodynamic stabilization
Frequency of therapy with vasopressors (in days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Interventions

NameTypeDescription
10% Hemohes® (10% Hydroxyethyl starch)DRUG -
Sterofundin® (Ringer lactate solution)DRUG -
Actrapid® (Insulin)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission Exclusion Criter...

Countries:Germany
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