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Actrapid

Phase 3

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

Actrapid development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Aug 2007

Actrapid target and mechanism

ModalitySmall molecule

Also known as Actrapid® (Insulin), soluble human 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

Actrapid clinical trials

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 SepsisUnlock trial analytics

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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Frequently asked questions about Actrapid

What is Actrapid used for in severe sepsis?

Actrapid is being studied as an insulin therapy in severe sepsis and septic shock. It was evaluated in the Phase 3 VISEP trial, which examined intensive insulin therapy alongside volume substitution in critically ill adults with severe sepsis. Actrapid is not approved for severe sepsis and remains investigational for this indication.

Who makes Actrapid?

Actrapid is developed and manufactured by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the Phase 3 VISEP trial that evaluated Actrapid in severe sepsis.

What phase is Actrapid in for severe sepsis?

Actrapid is in Phase 3 development for severe sepsis. The VISEP trial, registered as NCT00135473, was a Phase 3 study that has been completed. Actrapid is investigational for severe sepsis and is not approved for that indication.

What clinical trials is Actrapid in for severe sepsis?

Actrapid was evaluated in the VISEP trial, NCT00135473, titled Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis. The Phase 3 trial enrolled 600 adults aged 18 years and older in Germany and has been completed. It was randomized but not double blinded, with an uncontrolled design.

Is Actrapid the same as Actrapid (Insulin)?

Yes. Actrapid and Actrapid (Insulin) refer to the same product from Novo Nordisk A/S. Actrapid is an insulin therapy, and the alternative name Actrapid (Insulin) is used interchangeably in reference to the same drug.