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biphasic human insulin 30

Phase 4

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Mar 1, 2017

biphasic human insulin 30 development status

Highest phase Phase 4 (NCT01487798)
Phase scored for NVOPhase 1
Registered trials 12 across 1 sponsor since Nov 2008

biphasic human insulin 30 target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as biphasic human insulin, biphasic human insulin 50

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment79

FDA Designations

No designations recorded

biphasic human insulin 30 clinical trials

biphasic human insulin 30 · 2 trials · 2 indications

Phase 1 2
NCT01486888Bioequivalence of Two Mixtard® 30 Formulations in Healthy SubjectsDiabetes
COMPLETED45 Analytics
NCT01620450Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy JapaneseDiabetes
COMPLETED34 Analytics
PHASE1COMPLETED
Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects
DiabetesUnlock trial analytics
PHASE1COMPLETED
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the serum insulin concentration-time curve (AUC 0-24 hours)
Maximum serum insulin concentration (Cmax)
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
From 0 to 16 hours after injection
Maximum insulin aspart concentration (Cmax IAsp)

Secondary Endpoints

Area under the serum insulin concentration-time curve (AUC 0-6 hours)
Area under the serum insulin concentration-time curve (AUC 6-24 hours)
Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Formulation AEXPERIMENTAL -
Formulation BACTIVE_COMPARATOR -
NN2000EXPERIMENTAL -
NN-X14ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
biphasic human insulin 30DRUGSingle dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive * Non-smoker, defined as no nicotine consumption for at least one year * Fasting plasma gluco...

Countries:GermanyJapan
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Competitive Landscape -Diabetes Complications 8 trials (matched to "Diabetes")

No competing companies are currently tracked in active development for Diabetes Complications.
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Frequently asked questions about biphasic human insulin 30

What is biphasic human insulin 30?

Biphasic human insulin 30 is an insulin-based therapy developed by Novo Nordisk A/S for diabetes. It is a small molecule that acts as an agonist at the insulin receptor (INSR). It is also known as biphasic human insulin and biphasic human insulin 50. It is in Phase 1 clinical development.

What is biphasic human insulin 30 used for?

Biphasic human insulin 30 is being developed for the treatment of diabetes. It is a metabolic therapy that combines insulin action through the insulin receptor. Development is at the Phase 1 stage, and it has been studied in two completed clinical trials in Japan and Germany.

What does biphasic human insulin 30 target?

Biphasic human insulin 30 targets the insulin receptor, or INSR. It acts as an agonist at this receptor, meaning it activates insulin receptor signaling. This mechanism underlies its development as a diabetes therapy. The drug is a small molecule being developed by Novo Nordisk A/S.

Who makes biphasic human insulin 30?

Biphasic human insulin 30 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this diabetes candidate. The drug is also referred to as biphasic human insulin and biphasic human insulin 50.

What phase is biphasic human insulin 30 in?

Biphasic human insulin 30 is in Phase 1 clinical development. It is investigational and has not been approved. Two Phase 1 trials have been completed, with no active trials ongoing. The completed studies enrolled a total of 79 participants and were randomized, double-blind, and active-controlled.

What clinical trials is biphasic human insulin 30 in?

Biphasic human insulin 30 has been studied in two completed Phase 1 trials. NCT01620450 compared insulin aspart produced by two processes in healthy Japanese participants, enrolling 34. NCT01486888 assessed bioequivalence of two Mixtard 30 formulations in healthy subjects in Germany, enrolling 45. Both trials are completed.

Is biphasic human insulin 30 the same as biphasic human insulin 50?

Biphasic human insulin 30 is also known as biphasic human insulin and biphasic human insulin 50. These names refer to the same Novo Nordisk A/S diabetes program. The drug targets the insulin receptor (INSR) as an agonist and is in Phase 1 development.