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biphasic human insulin 30

Phase 1

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

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

Clinical trial landscape

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 6 trials (matched to "Diabetes")

Frequently asked questions about biphasic human insulin 30

What is biphasic human insulin 30 used for?

Biphasic human insulin 30 is used for diabetes. It is a small molecule being developed by Novo Nordisk A/S. The drug is currently in Phase 1 clinical development, with two completed trials that included healthy subjects and individuals with diabetes.

Who makes biphasic human insulin 30?

Novo Nordisk A/S (ticker: NVO) is developing biphasic human insulin 30. The company is conducting clinical trials for this diabetes treatment, which is currently in Phase 1 development.

What phase is biphasic human insulin 30 in?

Biphasic human insulin 30 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed two Phase 1 trials. The trials were randomized, double-blind, and active-controlled, with a total enrollment of 79 participants.

What clinical trials is biphasic human insulin 30 in?

Biphasic human insulin 30 has two completed Phase 1 trials: NCT01486888, a bioequivalence study of two Mixtard 30 formulations in healthy subjects in Germany, and NCT01620450, comparing insulin aspart produced by current and NN2000 processes in healthy Japanese males.

Is biphasic human insulin 30 the same as Mixtard 30?

Biphasic human insulin 30 is associated with Mixtard 30, as one clinical trial (NCT01486888) evaluated the bioequivalence of two Mixtard 30 formulations. The drug is being developed by Novo Nordisk for diabetes and is currently in Phase 1.