Recent Updates
Recently added Catalysts

Insulin aspart

Phase 4FDA approved

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

Insulin aspart development status

FDA approval on record Sep 25, 2015
Approval holderNovo
ApplicationBLA203313
Highest phase Phase 4 (NCT00657943)
Phase scored for NVOPhase 3
Registered trials 167 across 16 sponsors since Jul 2003

Insulin aspart target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as Insulin aspart (NovoRapid®)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials14
Total Enrollment1,959

FDA Designations

No designations recorded

Insulin aspart clinical trials

Insulin aspart · 14 trials · 5 indications

Phase 3 6Phase 1 8
NCT00888732A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human InsulinDiabetes Mellitus, Type 1
COMPLETED24 Analytics
NCT00097071Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and AdolescentsDiabetes
COMPLETED299 Analytics
NCT00604656Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 DiabetesDiabetes
COMPLETED241 Analytics
NCT00725036Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 DiabetesDiabetes
COMPLETED305 Analytics
NCT00832182Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 DiabetesDiabetes
COMPLETED75 Analytics
NCT01707134Safety and Efficacy of Insulin Aspart in Subjects With Type 1 DiabetesDiabetes
COMPLETED753 Analytics
PHASE3COMPLETED
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
Diabetes Mellitus, Type 1Unlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
DiabetesUnlock trial analytics
PHASE3COMPLETED
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
DiabetesUnlock trial analytics
PHASE3COMPLETED
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes
DiabetesUnlock trial analytics
PHASE3COMPLETED
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
DiabetesUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.
12 hours following a standard test meal (breakfast)
HbA1c
After 16 weeks treatment
Insulin aspart antibodies
After 6 months treatment
Long term pulmonary safety profiles
during treatment
Number of hypoglycemic episodes and adverse events
at 3 and 6 months and at the end of the trial
Number of hypoglycaemic events
Area under curve insulin aspart measured in serum
During a maximum of 8 hours
Maximum concentration of insulin aspart measured in serum
During a maximum of 8 hours
Clearance at steady state (CLss) for IV treatment group
from 180 min to 240 min
Area under the curve (AUC) for IM treatment group
from 0 to 480 min after intramuscular injection
Area under the insulin aspart bolus concentration-time curve
From 0 and up to 12 hours post bolus dose administration
Maximum plasma concentration (Cmax) of insulin aspart
From 0 and up to 12 hours post bolus dose administration
Area under the curve (AUC) in the interval of 0-6 hours
Cmax, maximum concentration
Variation in morning FPG
Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge
Area under the Curve (AUC) (insulin aspart)
Area under the curve (AUC)
Area under the glucose infusion rate curve

Secondary Endpoints

AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
12 hours following a standard test meal (breakfast)
AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin
12 hours following a standard test meal (breakfast)
tmaxins: Time to maximum serum insulin aspart/human insulin concentration
12 hours following a standard test meal (breakfast)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin therapyEXPERIMENTALInsulin Aspart, Biphasic Insulin Aspart 70 and 50 \& Fast-acting Human Insulin
Insulin aspart and neutral protamine Hagedorn insulinEXPERIMENTAL -
insulin aspartEXPERIMENTAL -
human insulinACTIVE_COMPARATOR -
3 mm needleEXPERIMENTAL -
3.5 mm needleEXPERIMENTAL -
4 mm needleACTIVE_COMPARATOR -
Treatment sequence 1 - IM treatment groupEXPERIMENTAL -
Treatment sequence 2 - IM treatment groupEXPERIMENTAL -
Treatment sequence 1 - IV treatment groupEXPERIMENTAL -
Treatment sequence 2 - IV treatment groupEXPERIMENTAL -
Insulin aspart 100U/mLACTIVE_COMPARATOR -
Insulin aspart 200U/mLEXPERIMENTAL -
U200EXPERIMENTAL -
U100ACTIVE_COMPARATOR -
NN2000EXPERIMENTAL -
IAspACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Insulin Aspart, BIAsp 70, BIAsp50, Human InsulinDRUG0.2 U/IU/kg subcutaneous injection, single dose
insulin lisproDRUG -
insulin aspartDRUG -
inhaled human insulinDRUG -
insulin NPHDRUG -
human soluble insulinDRUGInjected subcutaneously (s.c, under the skin) as meal time insulin
insulin humanDRUGAt the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
pumpDEVICE -
insulin glargineDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Informed consent obtained before any trial-related activities. * Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis. * Insulin treatment of any regime for more than one year at time of inclusion. * Total insulin demand ≥ 0,4 U/...

Countries:DenmarkUnited StatesCzechiaGermanyHungaryItalyPolandAustraliaCroatiaIsraelRussiaSloveniaAustriaFinlandNorwaySwedenSwitzerlandUnited KingdomJapanSouth Africa
Unlock Eligibility Criteria

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

No competing companies are currently tracked in active development for Diabetes Complications.
Unlock Competitive Intelligence

Frequently asked questions about Insulin aspart

What is insulin aspart used for?

Insulin aspart is used to treat diabetes, including type 1 diabetes mellitus. It is a rapid-acting insulin analog given to lower blood glucose. The clinical program covers both type 1 diabetes and broader diabetes populations, with trials enrolling adults aged 18 years and older.

How does insulin aspart work?

Insulin aspart works as an agonist at INSR, the insulin receptor. By binding and activating this receptor, it triggers the signaling that drives glucose uptake into cells and lowers blood glucose, mimicking the action of endogenous human insulin.

Who makes insulin aspart?

Insulin aspart is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor behind the clinical trial program for the asset across its diabetes indications.

What phase is insulin aspart in?

Insulin aspart is in Phase 3 development. Its trial record includes 13 studies, all of which are completed, with no active trials listed. The completed studies span Phase 1 pharmacokinetic and bioequivalence work through Phase 3 safety and efficacy testing.

What clinical trials is insulin aspart in?

Insulin aspart has been studied in completed trials including NCT01707134, a Phase 3 safety and efficacy study in type 1 diabetes with 753 participants, and NCT02594033, a Phase 1 pharmacokinetic needle-feature study. Phase 1 bioequivalence and formulation comparison trials include NCT01530048 and NCT01698697.

Is insulin aspart the same as NovoRapid or BIAsp 70?

Insulin aspart is also known as NovoRapid, and it is referenced under names including BIAsp 70, BIAsp50, and human insulin. These alternative names all point to the same insulin aspart asset developed by Novo Nordisk.