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Faster Aspart

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Dec 4, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment354
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04588259Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With DiabetesPHASE3 COMPLETED 331 — — Oct 9, 2020Aug 5, 2022Dec 4, 202540 China, Hong Kong
NCT04698018A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 DiabetesPHASE1 COMPLETED 23 — — Apr 20, 2021Jul 22, 2022Dec 4, 20253 Germany, Hong Kong
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Study Endpoints
Primary Endpoints
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])
Baseline (week 0), week 16

Change from baseline (week 0) in HbA1c (%) as evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])
Baseline (week 0), week 16

Change from baseline (week 0) in HbA1c (mmol/mol) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)

pmol·h/L

Secondary Endpoints
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)
Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)
Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline (week 0), week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Faster aspartEXPERIMENTAL4 daily injections of faster aspart given with insulin degludec and with or without metformin
Insulin aspartACTIVE_COMPARATOR4 daily injections of insulin aspart given with insulin degludec and with or without metformin
NovoRapid®ACTIVE_COMPARATORSubjects will receive 2 injections of a single dose of NovoRapid® at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.
Interventions
NameTypeDescription
Faster aspartDRUGAdministered s.c. (subcutaneously, under the skin) for 16 weeks
Insulin aspartDRUGAdministered s.c. (subcutaneously, under the skin) for 16 weeks
Insulin degludecDRUGAdministered s.c. (subcutaneously, under the skin) for 16 weeks
Novo RapidDRUGAdministered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Male or female, age above or equal to 18 years at the time of signing informed consent * Diagnosed with Diabetes Mellitus, Type 1 (T1DM) at least or equal to 1 year prior to screening or diagnosed with Diabetes Mellitus, Type 2 (T2DM) at least or equal to 5 years prior to scre...

Countries:ChinaHong KongGermany
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