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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

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment354

FDA Designations

No designations recorded

Clinical trial landscape

Faster Aspart · 3 trials · 3 indications

Phase 3 1Phase 1 2
NCT04588259Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With DiabetesDiabetes Mellitus, Type 1
COMPLETED331 Analytics
PHASE3COMPLETED
Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

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

AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
0-12 hours

Calculated based on insulin aspart measured in blood.

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.
Faster aspart followed by insulin aspart (NovoRapid®)EXPERIMENTALParticipants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
Insulin aspart (NovoRapid®) followed by faster aspartEXPERIMENTALParticipants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.

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.
Insulin aspart (NovoRapid®)DRUGAn injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Faster Aspart

What is Faster Aspart used for?

Faster Aspart is an investigational fast-acting insulin aspart being studied for the treatment of Diabetes Mellitus, Type 1 and Type 2 diabetes. It is developed by Novo Nordisk A/S and is currently in Phase 3 clinical development for these metabolic conditions.

Who makes Faster Aspart?

Faster Aspart is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with type 1 and type 2 diabetes.

What phase is Faster Aspart in?

Faster Aspart is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating diabetes.

What clinical trials is Faster Aspart in?

Faster Aspart has been studied in several completed clinical trials, including NCT03407599, a Phase 1 trial in children, adolescents, and adults with type 1 diabetes, and NCT04588259, a Phase 3 trial comparing it to insulin aspart in Chinese people with diabetes. All trials are completed.

How does Faster Aspart work?

Faster Aspart is a fast-acting form of insulin aspart, designed to control blood sugar levels in people with diabetes. It works by replacing the insulin that the body normally produces, helping to regulate glucose metabolism and manage hyperglycemia in patients with type 1 and type 2 diabetes.