Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Faster Aspart · 3 trials · 3 indications
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 (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.
pmol·h/L
Calculated based on insulin aspart measured in blood.
| Arm | Type | Description |
|---|---|---|
| Faster aspart | EXPERIMENTAL | 4 daily injections of faster aspart given with insulin degludec and with or without metformin |
| Insulin aspart | ACTIVE_COMPARATOR | 4 daily injections of insulin aspart given with insulin degludec and with or without metformin |
| NovoRapid® | ACTIVE_COMPARATOR | Subjects 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®) | EXPERIMENTAL | Participants 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 aspart | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| Faster aspart | DRUG | Administered s.c. (subcutaneously, under the skin) for 16 weeks |
| Insulin aspart | DRUG | Administered s.c. (subcutaneously, under the skin) for 16 weeks |
| Insulin degludec | DRUG | Administered s.c. (subcutaneously, under the skin) for 16 weeks |
| Novo Rapid | DRUG | Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector. |
| Insulin aspart (NovoRapid®) | DRUG | An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal. |
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...
Faster Aspart is being developed for the treatment of diabetes, including type 1 diabetes and type 2 diabetes. It is a rapid-acting insulin formulation intended to improve post-meal glucose control. The drug is currently in clinical development and has been studied in adult and pediatric patients with diabetes.
Faster Aspart is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVO. Novo Nordisk is a leader in diabetes care and has conducted multiple clinical trials of Faster Aspart in various populations.
Faster Aspart is in Phase 1 clinical development according to the overall program status. However, individual trials have been conducted in Phase 1 and Phase 3 settings. The drug is investigational and has not been approved by the FDA for any indication.
Faster Aspart has been evaluated in completed clinical trials including NCT04698018, a Phase 1 study in Chinese people with type 1 or type 2 diabetes; NCT04588259, a Phase 3 comparison with insulin aspart in Chinese people with diabetes; and NCT03407599, a Phase 1 pharmacokinetic trial in children, adolescents, and adults with type 1 diabetes.
Yes, Faster Aspart is also known as fast-acting insulin aspart. This alternative name has been used in trial titles such as NCT04588259, which compared fast-acting insulin aspart to insulin aspart in Chinese people with diabetes. Both names refer to the same investigational drug candidate.