Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Faster-acting insulin aspart · 24 trials · 4 indications
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product.
Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Change from baseline in HbA1c after 26 weeks of randomised treatment.
Calculated based on insulin aspart measured in serum
| Arm | Type | Description |
|---|---|---|
| Faster aspart + insulin degludec with or without metformin | EXPERIMENTAL | - |
| NovoRapid/NovoLog + insulin degludec with or without metformin | ACTIVE_COMPARATOR | - |
| Faster-acting insulin aspart CSII | EXPERIMENTAL | - |
| NovoRapid® CSII | ACTIVE_COMPARATOR | - |
| Meal-time faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| Meal-time NovoRapid® (insulin aspart) and insulin degludec | ACTIVE_COMPARATOR | - |
| Post-meal faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| Mealtime faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| Mealtime NovoRapid® and insulin degludec | ACTIVE_COMPARATOR | - |
| Postmeal faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| FIAsp | EXPERIMENTAL | The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period |
| Insulin Aspart | ACTIVE_COMPARATOR | The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period |
| FIAsp and basal insulin + metformin | EXPERIMENTAL | Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. |
| Basal insulin + metformin | ACTIVE_COMPARATOR | Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. |
| Faster-acting insulin aspart (FIAsp) | EXPERIMENTAL | Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication. |
| Meal time FIAsp and insulin detemir | EXPERIMENTAL | - |
| Meal time insulin aspart and insulin detemir | ACTIVE_COMPARATOR | - |
| Post meal FIAsp and insulin detemir | EXPERIMENTAL | - |
| Faster aspart followed by insulin aspart | EXPERIMENTAL | Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery |
| Insulin aspart followed by faster aspart | EXPERIMENTAL | Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery |
| Faster Aspart | EXPERIMENTAL | - |
| Faster-acting insulin aspart | EXPERIMENTAL | Each subject will be allocated to two treatments (in random sequence). |
| NovoRapid® | ACTIVE_COMPARATOR | Each subject will be allocated to two treatments (in random sequence). |
| FIAsp followed by NovoRapid® | EXPERIMENTAL | Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days |
| NovoRapid® followed by Insulin aspart | ACTIVE_COMPARATOR | Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days |
| NovoRapid® followed by FIAsp | EXPERIMENTAL | Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days |
| Formulation 1 | EXPERIMENTAL | - |
| Formulation 2 | EXPERIMENTAL | - |
| Insulin aspart (NovoLog®) | ACTIVE_COMPARATOR | - |
| Formulation A | EXPERIMENTAL | - |
| Formulation B | EXPERIMENTAL | - |
| NN1218 | EXPERIMENTAL | - |
| Treatment sequence 1 | EXPERIMENTAL | - |
| Treatment sequence 2 | ACTIVE_COMPARATOR | - |
| NN1218, formulation A | EXPERIMENTAL | - |
| NN1218, formulation B | EXPERIMENTAL | - |
| NN1218, formulation C | EXPERIMENTAL | - |
| NN1218, formulation D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Faster-acting insulin aspart | DRUG | Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| Insulin aspart | DRUG | Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| Insulin degludec | DRUG | Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| Metformin | DRUG | Only participants who took metformin before the study should take metformin tablets, same dose as before the study |
| basal insulin | DRUG | Administrated subcutaneously (s.c., under the skin) once daily. |
| Insulin glargine | DRUG | Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial. |
| insulin detemir | DRUG | Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily. |
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Faster-acting insulin aspart is an investigational drug being developed for the treatment of diabetes, including type 1 diabetes. It is designed to manage blood glucose levels in patients with this condition. The drug is currently in Phase 3 clinical development and has been studied in multiple trials.
Faster-acting insulin aspart is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with diabetes.
Faster-acting insulin aspart is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug has completed 24 clinical trials, with a total enrollment of 6,969 participants, and is being studied for the treatment of diabetes.
Faster-acting insulin aspart has been studied in several clinical trials, including NCT01296438, NCT01469143, NCT02568280, and NCT03215498. These trials have investigated the drug's pharmacokinetic properties, postprandial glucose metabolism, and its effects when administered via insulin pump in patients with type 1 diabetes.
Yes, Faster-acting insulin aspart is also known as NN1218 in clinical trials. Several studies, including NCT01296438 and NCT01469143, refer to the drug as NN1218. This alternative name is used in the context of clinical research to identify the same investigational compound.