Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
human soluble insulin · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Basal/bolus regimen 1 | EXPERIMENTAL | - |
| Basal/bolus regimen 2 | ACTIVE_COMPARATOR | - |
| insulin aspart | EXPERIMENTAL | - |
| human insulin | ACTIVE_COMPARATOR | - |
| Insulin detemir 60 pmol/kg/min | EXPERIMENTAL | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Insulin detemir 120 pmol/kg/min | EXPERIMENTAL | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Human insulin 6 pmol/kg/min | ACTIVE_COMPARATOR | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Name | Type | Description |
|---|---|---|
| insulin detemir | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily |
| insulin aspart | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
| insulin NPH | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily |
| human soluble insulin | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
Inclusion Criteria: * Type 1 diabetes for at least 12 months * Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months * BMI below or equal to 35 kg/m\^2 * HbA1c below or equal to 12% Exclusion Criteria: * Proliferative retinopathy or maculopathy req...
| 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 |
Human soluble insulin is used for the treatment of diabetes, including type 1 diabetes. It is a short-acting insulin that helps control blood glucose levels. In clinical trials, it has been studied in combination with other insulins, such as insulin NPH, for managing type 1 diabetes in adult patients.
Human soluble insulin is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. Novo Nordisk is conducting clinical trials to evaluate the safety and efficacy of this insulin in patients with type 1 diabetes.
Human soluble insulin is in Phase 3 clinical development for the treatment of diabetes. It has completed three clinical trials, including two Phase 3 studies and one Phase 1 study. The drug is investigational and has not been approved by regulatory authorities based on the available data.
Human soluble insulin has been studied in three completed clinical trials. NCT01486940 compared insulin detemir plus insulin aspart with insulin NPH plus human soluble insulin in type 1 diabetes. NCT01707134 evaluated the safety and efficacy of insulin aspart in type 1 diabetes. NCT02162407 investigated the relationship between pharmacodynamic and interstitial concentration for insulin detemir and human insulin.
No, human soluble insulin is not the same as insulin NPH. In clinical trials, human soluble insulin is used as a comparator or component in combination regimens. For example, NCT01486940 compared insulin detemir plus insulin aspart with insulin NPH plus human soluble insulin, indicating they are distinct insulin formulations.