Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
biphasic insulin aspart · 15 trials · 3 indications
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
| Arm | Type | Description |
|---|---|---|
| Insulin detemir (basal insulin) | EXPERIMENTAL | Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen. |
| Insulin aspart (prandial insulin) | ACTIVE_COMPARATOR | Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen. |
| Biphasic insulin aspart 30 (biphasic insulin) | ACTIVE_COMPARATOR | Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen. |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| biphasic insulin aspart | DRUG | - |
| biphasic human insulin | DRUG | - |
| exenatide | DRUG | - |
| metformin | DRUG | - |
| insulin glargine | DRUG | - |
| insulin detemir | DRUG | Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart |
| insulin aspart | DRUG | Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir |
| pioglitazone | DRUG | - |
| insulin NPH | DRUG | - |
Inclusion Criteria: * Type 2 diabetes mellitus * Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks. * HbA1C: less than 11.0% * BMI: less than 30.0 kg/m2 Exclusion Criteria: * Total daily insulin dose: 10...
| 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 |
Biphasic insulin aspart 30 is used for diabetes. It is a premixed insulin formulation containing 30% rapid-acting insulin aspart and 70% intermediate-acting protamine-crystallized insulin aspart. It is being developed by Novo Nordisk A/S and is currently in Phase 3 clinical development for the treatment of diabetes.
Biphasic insulin aspart 30 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 this insulin formulation for the treatment of diabetes.
Biphasic insulin aspart 30 is in Phase 3 clinical development. It is an investigational drug for diabetes and has not been approved by regulatory authorities. The development program includes 54 completed clinical trials with a total enrollment of 8,362 participants.
Biphasic insulin aspart 30 has been studied in 54 completed clinical trials. Notable trials include NCT01174303, a Phase 1 study in young adults and elderly subjects with type 1 diabetes, and NCT01523041, a Phase 1 study comparing two formulations of biphasic insulin aspart 70. Other trials include NCT01527552 and NCT01620437, both Phase 1 bioequivalence studies in healthy subjects.
Biphasic insulin aspart 30 and biphasic insulin aspart 70 are different formulations of the same drug. Biphasic insulin aspart 30 contains 30% rapid-acting insulin aspart and 70% intermediate-acting insulin aspart, while biphasic insulin aspart 70 contains 70% rapid-acting and 30% intermediate-acting components. Both are being developed by Novo Nordisk for diabetes.