Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIASP
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...
Biphasic insulin aspart is used to treat diabetes, including type 1 and type 2 diabetes mellitus. It is a biphasic insulin formulation studied in adults aged 18 years and older. Clinical trials have evaluated its use in both type 1 and type 2 diabetes populations across multiple countries.
Biphasic insulin aspart targets the insulin receptor (INSR) as an agonist. By activating INSR, it supports glucose uptake and helps manage blood glucose levels in people with diabetes. This receptor is the primary target for insulin-based therapies.
Biphasic insulin aspart is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company has sponsored the clinical development program for this insulin formulation.
Biphasic insulin aspart is in Phase 3 clinical development. All 15 registered trials have been completed, with no active trials currently listed. The program has enrolled a total of 4,332 participants across its studies.
Biphasic insulin aspart has been studied in 15 completed Phase 3 trials. Examples include NCT01467375 in type 2 diabetes, NCT01467323 in type 1 or type 2 diabetes, NCT00617565 in type 1 or type 2 diabetes, and NCT00612599 comparing biphasic insulin aspart 50 to biphasic insulin aspart 70 in type 2 diabetes.