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Also known as biphasic insulin aspart 30, biphasic insulin aspart 70, biphasic insulin aspart 50
biphasic insulin as · 27 trials · 4 indications
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
| Arm | Type | Description |
|---|---|---|
| BIAsp 50-50-30 | EXPERIMENTAL | Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin |
| BIAsp 30-30 | ACTIVE_COMPARATOR | Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin |
| BIAsp 30 | EXPERIMENTAL | - |
| BIAsp | EXPERIMENTAL | - |
| BHI | EXPERIMENTAL | - |
| BIAsp 50 or 70 | EXPERIMENTAL | - |
| BHI 30 | ACTIVE_COMPARATOR | - |
| BIAsp 70 | EXPERIMENTAL | - |
| BIAsp 70 + BIAsp 50 | EXPERIMENTAL | - |
| Treatment period 1 | EXPERIMENTAL | - |
| Treatment period 2 | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| BIAsp 50 | EXPERIMENTAL | - |
| IAsp | ACTIVE_COMPARATOR | - |
| Formulation 1 | EXPERIMENTAL | - |
| Formulation 2 | ACTIVE_COMPARATOR | - |
| Formulation A | EXPERIMENTAL | - |
| Formulation B | EXPERIMENTAL | - |
| Dosing visit 1 | EXPERIMENTAL | - |
| Dosing visit 2 | EXPERIMENTAL | - |
| BIAsp 70 clinical trial formulation | EXPERIMENTAL | - |
| BIAsp 70 final formulation | EXPERIMENTAL | - |
| BIAsp 50 final formulation | EXPERIMENTAL | - |
| Insulin aspart | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| biphasic insulin aspart 30 | DRUG | Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner |
| metformin | DRUG | Tablets, 500 - 2000 mg, once, twice or three times daily |
| biphasic insulin aspart 50 | DRUG | Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch |
| biphasic human insulin 50 | DRUG | Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner |
| biphasic insulin aspart 70 | DRUG | Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\^2 will receive BIAsp 70 |
| biphasic human insulin 30 | DRUG | Administered subcutaneously (s.c., under the skin), twice a day |
| insulin glargine | DRUG | - |
| insulin glulisine | DRUG | - |
| insulin aspart | DRUG | A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between |
Inclusion Criteria: * Type 2 diabetes * Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months * HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive) * FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L * BMI (Bod...
Biphasic insulin aspart is used to treat diabetes, including type 2 diabetes. It is a biphasic insulin product that combines rapid-acting and intermediate-acting insulin components in a single formulation. Clinical studies have evaluated it in people with type 2 diabetes as well as in healthy volunteers for pharmacokinetic and pharmacodynamic characterization.
Biphasic insulin aspart targets INSR, the insulin receptor, where it acts as an agonist. By binding and activating the insulin receptor, it produces the metabolic effects of insulin, including glucose uptake and lowering of blood glucose. Its biphasic profile is designed to provide both a rapid onset and a longer duration of insulin action.
Biphasic insulin aspart is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor behind the clinical development program for this biphasic insulin product across its different formulations, including biphasic insulin aspart 30, 50, and 70.
Biphasic insulin aspart is in Phase 3 clinical development. Its trial record includes 27 completed studies spanning Phase 1 through Phase 3, with no active trials currently listed. The Phase 3 program has evaluated safety and efficacy in subjects with type 2 diabetes.
Completed trials include NCT01650129, a Phase 3 safety and efficacy study of biphasic insulin aspart 50 in type 2 diabetes in Japan, and NCT01697618, a Phase 2 pharmacokinetics, pharmacodynamics, and safety study in type 2 diabetes. Phase 1 studies include NCT01707160 and NCT01620437, both conducted in healthy volunteers.
Yes, biphasic insulin aspart 30 is one formulation of biphasic insulin aspart, along with biphasic insulin aspart 50 and biphasic insulin aspart 70. The numbers refer to the proportion of the rapid-acting insulin aspart component in the mixture, so these names describe different biphasic formulations of the same insulin aspart product.