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biphasic insulin aspart 50
Biphasic insulin aspart 50 is a premixed insulin formulation that provides rapid-acting insulin aspart combined with intermediate-acting insulin to control blood glucose in diabetes.
Biphasic insulin aspart 50 is a premixed insulin formulation that provides rapid-acting insulin aspart combined with intermediate-acting insulin to control blood glucose in diabetes. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
At a glance
| Generic name | biphasic insulin aspart 50 |
|---|---|
| Also known as | NovoMix® 50 |
| Sponsor | Novo Nordisk A/S |
| Drug class | Insulin (premixed biphasic formulation) |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
This formulation contains 50% insulin aspart (a rapid-acting insulin analog) and 50% insulin aspart protamine suspension (intermediate-acting). The rapid component begins working within 10-20 minutes to address postprandial glucose spikes, while the intermediate component provides basal insulin coverage over several hours. Together, they mimic a more physiologic insulin secretion pattern in patients with type 1 and type 2 diabetes.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Weight gain
- Injection site reactions
- Lipodystrophy
Key clinical trials
- Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus. (PHASE3)
- Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes (PHASE4)
- Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes (PHASE3)
- Comparison of Two Formulations of Biphasic Insulin Aspart 70 (PHASE1)
- Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects (PHASE1)
- Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects (PHASE1)
- Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects (PHASE1)
- Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |