Insulin Aspart 30% + Insulin Aspart Protamine 70%
Overview
Insulin Aspart 30% + Insulin Aspart Protamine 70% is a biphasic premixed insulin analogue formulation combining 30 percent soluble insulin aspart with 70 percent protamine-crystallised insulin aspart. The soluble insulin aspart component is rapidly absorbed following subcutaneous injection and provides early glucose-lowering action to control postprandial blood sugar rises. The protamine-bound component delays absorption, producing an intermediate-acting insulin effect that supports basal glycemic control between meals. Together, these components enhance peripheral glucose uptake and suppress hepatic glucose production, addressing both mealtime and background insulin requirements. This formulation is designed to simplify insulin therapy by integrating prandial and basal insulin coverage in a single injection and is commonly used in routine diabetes management for patients who require predictable insulin action with fewer daily injections.
Background and Date of Approval
Insulin aspart was developed as a rapid-acting insulin analogue to more closely mimic physiological insulin secretion following meals. It received approval from the United States Food and Drug Administration in 2000. Premixed formulations combining insulin aspart with protamine-crystallised insulin aspart, including the 30 percent and 70 percent combination, were approved by the United States Food and Drug Administration on 1 November 2001 for the treatment of diabetes mellitus. Similar approvals were subsequently granted by the European Medicines Agency and other regulatory authorities worldwide. These approvals were based on clinical trial programs demonstrating effective glycemic control with an acceptable safety profile in patients with type 1 and type 2 diabetes mellitus.
Uses
Insulin Aspart 30% + Insulin Aspart Protamine 70% is indicated for the treatment of patients with type 1 diabetes mellitus and type 2 diabetes mellitus who require insulin therapy to achieve adequate glycemic control. It is particularly suitable for individuals who benefit from both rapid postprandial glucose reduction and intermediate basal insulin coverage in a fixed combination. The formulation is commonly used once or twice daily before meals as part of a comprehensive diabetes management strategy that includes dietary planning, physical activity, and regular blood glucose monitoring.
Administration
This premixed insulin is administered by subcutaneous injection into the abdomen, thigh, buttocks, or upper arm, with careful rotation of injection sites to reduce the risk of lipodystrophy. The suspension should be gently mixed until uniformly cloudy before administration. It is typically injected within 15 minutes before a meal to align the rapid-acting insulin effect with postprandial glucose excursions. Dosing is individualised based on patient body weight, insulin sensitivity, meal patterns, activity level, and blood glucose monitoring results, with adjustments made under medical supervision.
Side Effects
The most common side effect associated with Insulin Aspart 30% + Insulin Aspart Protamine 70% is hypoglycemia, which may present with symptoms such as sweating, tremors, hunger, dizziness, headache, or confusion. Injection site reactions including redness, swelling, itching, or pain may occur. Weight gain can be observed as glycemic control improves. Rash, pruritus, or peripheral edema may also occur in some patients. These effects vary among individuals and are generally manageable with appropriate dose adjustment and monitoring.
Warnings
Serious adverse events include severe hypoglycemia, which may lead to seizures, loss of consciousness, or death if not promptly treated. Hypokalemia may occur due to insulin-mediated shifts of potassium into cells and can result in cardiac rhythm disturbances. Rare but serious allergic reactions, including anaphylaxis, have been reported. Fluid retention and worsening of heart failure may occur, particularly when insulin is used with certain antidiabetic medications. This formulation should not be used during episodes of hypoglycemia.
Precautions
Baseline assessment of glycemic control, renal function, and hepatic function is recommended prior to initiating therapy. Changes in diet, physical activity, body weight, stress, or intercurrent illness can significantly affect insulin requirements. Concomitant medications such as beta-blockers, corticosteroids, alcohol, and other glucose-lowering agents may alter insulin response or mask symptoms of hypoglycemia. Regular blood glucose monitoring is essential to guide dose adjustments and ensure safe use.
Expert Tips
Patient selection should consider lifestyle regularity, meal timing, and ability to recognise hypoglycemia. Proper education on injection technique, correct resuspension of the premixed insulin, and injection site rotation is critical for consistent dosing. Dose titration should be gradual and based on structured blood glucose monitoring data. Patients should be advised to carry fast-acting carbohydrates to manage hypoglycemia promptly. Ongoing collaboration between healthcare professionals supports adherence and optimises long-term glycemic outcomes.