Insulin Degludec + Insulin Aspart
Overview
Insulin Degludec + Insulin Aspart is a co-formulated insulin product that combines an ultra long-acting basal insulin analogue, insulin degludec, with a rapid-acting prandial insulin analogue, insulin aspart, in a fixed ratio within a single injectable formulation. Insulin degludec forms multi-hexamers at the injection site, creating a subcutaneous depot that releases insulin slowly and predictably over an extended period, providing stable basal glucose control. Insulin aspart is rapidly absorbed following subcutaneous administration and effectively reduces postprandial blood glucose by promoting cellular glucose uptake and suppressing hepatic glucose production. The co-formulation allows both insulin components to maintain their distinct pharmacodynamic profiles without interference, enabling comprehensive glucose control with fewer injections compared to traditional basal-bolus regimens. This combination supports improved glycemic stability and treatment adherence in patients requiring both basal and prandial insulin coverage.
Background and Date of Approval
Insulin degludec was developed as an ultra long-acting basal insulin analogue and received approval from the United States Food and Drug Administration on 25 September 2015. A fixed-ratio co-formulation of insulin degludec and insulin aspart, commonly presented as a 70 percent insulin degludec and 30 percent insulin aspart combination, was approved by the FDA on the same date for the treatment of diabetes mellitus. The European Medicines Agency approved this co-formulated insulin in the year 2013 following evaluation of clinical studies demonstrating effective basal and prandial glucose control with a favourable safety profile. These approvals were supported by pivotal trials confirming non-inferior or improved glycemic outcomes compared with conventional insulin regimens, along with reduced risk of nocturnal hypoglycemia.
Uses
Insulin Degludec + Insulin Aspart is indicated for improving glycemic control in adults with type 1 diabetes mellitus and type 2 diabetes mellitus who require insulin therapy. It is particularly useful in patients who need both basal insulin coverage and rapid prandial glucose control but prefer a simplified injection regimen. The co-formulation may be used for initiation or intensification of insulin therapy in patients inadequately controlled on oral antidiabetic agents, basal insulin alone, or premixed insulin formulations. It can be incorporated into individualized treatment plans based on metabolic needs, meal patterns, and glycemic targets.
Administration
This insulin co-formulation is administered by subcutaneous injection into the abdomen, thigh, or upper arm, with rotation of injection sites to reduce the risk of local reactions and lipodystrophy. It is typically injected once or twice daily with the main meal or meals of the day to align the rapid-acting insulin aspart component with postprandial glucose rises, while insulin degludec provides continuous basal coverage. Dosing is individualized based on prior insulin exposure, current blood glucose levels, body weight, and clinical response. Regular self-monitoring of blood glucose is essential to guide dose titration and maintain safe and effective glycemic control.
Side Effects
The most commonly reported side effect of Insulin Degludec + Insulin Aspart is hypoglycemia, which may present with symptoms such as sweating, tremor, hunger, dizziness, headache, or confusion. Injection site reactions including redness, swelling, itching, or pain may occur. Weight gain can develop over time as glycemic control improves. Peripheral oedema and mild hypersensitivity reactions have also been reported. The occurrence and severity of side effects vary among individuals and are generally manageable with appropriate dose adjustments and monitoring.
Warnings
Serious adverse events include severe hypoglycemia, which can lead to seizures, loss of consciousness, or death if not promptly treated. Insulin therapy may cause hypokalemia due to intracellular potassium shifts, potentially resulting in cardiac rhythm disturbances in susceptible patients. Rare but serious systemic allergic reactions, including anaphylaxis, have been reported. Fluid retention and worsening of heart failure may occur in certain patients. This insulin combination should not be administered during episodes of hypoglycemia, and caution is required in patients with unstable insulin requirements.
Precautions
Prior to initiation of Insulin Degludec + Insulin Aspart, assessment of renal and hepatic function, glycemic status, and concurrent medications is recommended. Certain medications, including beta-blockers, corticosteroids, alcohol, diuretics, and other glucose-lowering agents, may alter insulin requirements or mask symptoms of hypoglycemia. Changes in diet, physical activity, stress levels, or the presence of intercurrent illness can significantly affect insulin needs. Patients should be educated on proper injection technique, recognition of hypoglycemia, and the importance of consistent blood glucose monitoring.
Expert Tips
When prescribing Insulin Degludec + Insulin Aspart, therapy should be tailored to the patient’s lifestyle, meal timing, and glycemic patterns. Clear counselling on injection timing relative to meals and consistent site rotation is essential for optimal efficacy. Regular review of blood glucose records facilitates safe titration and early identification of hypoglycemia. Patients should be advised to carry a fast-acting carbohydrate source for emergency management of low blood glucose. Multidisciplinary support can improve adherence and long-term treatment outcomes.