Insulin degludec (a long-acting human insulin analog) and insulin aspart (a rapid-acting human insulin analog) indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus

Combination Insulin

Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.

The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

This is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart.

This is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements.

Patients with type 2 diabetes mellitus: The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments.

Patients with type 1 diabetes mellitus: The recommended starting dose is 60-70% of the total daily insulin requirements. This is to be used once-daily at meal-time in combination.

This can be administered once- or twice-daily with the main meal(s). When needed, the patient can change the time of administration as long as this insulin is dosed with the largest meal when taken once daily.

In patients with type 2 diabetes mellitus this insulin can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin.

In type 1 diabetes mellitus, this insulin is combined with short-/rapid-acting insulin at the remaining meals.

There are no known drug interactions and none well documented.

Hypersensitivity to the active substances or to any of the excipients.

Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous nsulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production.

Hypoglycaemia: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.

Hyperglycaemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.

Eye disorder: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.

Avoidance of accidental mix-ups: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this and other insulin products.

Older patients (> 65 years old): Insulin Degludec & Insulin Aspart Premixed can be used in older patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.

Paediatric population: This Insulin has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have not been investigated in children and adolescents.

Renal and hepatic impairment: This insulin can be used in renal and hepatic impaired patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.