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Insulin degludec is a basal insulin for once-daily SC administration at any time of the day, preferably at the same time every day.
The potency of insulin analogs, including insulin degludec, is expressed in units (U). One (1) unit of insulin degludec corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine or 1 unit of insulin detemir.
In patients with type 2 DM, insulin degludec can be administered alone, in combination with oral anti-diabetic medicinal products as well as in combination with bolus insulin (see Pharmacology: Pharmacodynamics).
In type 1 DM, insulin degludec must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
Insulin degludec is to be dosed in accordance with the individual patient's needs. It is recommended to optimize glycemic control via dose adjustment based on fasting plasma glucose. As with all insulin products adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Insulin degludec 100 units/mL: The needed dose is dialed in units. With insulin degludec 100 units/mL a dose of 1-80 units/injection, in steps of 1 unit, can be administered.
The dose counter shows the number of units.
Flexibility in Dosing Time: On occasions when administration at the same time of the day is not possible, insulin degludec allows for flexibility in the timing of insulin administration (see Pharmacology: Pharmacodynamics). A minimum of 8 hrs between injections should always be ensured.
Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
Type 2 DM: Recommended Daily Starting Dose: 10 units followed by individual dosage adjustments.
Type 1 DM: Insulin degludec is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments.
Transfer from Other Insulin Medicinal Products: Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant anti-diabetic treatment may need to be adjusted.
Type 2 DM: For patients with type 2 diabetes taking basal, basal-bolus, premix or self-mixed insulin therapy, changing the basal insulin to insulin degludec can be done unit-to-unit based on the previous basal insulin dose followed by individual dosage adjustments.
Type 1 DM: For most patients with type 1 diabetes, changing the basal insulin to insulin degludec can be done unit-to-unit based on the previous basal insulin dose with subsequent individual dosage adjustments. For patients with type 1 diabetes transferring from twice-daily basal insulin or having HbA1c <8% at the time of transfer, the dose of insulin degludec needs to be determined on an individual basis. Dose reduction needs to be considered followed by individual dosage adjustment based on the glycemic response.
Special Populations: Elderly (≥65 years): Insulin degludec can be used in elderly patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacology: Pharmacokinetics).
Renal and Hepatic Impairment: Insulin degludec can be used in renal and hepatic impaired patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacology: Pharmacokinetics).
Administration: Insulin degludec is for SC use only. It must not be administered IV as it may result in severe hypoglycemia. It must not be administered IM as it may change the absorption and it must not be used in insulin infusion pumps.
Insulin degludec is administered SC by injection in the thigh, the upper arm or the abdominal wall. Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy. Insulin degludec comes in a pre-filled pen designed to be used with NovoFine or NovoTwist injection needles.
The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit.
