Active Ingredient: Insulin detemir
Insulin detemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
0.1 - 0.2 [iU] per kg of body weight
From 0.1 To 0.2 [iU] per kg of body weight once every day
The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units. 1 unit insulin detemir corresponds to 1 international unit of human insulin.
Insulin detemir can be used alone as the basal insulin or in combination with bolus insulin. It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
When insulin detemir is used in combination with oral antidiabetic medicinal products or when added to GLP-1 receptor agonists it is recommended to use insulin detemir once daily, initially at a dose of 0.1–0.2 units/kg or of 10 units in adult patients. The dose of insulin detemir should be titrated based on the individual patient’s needs.
When a GLP-1 receptor agonist is added to insulin detemir, it is recommended to reduce the dose of insulin detemir by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually.
For individual dose adjustments, the following two titration guidelines are recommended for adults:
Adult type 2 diabetes titration guideline:
| Average pre-breakfast SMPG* | Insulin detemir dose adjustment |
|---|---|
| >10,0 mmol/l (180 mg/dl) | +8 units |
| 9,1-10,0 mmol/l (163–180 mg/dl) | +6 units |
| 8,1-9,0 mmol/l (145–162 mg/dl) | +4 units |
| 7,1-8,0 mmol/l (127–144 mg/dl) | +2 units |
| 6,1-7,0 mmol/l (109–126 mg/dl) | +2 units |
| 4,1-6,0 mmol/l (73–108 mg/dl) | No change in dose (target) |
| If one SMPG measurement | |
| 3,1-4,0 mmol/l (56–72 mg/dl) | -2 units |
| <3,1 mmol/l (<56 mg/dl) | -4 units |
Adult type 2 diabetes simple self-titration guideline:
| Average pre-breakfast SMPG* | Insulin detemir dose adjustment |
|---|---|
| >6,1 mmol/l (>110 mg/dl) | +3 units |
| 4,4-6,1 mmol/l (80-110 mg/dl) | No change in dose (target) |
| <4,4 mmol/l (<80 mg/dl) | -3 units |
When insulin detemir is used as part of a basal-bolus insulin regimen, insulin detemir should be administered once or twice daily depending on patients' needs. The dose of insulin detemir should be adjusted individually.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
When adjusting dose in order to improve glucose control, patients should be advised to be aware of signs of hypoglycaemia.
Insulin detemir is a long-acting insulin analogue used as a basal insulin. Insulin detemir is for subcutaneous administration only. Insulin detemir must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should also be avoided. Insulin detemir is not to be used in insulin infusion pumps.
Insulin detemir is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. The injection can be given at any time during the day, but at the same time each day. For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
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