NovoNorm - repaglinide

What is NovoNorm?

NovoNorm is a medicine that contains the active substance repaglinide. It comes in the form of round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).

What is NovoNorm used for?

NovoNorm is used in patients with type 2 diabetes (non-insulin-dependent diabetes). NovoNorm is used in combination with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) can no longer be controlled through diet, weight loss and exercise. NovoNorm can also be used in combination with metformin (another antidiabetic) in type 2 diabetics who are not satisfactorily controlled on metformin alone.

How is NovoNorm used?

NovoNorm is given before meals, usually up to 15 minutes before each main meal. The doses are adapted to the patients for best results. The treating physician should regularly measure the patient's blood glucose level to find the lowest effective dose. NovoNorm may also be indicated for type 2 diabetics who are usually well controlled through a diet but are temporarily unable to regulate their blood glucose.
The recommended starting dose is 0.5 mg. It may be necessary to increase this dose after one or two weeks. If patients switch to NovoNorm while they are already using another antidiabetic, the recommended starting dose is 1 mg.
NovoNorm is not recommended for patients under the age of 18 as there is no information on safety and efficacy in this age group.

How does NovoNorm work?

Type 2 diabetes is a disease caused by the pancreas not producing enough insulin to control the blood glucose level or when the body is unable to use insulin effectively. NovoNorm helps the pancreas to produce more insulin during the meal and is used to control type 2 diabetes.

How has NovoNorm been studied?

NovoNorm has been tested in 45 clinical pharmacological studies (aimed at examining how the medicine works in the body) and 16 clinical trials (aimed at examining its effects in treating patients with type 2 diabetes). A total of 2,156 patients took the drug in these studies. The most important studies compared NovoNorm to other drugs used in type 2 diabetes (glibenclamide, glipizide or gliclazide), while another study looked at the use of NovoNorm in combination with metformin. The studies measured the blood level of a a substance called glycosylated hemoglobin (HbA1c), which indicates how well the blood glucose is controlled.

What benefit has NovoNorm shown during the studies?

In all studies, NovoNorm resulted in a decrease in the level of HbA1c, indicating that the efficacy of regulating blood glucose levels was similar to that of the other comparator medicines. In the study involving the use of NovoNorm in combination to metformin, the effects of the two drugs were found to be at least additive (equivalent to the effects of the two drugs given together).
NovoNorm produced a good meal-induced insulin response within thirty minutes of dosing in patients with type 2 diabetes, resulting in a reduction in blood glucose throughout the meal. The insulin level (raised by the drug) returned normal after a meal.

What is the risk associated with NovoNorm?

The most common side effects seen with NovoNorm (seen in between 1 and 10 out of 100 patients) are hypoglycaemia (low blood glucose), abdominal pain and diarrhea. For the full list of all side effects reported with NovoNorm, see the package leaflet.
NovoNorm must not be used in people who may be hypersensitive (allergic) to repaglinide or the other ingredients of the medicine. It must not be used in patients with type 1 (insulin-dependent) diabetes who do not have any 'C-peptide' (a marker of type 1 diabetes) in their blood. NovoNorm must not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients who are also taking gemfibrozil (a medicine used to lower blood fat levels). The dosage of NovoNorm may need to be adjusted if the drug is co-administered with certain heart medications, pain relievers, asthmatics and medicines used for other conditions. The full list is available in the package leaflet.

Why has NovoNorm been approved?

The Committee for Medicinal Products for Human Use (CHMP) considered that NovoNorm's benefits for the treatment of type 2 diabetes are greater than its risks and recommended that it be given a marketing authorization for the medicine.

More information about NovoNorm

On 17 August 1998, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for NovoNorm, valid throughout the European Union. This authorization was renewed on 17 August 2003 and on 17 August 2008.
For the complete version of the NovoNorm EPAR, click here.

Last update of this summary: 07 - 2008


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