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 color: 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 food diets and exercise to lower the blood glucose (sugar) level 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. Doses are adapted to patients for best results. The treating physician should regularly measure the patient's blood glucose level to find the lowest effective dose. NovoNorm can also be indicated for type 2 diabetics who are usually well controlled through a diet, but are temporarily unable to regulate 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 because there is no information about the safety and efficacy in this age group.
How does NovoNorm work?
Type 2 diabetes is a disease caused by insufficient production of insulin by the pancreas to control the level of glucose in the blood or when the body is unable to use insulin effectively. NovoNorm helps the pancreas to produce more insulin during a meal and is used to control type 2 diabetes.
How has NovoNorm been studied?
NovoNorm has been tested in 45 clinical pharmacology studies (aimed at examining how the medicine works in the body) and 16 clinical trials (aimed at examining its effects in the treatment of patients with type 2 diabetes). A total of 2156 patients took the drug during these studies. The most important studies compared NovoNorm to other drugs used in type 2 diabetes (glibenclamide, glipizide or gliclazide), while another study observed the use of NovoNorm in combination with metformin. Studies have measured the level in the blood of a substance called glycosylated hemoglobin (HbA1c), which indicates the effectiveness of blood glucose control.
What benefit has NovoNorm shown during the studies?
In all the studies NovoNorm resulted in a decrease in the level of HbA1c, which indicates that the efficacy of the regulation of blood glucose levels was similar to that of the other comparator medicines. In the study involving the use of NovoNorm in combination with metformin, the effects of the two drugs proved to be at least additives (equivalent to the effects of the two medicines given together).
NovoNorm produced a good meal-induced insulin response within thirty minutes of being given to patients with type 2 diabetes, resulting in a reduction in blood glucose throughout the meal. The level of insulin (increased by the medicine) returned to normal after the meal.
What is the risk associated with NovoNorm?
The most common side effects seen with NovoNorm (seen between 1 and 10 patients in 100) are hypoglycemia (low blood glucose), abdominal pain and diarrhea. For the full list of all side effects reported with NovoNorm, see the Package Leaflet.
NovoNorm should not be used in people who may be hypersensitive (allergic) to repaglinide or other components of the medicine. It must not be used in patients with type 1 (insulin-dependent) diabetes who do not have any "peptide C" (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 also taking gemfibrozil (a medicine used to reduce blood fat levels). The dosage of NovoNorm may need to be adjusted if the drug is given along with some cardiopharmaceuticals, analgesics, asthma killers and medicines used for other conditions. The complete 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 marketing authorization.
More information on NovoNorm
On 17 August 1998, the European Commission granted NovoNorm a marketing authorization valid throughout the European Union to Novo Nordisk A / S. This authorization was renewed on 17 August 2003 and 17 August 2008.
For the full EPAR for NovoNorm, click here.
Last update of this summary: 07 - 2008
