How has it been studied?
NovoNorm has been studied in 45 ‘clinical pharmacology’ studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type 2 diabetes patients). A total of 2,156 patients received NovoNorm in all trials combined.

The main studies compared NovoNorm with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide). Another study looked at the effect of adding NovoNorm to metformin. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.

What benefits has it shown during the studies?
In all studies, NovoNorm led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines. In the study where NovoNorm was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
NovoNorm produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal. The raised insulin levels returned to normal after the meal.

What is the risk associated?
The most common side effects with NovoNorm (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea. 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 any of the other ingredients. It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘C-peptide’ in their blood (a marker of type 1 diabetes). It should also 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). NovoNorm doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions. The full list of these medicines is available in the Package Leaflet.

Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoNorm’s benefits are greater than its risks for the treatment of type 2 diabetes. The Committee recommended that NovoNorm be given marketing authorisation.

Further information
The European Commission granted a marketing authorisation valid throughout the European Union for NovoNorm to Novo Nordisk A/S on 17 August 1998. The marketing authorisation was renewed on 17 August 2003 and on 17 August 2008.

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Name

NovoNorm 2 mg tablets

Composition

Each tablet contains 2 mg of repaglinide.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Tablet

Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).

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