insulin glargine (Lantus Solostar)

Following an abbreviated submission

insulin glargine 100 units/ml solution for injection in a pre-filled pen (Lantus SoloStar) is accepted for restricted use in the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required.

It may be used in patients in whom treatment with this insulin analogue is appropriate and in whom the use of a pre-filled pen offers advantages over a pen and cartridge device.

The use of insulin glargine should be targeted on patients with Type I diabetes who are at risk of or experience unacceptable frequency and/or severity of nocturnal hypoglycaemia on attempting to achieve better hypoglycaemic control during treatment with established insulins. It is also acceptable as a once daily insulin therapy for patients who require carer administration of their insulin.

In patients with type 2 diabetes it should be restricted to those who suffer from recurrent episodes of hypoglycemia or require assistance with their insulin injections.