Lantus licence extended to include children 2 years and older

Lantus (insulin glargine) has been licensed for use in children aged two years and above with diabetes mellitus.

A clinical study found no evidence of accumulation of insulin glargine (a long-acting analogue of human insulin, pictured) or its metabolites following chronic dosing in children aged 2 to 6 years
A clinical study found no evidence of accumulation of insulin glargine (a long-acting analogue of human insulin, pictured) or its metabolites following chronic dosing in children aged 2 to 6 years

The dosage schedule for the long-acting insulin analogue is the same as for adults and children aged 6 years and over: one subcutaneous injection at the same time each day with the number of units determined by individual patient requirements.

Clinical study

A 24-week parallel-group study recruited 125 children aged 2—6 years with type 1 diabetes mellitus. Children were administered either insulin glargine once daily in the morning or NPH insulin once or twice daily. In addition, both groups received bolus insulin before meals.

Plasma trough concentrations of insulin glargine were similar to those normally seen in adults, and HbA1c and glucose variabilities were comparable in the two treatment groups. However, non-inferiority of insulin glargine to NPH in terms of hypoglycaemic events was not demonstrated and researchers noted a trend towards an increase in hypoglycaemic events with insulin glargine.

View Lantus drug record

Further information: Sanofi

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