Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.


Apidra SoloStar (sanofi-aventis)
100 IU/mL in 3 mL cartridges for use in reusable insulin injection device
Approved indication: diabetes mellitus
Australian Medicines Handbook section 10.1.1

Insulin analogues are genetically engineered to try and improve the control of blood glucose in patients with diabetes.1 Insulin glulisine differs from human insulin by only two amino acids. This difference results in a more rapid and short-acting effect on blood glucose.

Patients can inject insulin glulisine in the 15 minutes before, or immediately after, a meal. The analogue reaches a higher maximum concentration faster than a subcutaneous injection of regular human insulin (55 vs 82 minutes) in type 1 diabetes. In type 2 diabetes, the median time to maximum concentration is 89 minutes with insulin glulisine and 94 minutes with insulin. Insulin glulisine is also eliminated more rapidly with a half-life of 42 minutes compared with 86 minutes for regular insulin. Although the maximum concentration of insulin glulisine is approximately twice that of regular insulin, one unit of insulin glulisine has the same glucose-lowering effect as one unit of regular insulin.

Insulin glulisine needs to be used with a longer-acting insulin to provide the patient's basal requirements. It should not be mixed with other insulins (except NPH insulins) before injection.

A comparative study, in patients with type 1 diabetes using insulin glargine for their basal requirements, found that the efficacy of insulin glulisine was similar to that of insulin lispro (another quickly absorbed analogue). In patients with type 2 diabetes using NPH insulin, injecting insulin glulisine 15 minutes or less before meals had a similar effect on glycaemic control to injecting regular insulin 30-45 minutes before meals.

Insulin glulisine has the same adverse reactions as other insulin preparations, but long-term experience is more limited. It has not been approved for use in children less than 12 years, but the reasons are not clear.

manufacturer provided only the product information

The Transparency Score () is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.

Notes on references

At the time the comment was prepared, information about this drug was available on the web site of the Food and Drug Administration in the USA (www.fda.gov).

At the time the comment was prepared, a scientific discussion about this drug was available on the website of the European Medicines Agency (www.emea.europa.eu).

References

  1. Phillips P. Insulins in 2002. Aust Prescr 2002;25:29-31.