Insulin Analogues Hardly Tested

Photo: Person checking blood with a needle next to the hand

Studies of longer duration are
needed to be sure about the effect
of insulin analogues; © SXC

Due to a lack of suitable studies, it remains unclear whether children and adolescents with type 1 diabetes benefit more or less from long-term treatment with rapid-acting insulin analogues than with short-acting human insulin. Certainly, there is no proof of additional benefit from the available results from clinical trials of maximum one year duration. This applies both in the comparison with human insulin and in the comparison between analogues only. This is the conclusion of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG).

The Institute believes that studies of longer duration are urgently needed because insulin performs a variety of functions particularly during stages of human growth and development and it is not clear what effect insulin analogues have.

IQWiG could only identify four suitable studies that conducted comparisons among human insulin and insulin analogues in children and adolescents with type 1 diabetes. All four studies investigated the use of analogue insulin in intensified injection therapy. No relevant study was found on pump therapy, which is in common use. In the studies, the young patients were investigated for 24 to 26 weeks, in one case for twelve months.

IQWiG found no proof of additional benefit of analogues in these studies. This applied to the comparison with human insulin as well as to comparisons between analogues only. The majority of data available concerned long-term glucose control in the form of the HbA1c value and the frequency of hypoglycaemia. If the results of these two aspects are analysed, no advantage is shown for any of the analogue insulins in any of the studies.

As suitable studies of several years' duration are lacking, scarcely any conclusions can be drawn concerning the potential harm of rapid-acting insulin analogues. However, in some of the studies, a serious metabolic crisis (ketoacidotic coma) occurred more frequently in patients who injected insulin analogues. Nevertheless, the differences were not statistically significant. Due to the short observation period and the paucity of results, it cannot be confirmed whether the use of short-acting insulin analogues increases the risk of ketoacidosis.; Source: Institute for Quality and Efficiency in Health Care