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Review
. 2023 Nov 27:14:1301931.
doi: 10.3389/fphar.2023.1301931. eCollection 2023.

The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia

Sofie Broeng-Mikkelgaard  1 , Julie Maria Bøggild Brøsen  1 , Peter Lommer Kristensen  1   2 , Birger Thorsteinsson  1 , Ulrik Pedersen-Bjergaard  1   2
Affiliations
Review

The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia

Sofie Broeng-Mikkelgaard et al. Front Pharmacol. .

Abstract

Type 1 diabetes is characterized by insulin deficiency, and treatment is to supply insulin mimicking the physiological endogenous insulin secretion. Since its discovery, insulin therapy has evolved, and since the 1990s, an increasing number of insulin analogs with various pharmacokinetic and pharmacodynamic profiles have become available. Despite the improvement of insulin therapy, hypoglycemia remains the main side effect and is a daily concern for many people with diabetes and their families. A proportion of people with type 1 diabetes are at increased risk of hypoglycemia and experience recurring episodes. When designing insulin trials, this group of people is most often excluded in order to reduce the risk of adverse study outcomes, even though it may be the group that may benefit the most from treatment with new insulins. The results of the phase III trials, therefore, underestimate the clinical impact and pharmacoeconomic effect of the implementation of new insulins in the broader type 1 diabetes population. This paper reviews the four insulin trials that include people at increased risk of hypoglycemia. In general, the studies confirm the results from phase III trials in terms of similar reduction and maintenance of HbA1c, as well as relative rate reductions of hypoglycemia. However, the absolute treatment differences in the reduction of hypoglycemia are even greater in the trials, including people at high risk of hypoglycemia. This emphasizes the importance of including people at high risk of hypoglycemia to assess the full clinical and pharmacoeconomic benefit of new insulins.

Keywords: hypoglycemia; insulin analogs; insulin degludec; insulin detemir; insulin glargine; insulin lispro; randomized clinical trials; type 1 diabetes.

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Conflict of interest statement

PLK has received speakers fee from Sanofi-Aventis A/S, Boeringer Ingelheim A/S, Novo Nordisk A/S, and AstraZeneca A/S. UPB has served on advisory boards for Sanofi-Aventis A/S, Novo Nordisk A/S and Vertex A/S, and has received lecture fees from Abbott A/S, Sanofi-Aventis A/S and Novo Nordisk A/S. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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