Baseline HbA1c, BMI Do Not Affect Clinical Outcomes of Fast-Acting Insulin Aspart
Previous studies have shown that baseline characteristics related to disease severity can predict treatment outcomes of glucose-lowering therapies.
According to study results published in Diabetes Therapy, baseline glycated hemoglobin (HbA1c) and body mass index (BMI) do not significantly influence treatment differences between mealtime fast-acting insulin aspart and comparator therapies.
In this post hoc analysis of 3 randomized phase 3 trials, researchers sought to assess the association between baseline HbA1c and BMI and the efficacy and safety outcomes of basal insulin therapies with mealtime fast-acting insulin aspart, insulin aspart, and basal insulin alone. In total, 1686 participants with type 1 or type 2 diabetes were stratified according to baseline BMI or HbA1c and assessed for change in HbA1c, hypoglycemic episode rates, total daily insulin dose, and body weight change.
In the first trial, most participants had baseline HbA1c levels of ≤7.5% and a baseline BMI of 25 to <30 kg/m2, while in the second and third trials the majority of participants had HbA1c levels of ≥8% and a baseline BMI of ≥30 kg/m2. The first and second trials compared fast-acting insulin aspart with insulin aspart as part of a basal-bolus regimen, and the third compared fast-acting insulin aspart with basal insulin with basal insulin-only therapy.
Compared with the alternatives, fast-acting insulin aspart had similar or superior HbA1c reduction in most subgroups. In the first and second trials, there were no significant differences between treatment groups with regard to hyperglycemic episodes. However, in the third trial, the rate of hypoglycemic episodes was significantly higher in patients treated with fast-acting insulin aspart than patients in the basal insulin-only therapy group.
The researchers discovered no significant difference between groups in trials 1 and 2 regarding mean daily total insulin dose, but the group receiving fast-acting insulin aspart did experience a lower mean daily total insulin dose in the third trial. In a similar fashion, there were no significant between-group differences in mean body weight change in trials 1 and 2, but in the third trial, the group receiving fast-acting insulin aspart did experience a significantly greater increase in body weight from baseline due to the more intensive therapy.
Several limitations were noted for this study, including potential misclassification of subgroups due to possible diagnostic error stemming from lack of biologic measures.
Based on their results, the researchers said that although a patient's baseline BMI and HbA1c may not have an impact on treatment response from faster insulin aspart to any clinically relevant degree, “in clinical practice, these baseline characteristics, in the context of a wider patient profile including social and psychological factors, may be used by clinicians to guide clinical decision-making within a [patient-centered] model of diabetes management.”
Multiple authors declared associations with the pharmaceutical industry. Please see the original reference for a full list of authors' disclosures.
Bowering K, Rodbard HW, Russell-Jones D, et al. Investigating the association between baseline characteristics (HbA1c and body mass index) and clinical outcomes of fast-acting insulin aspart in people with diabetes: a post hoc analysis [published online December 13, 2018]. Diabetes Ther. doi:10.1007/s13300-018-0553-7