Faster insulin aspart shows real-world efficacy for T1D
For patients with type 1 diabetes (T1D), switching to faster insulin aspart may improve glycated haemoglobin (HbA1c), time-in-range (TIR), and time in hyperglycaemia, without posing serious hypoglycaemia risks, according to a new study.
“Most of the clinical data on faster aspart are from the controlled ‘onset’ treat-to-target clinical trials; there is limited real-world evidence of the impact of faster aspart,” the researchers said. The present study thus sought to remedy that, using intermittent-scanning continuous glucose monitoring (iscCGM) to illustrate the impact of the intervention.
In total, 243 T1D patients (mean age, 49.9±16.6 years; 55.6 percent male) were enrolled in the full analysis set, from which subsets were drawn for efficacy analysis and safety analysis, with or without available iscCGM data.
Patients who were on faster aspart saw a drop in HbA1c, from 8.1 percent at baseline to 7.9 percent after 24 weeks of medication. The resulting difference value was statistically significant (–0.19 percent, 95 percent confidence interval [CI], –0.27 to –0.10; p<0.0001). The 12-week change in HbA1c also represented a significant drop from baseline (–0.15 percent, 95 percent CI, –0.24 to –0.07; p=0.001). [Diabetes Technol Ther 2020;doi:10.1089/dia.2020.0360]
For the efficacy analysis, 92 patients had available data from the iscCGM devices. These patients showed a significant 24-week drop in postprandial glucose (–0.8±2.4 mmol/L; p=0.002), fasting preprandial glucose (–0.8±2.4 mmol/L; p=0.005), and estimated HbA1c (–0.2±0.8 percent; p=0.035).
Moreover, the devices recorded a significant increase in the average minutes per day spent in the target range by 46.1 minutes (p=0.009). This was accompanied by a drop in the time spent in hyperglycaemia, as defined by a >10 mmol/L threshold, by 43.5 minutes (p=0.024). When the threshold for hyperglycaemia was raised to >13.9 mmol/L, the change in the time spent decreased slightly but remained significant (–35.6 minutes; p=0.015).
In comparison, the time spent in hypoglycaemia was virtually unchanged as compared with baseline values. The same was true for the number of episodes of hypoglycaemia or of very low glucose.
In terms of safety, the researchers reported six serious adverse reactions (SARs), five of which were nonfatal and occurred in four patients; one SAR episode was fatal and happened after a patient engaged in physical activities and experienced very low blood sugar. All nonfatal SARs were hospitalizations due to ketoacidosis.
“The key strength of the study was the enrolment of patients in a real-world setting, where the decision to initiate faster aspart was made independently of study participation,” the researchers said. “Accordingly, the reported outcomes provide important insights into the impact of iscCGM and faster aspart on patients in the clinic and they merit further study on a global level.”
“Overall, our findings support the treatment switch to faster aspart in combination with iscCGM in insulin-experienced patients with T1D, particularly in those in need of better glycaemic control and/or more flexible bolus administration,” they added.