medwireNews: Findings from the DUAL IX trial suggest that the addition of insulin degludec/liraglutide (IDegLira) to sodium-glucose cotransporter (SGLT)2 inhibitor therapy results in better glycemic control than add-on insulin glargine among insulin-naïve patients with uncontrolled type 2 diabetes.
“In clinical practice, therapy intensification for this group of patients would typically be basal insulin initiation; however, our results indicate that addition of IDegLira is a superior treatment option,” say Athena Philis-Tsimikas (Scripps Whittier Diabetes Institute, San Diego, California, USA) and co-investigators.
The open-label phase IIIb trial included 419 patients with an average diabetes duration of 9.3–9.8 years and baseline glycated hemoglobin (HbA1c) levels of 7.0–11.0% (average 8.2–8.4%) despite treatment with SGLT2 inhibitors alone or in combination with up to three other oral antidiabetic agents (metformin, dipeptidyl peptidase-4 inhibitors, and/or pioglitazone). The most commonly used SGLT2 inhibitor was dapagliflozin (44.5%), followed by empagliflozin (34.8%), and canagliflozin (20.5%).
As reported in Diabetes, Obesity and Metabolism, the 209 patients who were randomly assigned to receive once daily add-on IDegLira – a fixed-ratio combination of the basal insulin degludec and the glucagon-like peptide-1 receptor agonist liraglutide – experienced an average reduction in HbA1c levels of 1.9 percentage points.
This was significantly greater than the average reduction of 1.7 percentage points for the 210 patients given add-on insulin glargine 100 units/mL.
Participants in the IDegLira group also experienced significantly lower rates of hypoglycemia (12.9 vs 19.5%) over the study period, and had a significantly lower total daily insulin dose at week 26 (mean, 36.2 vs 53.5 units) than those given insulin glargine. There was no change in average bodyweight from baseline to week 26 among patients given IDegLira, whereas those in the insulin glargine group had a mean increase of 2.0 kg.
The study authors emphasize that a significantly higher proportion of patients treated with IDegLira versus insulin glargine achieved the “clinically-relevant composite endpoint” of HbA1c levels below 7% without weight gain or hypoglycemia, at 42% versus 17%, which they say highlights “the additional benefits beyond glycaemic control associated with IDegLira.”
Treatment-emergent adverse events were reported in a numerically greater proportion of patients treated with IDegLira compared with insulin glargine over the course of the study (61.7 vs 58.6%), which the investigators attribute mainly to higher rates of increased lipase levels (5.7 vs 1.4%) and nausea (5.7 vs 0.5%) in the IDegLira group.
Overall, “[t]he majority of AEs were nonserious, mild in severity, and unlikely to be related to trial products as judged by the investigator,” they say.
The team concludes that the DUAL IX results are “[c]onsistent with previous reports from the DUAL programme,” and confirm that “the effects of IDegLira are preserved in patients already on a SGLT2 inhibitor treatment regimen.”
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