DUAL IX trial confirms efficacy, safety of insulin degludec/liraglutide + SGLT2i combo for T2D
Adding insulin degludec/liraglutide to SGLT2i* may improve glycaemic control in patients with uncontrolled type 2 diabetes (T2D), according to the DUAL IX** trial presented at EASD 2018.
The open-label, noninferiority, treat-to-target trial evaluated 420 insulin-naïve patients with T2D who were randomized in a 1:1 ratio to receive either insulin degludec/liraglutide (IDegLira) or glargine 100 units/mL (IGlar U100) in addition to SGLT2i for a 26-week treatment period. [EASD 2018, abstract OP79]
At 26 weeks, patients treated with IDegLira had a significant reduction in HbA1c levels from baseline compared with IGlar U100 (change from baseline, -1.94 percent vs -1.68 percent, estimated treatment difference [ETD], -0.36 percent; p<0.0001).
More patients on IDegLira achieved the target HbA1c level (<7.0 percent) than those on IGlar U100 (84.8 percent vs 71.3 percent, odds ratio [OR], 1.98). Among the patients who had achieved the target HbA1c levels, more patients treated with IDegLira did so without having hypoglycaemia events (79.2 percent vs 56.4 percent, OR, 2.76) and weight gain (46.2 percent vs 18.8 percent, OR, 3.53) compared with those in the IGlar U100 group.
At the end of the study, a significantly lower total daily insulin dose was required by patients who received IDegLira compared with IGlar U100 (36 vs 54 units, ETD, -15.37 units; p<0.0001). Among the patients who were at a maximum dose of 50 units, 83 percent had achieved the target HbA1c level.
An overall weight gain of 2.0 kg occurred in the IGlar U100 group, but none was reported in the IDegLira group. “As we have seen before, liraglutide helps to moderate the effect of weight gain that you might get with insulin,” said study lead author Dr Athena Philis-Tsimikas from UC San Diego Health-Jacobs Medical Center in San Diego, California, US.
Rates of treatment-emergent adverse events were comparable between the IDegLira and IGlar U100 groups (61.7 percent vs 58.6 percent), with a slight increase in lipase and nausea with the IDegLira treatment group, “but nothing overarching differences,” said Philis-Tsimikas.
“The DUAL IX study demonstrates the efficacy and safety of IDegLira treatment as an add-on to SGLT2i in patients with T2D uncontrolled on SGLT2i,” Philis-Tsimikas said.
“[Furthermore,] the results of DUAL IX indicate that IDegLira may be a better treatment option than IGlar U100 in patients on SGLT2i in need of intensification,” she added.
*SGLT2i: Sodium-glucose cotransporter-2 inhibitor
**DUAL IX: A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDeglira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus