IDF21-0679 INTENSIFY: effectiveness of insulin degludec/liraglutide (IDegLira) in a real-world T2DM population in the UAE

Abstract

Background: In patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, combining a glucagon-like peptide-1 receptor agonist (GLP-1 RA) with basal insulin (BI) offers an effective treatment-intensification strategy. A fixed-ratio combination of insulin degludec and liraglutide (IDegLira; Novo Nordisk) was launched in the United Arab Emirates (UAE) in 2018. Aim: To investigate the effect of IDegLira in a real-world population of patients with T2DM switching from BI or GLP-1 RA (± oral antidiabetic drugs [OADs]) in routine clinical practice in the UAE. Method: INTENSIFY was a 26–38-week, multicentre, prospective, non-interventional, real-world study. T2DM patients (≥18 years) with inadequate glycaemic control on BI or GLP-1 RA (± OADs) were eligible if a switch to IDegLira had been planned. The primary endpoint was change in laboratory measured HbA1c from baseline to end of the study. Secondary endpoints included overall change in fasting plasma glucose (FPG); change in body weight; incidence of hypoglycaemic episodes in the 4-week (non-severe and nocturnal non-severe episodes) and 26-week (severe episodes) periods before end of study (EOS) versus before initiation of IDegLira treatment. Treatment preference and safety were also assessed. ClinicalTrials.gov identifier: NCT03823339 Results: Among 263 patients, 206 (78.3%) and 57 (21.7%) patients had previously received BI ± OADs and GLP-1 RA ± OADs, respectively. Baseline mean HbA1c was 9.29%. Switching to IDegLira was associated with a significant overall reduction in HbA1c, with an estimated mean (SE) change from baseline of –0.9% (0.1%), 95% CI, –1.1 to –0.7 (p<0.0001). There was also a significant reduction in FPG: overall mean (SE) change from baseline was –48.2 (5.9) mg/dL, 95% CI, –59.9 to –36.5 (p<0.0001). A significant reduction in body weight was achieved among patients previously treated with BI ± OADs,with an estimated mean (SE) change from baseline of –1.1 (0.2) kg, 95% CI, –1.5 to –0.6 (p<0.0001). The estimated incidence of hypoglycaemic episodes was numerically lower in the periods before EOS versus before initiation of IDegLira treatment (2 vs. 13, 2 vs. 6, and 2 vs. 4 episodes for non-severe, nocturnal non-severe, and severe hypoglycaemia, respectively). Overall, the number of IDegLira dose steps increased significantly (mean [SE] change, 6.1 [0.6] steps, 95% CI, 5.0–7.2 [p<0.0001]). Most patients (86%) preferred IDegLira over previous treatments. IDegLira was well tolerated with no unexpected safety findings. Discussion: Switching from BI or GLP-1 RA (± OADs) to IDegLira significantly improved glycaemic control in adults with T2DM. There were significant overall reductions in HbA1c and FPG; a significant reduction in body weight among patients previously on BI ± OADs, and a reduction in hypoglycaemic events. Conservative dose titration (an increase of approximately 1 dose step per month) was identified in the INTENSIFY study. A stricter titration schedule and frequent interaction between patients and investigators may have led to greater improvement in both primary and secondary endpoints.