Satisfaction of switching to combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes receiving multiple daily insulin injection therapy: A randomized controlled trial

Abstract

Aims/IntroductionWe compared the satisfaction levels of patients with type 2 diabetes undergoing combination therapy with lixisenatide (LIX) and basal insulin with that of patients undergoing multiple daily insulin injection (MDI) therapy.Materials and MethodsThe study was a 12‐week open‐label, randomized, multicenter, controlled trial. Participants were Japanese patients with type 2 diabetes receiving MDI for >3 months. Patients were randomly assigned to each treatment cohort: (i) a group that continued MDI (MDI group); and (ii) a group that switched from MDI to combination therapy with LIX and basal insulin (LIX group). The primary outcome was change in Diabetes Treatment Satisfaction Questionnaire scores from baseline to 12 weeks between these two groups. Key secondary outcomes were glycated hemoglobin and body weight changes.ResultsA total of 31 patients were initially enrolled in the study, and 26 of them completed the study. The change in Diabetes Treatment Satisfaction Questionnaire scores in the LIX group was significantly greater compared with that in the MDI group. Mean changes in glycated hemoglobin levels were −0.05 ± 0.37% in the MDI group and 0.04 ± 0.38% in the LIX group (P = 0.36). Mean changes in body weight were +0.6 ± 1.8 kg in the MDI group and −2.5 ± 1.8 kg in the LIX group (P < 0.01).ConclusionsSwitching from MDI to combination therapy with LIX and basal insulin improved satisfaction levels while maintaining glycemic control in Japanese patients with type 2 diabetes.

GLP‐1 receptor agonist added to insulin versus basal‐plus or basal‐bolus insulin therapy in type 2 diabetes: A systematic review and meta‐analysis

“…All 13 trials were open label; thus, there could have been a high risk of performance and detection bias; it is worth noting, however, that no other study design could have been used (ie, insulin needs to be titrated while most of GLP‐1RAs do not). For what concerns “incomplete outcome data,” all studies reported the discontinuation rate, ranging from 0% to 30%; in two studies, there was a statistically significant difference between arms . No selective reporting bias was found.…”

“…The first limitation relates to its scope: we did not extract data on BMI, waist and hip circumference, lipids, blood pressure, albuminuria, and adverse events other than hypoglycaemia; for this reason, we were not able to fully describe the benefits and limits of GLP-1RA added to insulin versus BP/BB insulin regimens. Data on daily insulin dose and hypoglycaemia were not always reported, [14][15][16][17]19,25 and this is a second limitation. Third, a high heterogeneity for all the evaluated outcomes was found, so caution should be taken in generalizing the results to clinical practice.…”

“…For what concerns "incomplete outcome data," all studies reported the discontinuation rate, ranging from 0% to 30%; in two studies, there was a statistically significant difference between arms. 18,19 No selective reporting bias was found. Finally, an industrial sponsor funded the study and was involved in data analysis in nine RCTs.…”

“…Of note, RCTs addressing the shift from BP/BB insulin therapy to GLP-1RA/insulin combinations are limited. Two studies enrolling patients on multiple daily insulin injections for at least 3 months were published by Miya et al and Yamamoto et al; the inclusion criteria and duration of follow-up limit the generalizability of the results across clinical settings 17,19. One RCT study addressing the same issue has recently been completed: 814 patients on BB insulin were randomized to albiglutide added to glargine or BB insulin.Approximately 50% of the patients in the albiglutide arm were able to replace prandial insulin without lispro reintroduction through week 26.…”

Satisfaction and efficacy of switching from daily dipeptidyl peptidase-4 inhibitors to weekly trelagliptin in patients with type 2 diabetes—Randomized controlled study—

“…We recently reported that a combined injection of basal insulin and glucagon-like peptide 1 receptor agonist improved DTSQ scores to a greater extent than multiple daily insulin injections in patients with type 2 diabetes [23]. From these reports, it appears that for injection therapies, lower injection frequency, lower HbA1c, and lower body weight were closely related to better treatment satisfaction among patients [23][24][25]. However, in this study, the participants did not receive an injected therapy, and switching from a daily to a weekly DPP-4 inhibitor did not alter HbA1c or body weight.…”