Simplification of previous multiple insulin treatment by switching to a fixed combination of basal insulin degludec and GLP1-receptor agonist liraglutide: SIMPLIFY study Evaluation of the early outcome questionnaires

Overview

Intoduction: Despite the wide range and availability of antidiabetic therapy for the management of type 2 diabetes mellitus (T2D), less than 50% of patients still achieve optimal metabolic control. Among the causes, physician and patient iner­tia, lack of patient adherence to treatment for several reasons but also (lack of) education about the need for treatment modification or patient motivation to persist on the changed treatment play an important role. Aim of the study. IIT (Intensive Insulin Therapy) to treatment with a fixed combination of the basal insulin analogue degludec and the GLP1-receptor agonist liraglutide (IDegLira) in patients with T2D is at least as effective in terms of metabolic control (glycaemia, blood lipids) of body weight and blood pressure as previous insulin treatment. We evaluated patients’ adherence and satisfaction with initial insulin treatment and after switching to IDegLira using questionnaires. Subjects and Methods: 230 patients were included in the study who met the inclusion criteria: informed consent, age 18–80 years, T2D duration of at least 60 months, were treated with basal-bolus insulin (for at least 12 months) and had unsatisfactory glycemic control (HbA_1c ≥ 7.0% DCCT). Patients completed two paper questionnaires (Questionnaire A, WHOQoL A) at the start of the study and after 3 months (Questionnaire B, WHOQoL B). As of 3/14/2022, the first 128 patient questionnaires had been asses­sed on an ongoing basis. Patients missing more than 20% of the completed data or not having completed all 4 questionnaires were excluded from the data. The study and evaluation of the questionnaires is further continued up to a duration of 6 months. Results: On the original basal-bolus regimen, diabetes or its treatment prevented 54% and 61% of patients from performing daily and leisure-time activities, respectively. After 3 months of treatment, significantly fewer respondents reported that diabetes/its treatment prevented them from performing daily (23%) and leisure-time activities (24%), respectively. 12% and 69% of respondents were very satisfied with IIT and IDegLira treatment, respectively. Concerns regarding treatment were expressed by 38% on IIT and 11% on IDegLira. On the basal-bolus regimen, most patients (53%) were concerned about weight gain and hypoglycemia (45%), while up to 56% had no concerns after the change in treatment. IDegLira treatment was rated by 91% as significantly easier, with its greatest advantages being once-daily application (98%), weight loss (58%), and fewer hypoglycemic episodes (40%). Overall, 50% of patients rated physician information about basal-bolus therapy as very easy, compared with 77% for IDegLira. Dose adjustment in the home setting was managed by 34% for IIT, and after 3 months of IDegLira therapy, patients found titration completely easy in 70%. Insulin was forgotten at least 1 time a day by 32% of patients on IIT, and IDegLira was forgotten by 4% of patients. Satisfaction with IIT was expressed by 42% of respondents and 77% with IDegLira. This compared to 65% of patients on the IIT regimen who rated their quality of life as good/very good, compared to 79% of patients treated with IDegLira. The difference in perception of negative feelings was not significant. Life was very much enjoyed by 30% on IIT and 45% on IDegLira. With IDegLira, more patients reported life as meaningful, with better ability to concentrate and a greater sense of security during ordinary life. After the treatment change, more IDegLira-treated patients reported having enough energy for daily life and more opportunities to engage in leisure activities. Availability of information for daily life was comparable for both regimens. Summary: Compared to the basal-bolus regimen, 3 months after switching to IDegLira, patients were more satisfied with the treatment and were able to engage in more daily and leisure time activities. The treatment was much easier for them, the biggest benefit was the once a day application, less weight gain and less hypoglycemia. Their overall quality of life improved significantly with the new treatment.

Keywords:

Quality of life – Inertia – type 2 diabetes mellitus – adherence – intensified insulin therapy – metabolic compensation – satisfaction – SIMPLIFY study