Rationalisation of previous multiple insulin treatment by switching to a fixed combination of basal insulin degludec and the GLP1-receptor agonist liraglutide (IDegLira): results of the SIMPLIFY study after 14 weeks
Emil Martinka 1; Rid Dravecká 2; Ivan Tkáč 3
Národný endokrinologický a diabetologický ústav, n. o., Ľubochňa
1; I. interná klinika LF UPJŠ a UNLP Košice
2; Excelentný tím pre výskum aterosklerózy (EXTASY), IV. interná klinika LF UPJŠ a UN LP Košice
Forum Diab 2022; 11(Supplementum): 6-14
Characteristics and aim of the study: A non-randomized, open-label, multicenter, single-arm prospective study in Real Word Evidence (RWE) with aim to evaluate whether switching from basal insulin + prandial insulin boluses (IIT) to fixed-combination of the basal insulin analogue degludec and the GLP-1 receptor agonist liraglutide (IDegLira) in patients with type 2 diabetes mellitus (DM2T) is at least as effective as previous IIT treatment in terms of glycemic control, body weight, blood pressure and blood fat levels. (Analysis of results after the first 14 weeks). Materials and methods: The study enrolled 147 patients with DM2T with duration > 5 years, on IIT treatment > 12 months, with HbA1c > 7 %, with preserved insulin secretion and total daily insulin dose (TDDI) < 0.7 IU/kg body weight resp. < 70 IU/day. Parameters of glycemic control (HbA1c, glycemia in glycemic profiles) were compared during the treatment of IIT and subsequently after 14 weeks of treatment after switching to IDegLira. In a subgroup (n = 31) patients, continuous glucose monitoring (CGM) was performed and parameters time in range (TIR) were evaluated. Other endpoints were body weight (BW), body mass index (BMI), blood pressure, lipids, hypoglycemia, and insulin doses were evaluated. Switch from IIT to IDegLira was performed in a single ambulatory session with an initial dose of IDegLira up to 16 DU (Dose Units) followed by a titration of ± 2–4 DU / 3 days. Results: Analysis of the results after the first 14 weeks of treatment showed that the switch from IIT to IDegLira was associated with a significant improvement both with HbA1c (8.6 ± 0.9 vs 7.7 ± 1.2, p < 0,0001) and plasma glucose levels in glycemic profiles. TIR (time in range) and TAR (time above range) values were also improved, but the difference was not statistically significant. Change of treatment has also been associated with significant reductions in BW (97.7 ± 18.3 vs 94.2 ± 17.9, p < 0,0001), BMI, systolic blood pressure, triglycerides, total cholesterol and LDL-cholesterol. There was also significant reductions in frequency of hypoglycemia both in selfmonitoring (0.52 vs 0.03 episodes per patient, 19,7 % vs 3,4 % proportion of patients) and TBR („time below range“) 2.8 % vs 0.8 %, p < 0,05 in CGM, and a significant decrease in insulin doses (55.6 ± 14.3 vs 30.9 ± 9.4, p < 0,0001). Conclusion: Switch from IIT to IDegLira in DM2T with HbA1c > 7 %, preserved insulin secretion and TDDI < 70 IU is safe, effective and less demanding form of treatment, the benefit of which manifests already after 14 weeks of treatment.
type 2 diabetes mellitus – CGM – IDegLira – intensified insulin treatment – simplification
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