Glycemic Control Among Patients Newly Prescribed IDegLira Across Prior Therapy Group in US Real-World Practice

Abstract

Introduction: IDegLira is a fixed-ratio combination of insulin degludec and liraglutide indicated for the treatment of type 2 diabetes (T2D). We report the first real-world study describing change in glycated hemoglobin (HbA1c) among US patients who initiated IDegLira. The aim of the study was to observe and describe changes in glycemic control and weight in patients initiating IDegLira in real-world clinical practice. Methods: Patients in the Practice Fusion electronic medical record database who initiated treatment with IDegLira between March 2017 and June 2018 were identified (n = 1384). To be included in the analyses, the study population needed to meet age, time in database pre-and post-initiation, and availability of HbA1c data at baseline and follow-up requirements. Data were analyzed according to baseline therapy subgroups and whether patients were intensifying (primary analysis group) or simplifying (secondary analysis group) their diabetes treatment. Changes in clinical outcomes from baseline were evaluated by paired t tests and linear regression. Results: The overall study population comprised 296 patients, of whom 206 were included in the primary analysis group and 90 were included in the secondary analysis group. In the adjusted analyses, there was a reduction in HbA1c of-1.1% in the primary analysis group, with the HbA1c reduction in all prior therapy groups ranging from-0.8% for those previously on basal insulin to-1.0% for those previously on non-injectable therapy (p \ 0.0001 for all). In a similar adjusted analysis, there was a statistically significant but small (1.0 lb/0.45 kg) change in weight in the primary analysis group. In the secondary analysis, patients previously on more than one injection daily switched to a more simplified therapy without compromising on glycemic control (HbA1c change of-0.16%). Conclusion: Consistent with previous realworld studies, IDegLira lowered HbA1c across different background prior glucose-lowering therapies, with minimal impact on weight.

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

“…IDegLira was approved in the European Union (EU) in September 2014 and in Italy in September 2017, with a recent label update allowing patients on any insulin regimen with a basal component, including the basal-bolus regimen, to switch to IDegLira. Several real-world evidence (RWE) studies have evaluated the effectiveness of IDegLira both as an intensification regimen in patients inadequately controlled by basal-supported oral therapy (BOT) and as a de-intensification regimen in patients on basal plus bolus insulin (BB) [ 14 – 16 ]. Real-world retrospective results from the European, multicenter EXTRA study suggest that patients switching from a BB regimen not only have the expected beneficial reductions in HbA1c and body weight after 6 months of treatment but also reduce their total daily insulin dose while avoiding the inconvenience of multiple dose injections [ 17 ].…”

Short-Term Effectiveness and Reduction in Insulin Requirements in Patients With Type 2 Diabetes Treated With IdegLira in a Real-World Setting

“…The proven effectiveness in clinical trials of the IDegLira development program ( 8 , 9 , 14 – 19 ) has also been reported in real-life scenarios with reductions in HbA1c in the range of 0.3% to 2.2% ( 20 ) [preserving the tendency of the Bloomgarden effect ( 21 )]: the higher the basal level the greater the control effect on HbA1c. The finding of a reduction close to one percentage point in HbA1c in people whose initial median was 8.5% is interesting given the time of disease progression in this group of patients as well as the high proportion of those treated with insulin and the low dose of insulin degludec/liraglutide reported at the end of follow-up.…”

Transitioning from basal–bolus or premix insulin therapy to a combination of basal insulin and glucagon‐like peptide‐1 receptor agonist in people with type 2 diabetes

“…The search terms are presented in Table S1. The search results were discussed by the author group and relevant articles were identified; 19–33 these are summarised in Tables 1 and 2 19–33 …”

“…The search terms are presented in Table S1. The search results were discussed by the author group and relevant articles were identified; [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] these are summarised in Tables 1 and 2. [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]…”

“…Six months after transitioning to IDegLira from MDIs, there was a reduction in mean adjusted HbA1c of −0.3 mmol/mol (−0.03%) and a reduction in mean adjusted body weight of −2.2 kg. 22 Hypoglycaemia and TDD were not reported.…”