A Real-World, Prospective, Non-interventional Study of Adults with T2D Switching to IDegAsp from Glargine U100 or U300 in Japan

Abstract

Introduction: This real-world study investigated glycaemic control and quality of life (QoL) in insulin-experienced Japanese patients with type 2 diabetes (T2D) who switched to insulin degludec/insulin aspart (IDegAsp).

Methods: This was a prospective, non-interventional, open-label, single-arm study. Eligible patients were adults (aged ≥ 20 years) with T2D, previously treated with insulin glargine 100 or 300 units/mL (glargine U100/U300) with or without prandial insulin, who switched to IDegAsp as part of routine practice. Change from baseline to end of study (EOS; 26 weeks after initiation or IDegAsp discontinuation) in the following endpoints was assessed by adjusted mixed models for repeated measures: glycated haemoglobin (HbA1c; primary endpoint), fasting plasma glucose (FPG), insulin dose and total Diabetes Therapy-Related Quality of Life (DTR-QoL) score. Non-severe hypoglycaemia was assessed in the 4-week period prior to initiating IDegAsp and in the 4-week period before EOS or discontinuation using negative binomial regression.

Results: The full analysis set included 236 patients from 29 centres in Japan with mean (± SD) age 63.2 years (± 12.3), HbA1c 7.7% (± 1.0) and diabetes duration 14.9 (± 9.3) years. After 26 weeks with IDegAsp, HbA1c (estimated change - 0.1% [- 0.2; 0.0]95% confidence interval (CI), p = 0.3036) and FPG (- 7.5 mg/dL [- 23.5; 8.5]95% CI, p = 0.3477) were maintained; there were significant reductions in basal and total insulin dose: estimated change of - 3.4 units/day [- 3.8; - 3.0]95% CI and - 1.0 units/day [- 1.9; - 0.1]95% CI, respectively (both p < 0.05). Non-severe hypoglycaemia rates were similar in the periods before and after initiating IDegAsp, while there was a significant improvement in total DTR-QoL score after 26 weeks with IDegAsp (p = 0.0012).

Conclusion: These real-world data suggest that switching to IDegAsp from glargine U100 or U300 was well tolerated in a Japanese population with T2D, with no new safety or tolerability signals, and associated with maintenance of glycaemic control and improved QoL.

Trial registration: This study is registered at ClinicalTrials.gov: NCT03745157.

Keywords: Insulin degludec/insulin aspart; Japanese population; Quality of life, real-world evidence; Type 2 diabetes.

© 2021. The Author(s).

Figures

Fig. 1

Change in mean HbA1c from baseline to 26 weeks after insulin degludec/insulin aspart (IDegAsp) initiation. Full analysis set, on-treatment observation period. Data are observed means (± standard deviation [SD]). Estimated mean change (from baseline to end of study) was derived by an adjusted mixed model for repeated measurements (MMRM) with an unstructured covariance matrix, time and time squared as fixed effects, and patient and patient × time as random coefficients. The model included baseline HbA1c, time, age, sex, diabetes duration, body mass index (BMI), baseline prandial insulin, baseline glucagon-like peptide-1 receptor agonist (GLP-1 RA) and study site as covariates. CI Confidence interval, HbA1c glycated haemoglobin, n number of patients contributing data to time point

Fig. 2

Change in mean FPG from baseline to 26 weeks after IDegAsp initiation. Full analysis set, on-treatment observation period. Analysed by a crude and an adjusted MMRM with an unstructured covariance matrix, time and time squared as fixed effects, and patient and patient × time as random coefficients. The model included baseline FPG, time, age, sex, diabetes duration, BMI, baseline prandial insulin, baseline GLP-1 RA, baseline sulphonylurea/glinides and study site as covariates. FPG Fasting plasma glucose; see Fig. 1 caption for other abbreviations

Fig. 3

Change in mean insulin dose from baseline to 26 weeks after IDegAsp initiation. Full analysis set, on-treatment observation period. Data are observed means (± SD). Estimated mean change (from baseline to end of study) was derived using adjusted MMRMs with an unstructured covariance matrix, time and time squared as fixed effects, and patient and patient × time as random coefficients. The models included baseline insulin dose, time, age, sex, diabetes duration, BMI, baseline prandial insulin, baseline GLP-1 RA, baseline sulphonylurea/glinides and study site as covariates. Superscript ‘a’ indicates that insufficient data were available for statistical analysis. N/A Not applicable; see Fig. 1 caption for other abbreviations

Fig. 4

Median Diabetes Therapy-Related Quality of Life (DTR-QoL) scores at baseline and 26 weeks after IDegAsp initiation. Data are observed median scores. n Number of patients contributing data to time point