Dataset Information

Long-Term Safety and Clinical Outcomes with Insulin Degludec/Insulin Aspart Treatment in Japanese Patients with Diabetes: A Real-World, Prospective, Observational Study.

ABSTRACT:

Introduction

Insulin degludec/insulin aspart (IDegAsp) provides effective glycaemic control with an acceptable safety profile in Japanese patients with diabetes in randomised clinical trials. This post-marketing surveillance study assessed long-term safety and clinical outcomes with IDegAsp in a Japanese real-world setting.

Methods

Multicentre, prospective, observational, open-label, single-arm study of Japanese patients with diabetes requiring insulin therapy, who had switched to IDegAsp at their treating physician's discretion in clinical practice. One year after initiating IDegAsp, incidence of adverse events (AEs [primary endpoint]), serious AEs, adverse drug reactions (ADRs), and severe hypoglycaemia (secondary safety endpoints) were assessed in the safety analysis set (SAS). Secondary effectiveness endpoints were change from baseline in glycated haemoglobin (HbA_1c) and fasting plasma glucose (FPG) in the effectiveness analysis set (EAS).

Results

Overall, 1321 patients were included (SAS, n = 1321; EAS, n = 1285); 4.2% with type 1 diabetes, 95.2% with type 2 diabetes, 0.7% with other/unknown diabetes type. In total, 204 AEs were reported in 132 patients (10.0% of the SAS), at a rate [95% confidence interval (CI)] of 16.2 events/100 patient-years of exposure (PYE) [14.0; 18.4]. By preferred term, 'hypoglycaemia' was the most frequent AE (45 events in 31 patients [2.3%]; rate [95% CI] 3.6 events/100 PYE [2.5; 4.6]). Serious AEs occurred in 4.2% of patients (rate [95% CI] 5.7 events/100 PYE [4.4; 7.0]), and ADRs in 3.1% (rate [95% CI] 4.6 reactions/100 PYE [3.4; 5.8]). Six events of severe hypoglycaemia were reported in five patients (0.4%; rate [95% CI] 0.5 events/100 PYE [0.1; 0.9]). Change from baseline to 1 year was - 0.51% and - 32.1 mg/dL for HbA_1c and FPG, respectively (P < 0.0001 for both).

Conclusion

In Japanese patients with diabetes, initiation of IDegAsp in real-world clinical practice was well tolerated, with no new safety signals, and associated with improved glycaemic control after 1 year.

Trial registration

ClinicalTrials.gov identifier, NCT02821052.

SUBMITTER: Katabami T

PROVIDER: S-EPMC8799571 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionIn this literature review we evaluated the real-world clinical effectiveness of switching Japanese diabetic patients from their current insulin regimen to insulin degludec (IDeg).MethodsStudies were identified from Japanese Diabetes Society (JDS) abstracts (2014-2015) and PubMed (2012 onwards). Inclusion criteria were: Japanese population, >15 participants, and studies switching patients from basal or basal-bolus insulin regimens to IDeg. Randomized controlled trials and case reports were excluded. Weighted mean changes in safety and effectiveness endpoints were calculated using the number of patients in each study.ResultsIn total, 81 JDS abstracts and seven manuscripts met the search criteria, representing 4238 patients [1028 with type 1 diabetes (T1D), 602 with type 2 diabetes (T2D), 2608 with unspecified or mixed diabetes]. Glycated hemoglobin (HbA1c) was reported in 93% of studies, with an improvement in 84% of these (51% significant, 33% numerical), no change in 12%, and worsening in 4% (3% numerical, 1% significant). Across all studies, the weighted mean absolute change in HbA1c was -0.3% (-2.7 mmol/mol). Basal insulin dose was reported in 58% of studies and was lower in 60% of these (30% significant, 30% numerical), numerically unchanged in 26%, and higher in 14% (2% significant, 12% numerical). The weighted mean change in basal insulin dose was -4.8% and -3.0% for all studies and for studies with only significant results, respectively. The weighted mean change in basal dose based on all studies was -8.9, -5.5, and -2.9% for the T1D, T2D, and unspecified patient populations, respectively. Hypoglycemia was recorded in 31% of the studies. After switching treatment to IDeg, 55% of studies reported decreased hypoglycemia, 29% no change, and 16% an increase. Quality of life (QoL) was measured in 11% of studies, of which 82% reported improved QoL after switching, and 18% reported no change in QoL.ConclusionSwitching from a conventional basal insulin to IDeg has the potential to improve HbA1c with a lower insulin dose. Switching to IDeg may also provide a reduced risk of hypoglycemia and improvement in QoL.FundingNovo Nordisk.