Diabetes Metab J.  2024 Sep;48(5):929-936. 10.4093/dmj.2023.0297.

Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus

• Kang S
• Ahn YB
• Oh TK
• Lee WY
• Chun SW
• Bae B
• Dahaoui A
• Jeong JS
• Jung S
• Jang HC

• KMID: 2559002
• DOI: http://doi.org/10.4093/dmj.2023.0297

Abstract

Background
This study investigated the real-world efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in Korean adults with type 2 diabetes mellitus (T2DM), whose insulin treatment was switched to IDegAsp.
Methods
This was a multicenter, retrospective, observational study comprising two 26-week treatment periods, before and after switching to IDegAsp, respectively. Korean adults with uncontrolled T2DM treated with basal or premix insulin (±oral antidiabetic drugs) were enrolled. The primary objective was to compare the degree of glycosylated hemoglobin (HbA1c) change in each 26-week observation period. The analyses included changes in HbA1c, fasting plasma glucose (FPG), body weight, proportion of participants achieving HbA1c <7.0%, hypoglycemic events, and total daily insulin dose (ClinicalTrials.gov, number NCT04656106).
Results
In total, 196 adults (mean age, 65.95 years; mean T2DM duration, 18.99 years) were analyzed. The change in both HbA1c and FPG were significantly different between the pre-switching and the post-switching period (0.28% vs. –0.51%, P<0.001; 5.21 mg/dL vs. –23.10 mg/dL, P=0.005), respectively. After switching, the rate of achieving HbA1c <7.0% was significantly improved (5.10% at baseline vs. 11.22% with IDegAsp, P=0.012). No significant differences (before vs. after switching) were observed in body weight change, and total daily insulin dose. The rates of overall and severe hypoglycemia were similar in the two periods.
Conclusion
In real-world clinical practice in Korea, the change of insulin regimen to IDegAsp was associated with an improvement in glycemic control without increase of hypoglycemia, supporting the use of IDegAsp for patients with T2DM uncontrolled with basal or premix insulin.

Keyword

Databases, factual; Diabetes mellitus, type 2; Glycemic control; Hypoglycemia; Insulin degludec, insulin aspart drug combination

Figure

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  Fig. 1. Changes in glycemic parameters between pre-switching and post-switching of insulin degludec/insulin aspart. Mean changes in glycosylated hemoglobin (HbA1c) (A), and fasting plasma glucose (B) in pre-switching and post-switching period, and proportions of patients who achieved HbA1c less than 7% and proportions of participants who achieved HbA1c less than 7% without any hypoglycemia (C) in week 0 and week 26. Full analysis set. FPG, fasting plasma glucose; CI, confidence interval.

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