Diabetes Metab J.  2020 Aug;44(4):532-541. 10.4093/dmj.2019.0093.

Switching to Once-Daily Insulin Degludec/Insulin Aspart from Basal Insulin Improves Postprandial Glycemia in Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial

• Cho KY
• Nakamura A
• Oba-Yamamoto C
• Tsuchida K
• Yanagiya S
• Manda N
• Kurihara Y
• Aoki S
• Atsumi T
• Miyoshi H

• KMID: 2513013
• DOI: http://doi.org/10.4093/dmj.2019.0093

Abstract

To explore the efficacy and safety of switching from once-daily basal insulin therapy to once-daily pre-meal injection insulin degludec/insulin aspart (IDegAsp) with respect to the glycemic control of participants with type 2 diabetes mellitus (T2DM).

In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, participants on basal insulin therapy were switched to IDegAsp (IDegAsp group; n=30) or continued basal insulin (Basal group; n=29). The primary endpoint was the superiority of IDegAsp in causing changes in the daily blood glucose profile, especially post-prandial blood glucose concentration after 12 weeks.

Blood glucose concentrations after dinner and before bedtime were lower in the IDegAsp group, and the improvement in blood glucose before bedtime was significantly greater in the IDegAsp group than in the Basal group at 12 weeks (−1.7±3.0 mmol/L vs. 0.3±2.1 mmol/L, P<0.05). Intriguingly, glycemic control after breakfast was not improved by IDegAsp injection before breakfast, in contrast to the favorable effect of injection before dinner on blood glucose after dinner. Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol, P<0.05). Changes in daily insulin dose, body mass, and recorded adverse effects, including hypoglycemia, were comparable between groups.

IDegAsp was more effective than basal insulin at reducing blood glucose after dinner and before bedtime, but did not increase the incidence of hypoglycemia. Switching from basal insulin to IDegAsp does not increase the burden on the patient and positively impacts glycemic control in patients with T2DM.

Keyword

Diabetes mellitus, type 2; Hypoglycemia; Insulin degludec; Insulin degludec, insulin aspart drug combination; Randomized controlled trial

Figure

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  Fig. 1 Study protocol flow diagram. IDegAsp, insulin degludec/insulin aspart; SMBG, self-measured blood glucose.

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  Fig. 2 Blood glucose concentrations at the end of the study. Seven-point self-monitoring of blood glucose was undertaken by participants in the insulin degludec/insulin aspart (IDegAsp) and Basal groups during the study periods. Data are mean±standard deviation. P values indicate comparisons between the IDegAsp and Basal groups. Unpaired t-test. aP<0.05.

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