Efficacy and safety of insulin degludec U100 and insulin glargine U100 in combination with meal-time bolus insulin in hospitalized patients with type 2 diabetes: an open-label, randomized controlled study

Abstract

The short-term efficacy and safety of insulin degludec U100 (IDeg) in patients with type 2 diabetes have not been reported widely. We compared insulin IDeg and insulin glargine U100 (IGla) for glycemic control and glucose variability in hospitalized patients with type 2 diabetes. In an open-label, multicenter, randomized controlled trial, 74 patients were randomly assigned to either the IDeg (36 patients) or IGla (38 patients) group and were administered with basal-bolus therapy during hospitalization. Following the start of the treatment, on day 11, glucose variability was assessed by continuous glucose monitoring. A fasting blood glucose level of 110 mg/dL and 2-hour postprandial blood glucose level of 180 mg/dL throughout at least one day during the observation period were achieved in 31.3% (10/32) and 30.6% (11/36) of the patients in the IDeg and IGla groups, respectively. The 6-point self-monitoring of blood glucose profiles showed a significant difference between the two groups. On day 7, the intra-day variation was larger in the IDeg group than in the IGla group. The incidence of hypoglycemia or glucose variability was comparable in the two groups. This study suggests that short-term efficacy and safety of IDeg and IGla in patients with type 2 diabetes during the initial phase of basal-bolus therapy were comparable, and these results can help in deciding which treatment to opt for.

Comparisons of efficacy and safety in insulin glargine and lixisenatide plus glulisine combination therapy with multiple daily injection therapy in Japanese patients with type 2 diabetes

“…Regarding the titration period, in a study, in which inpatients were treated with MDI using Gla-100, the mean titration period to achieve the target glucose level by titrating according to the algorithm was 8.0 days 37 , which was similar to the average of 7.8 days for the MDI group in the present study. In contrast, the mean titration period of the iGlarLixi group was 6.0 days, which was significantly shorter than that of the MDI group.…”

The Safety and Efficacy of Second-Generation Basal Insulin Analogues in Adults with Type 2 Diabetes at Risk of Hypoglycemia and Use in Other Special Populations: A Narrative Review

“…The incidence of hypoglycemia (54 to ≤ 70 mg/dL) during the introduction of insulin was low and not statistically significant between IDeg- and Gla-100-treated patients (40.6 vs. 41.7%, respectively). Similarly, there was no significant difference in the incidence of severe hypoglycemia (< 54 mg/dL) between the two groups (9.4 vs. 11.1%, respectively; p = 0.782) [ 86 ].…”

Considerations for Insulin-Treated Type 2 Diabetes Patients During Hospitalization: A Narrative Review of What We Need to Know in the Age of Second-Generation Basal Insulin Analogs

“…After 12 days, the percentage of patients achieving glycemic control was similar between groups (~ 30%), as was the proportion experiencing hypoglycemia [~ 41%, BG 54–70 mg/dl (3.0–3.9 mmol/l), ~ 10% BG < 54 mg/dl (3.0 mmol/l)]. The glycemic targets and protocol used here are likely unsuitable for hospitalized patients, but it is reassuring that there was no increased risk of hypoglycemia with degludec versus glargine U100 [ 50 ]. Furthermore, a study in 12 patients who had a 24-h fasting period around their scheduled colonoscopy found patients could avoid hypoglycemia by skipping a single dose of degludec on the morning of the procedure [ 51 ].…”

“…Findings from a small ( n = 74), open-label, randomized, controlled trial conducted in Japanese hospitals have recently been published, albeit the patients were hospitalized for the specific purpose of initiating insulin; hence, the findings are not applicable to patients hospitalized as a result of acute illness/scheduled surgery. Nevertheless, this study provides insights into titrating degludec to target over a short period of time [ 50 ]. In this study, patients with poorly controlled (HbA 1c ≥ 8% [64 mmol/mol]) T2D were randomized to receive either degludec or glargine U100 as part of a basal–bolus regimen.…”