Clinical Research out of Insulin Glargine U300 basal bolus therapy and Insulin Degludec/Aspart Co-Formulation in Type 2 Diabetes Mellitus: A Real World Experience

Abstract

Aims/Introduction: Insulin Degludec/Aspart (IDegAsp) and Insulin Glargine U300 (IGlarU300) have recently emerged as popular new-generation insulin analogs. The aim of this real-life study was to investigate the patient profiles in which IGlarU300 and IDegAsp were preferred and the insulin combinations after which each of them were mostly used, and also to analyze the effect of these two insulin analogs on blood glucose regulation and hypoglycemia. Materials and Methods: The retrospective study included 174 patients that were switched from basal insulin, basal+bolus insulin, or premixed insulin to IGlarU300 or IDegAsp due to uncontrolled blood glucose levels or history of hypoglycemia. Hypoglycemia, body weight, body mass index (BMI), fasting blood glucose (FBG), and HbA1c levels over three-month periods were evaluated for each patient. Results: There were 84 and 90 patients in the IGlarU300 and IDegAsp groups, respectively. Body weight was similar in both groups. Baseline FBG and HbA1c levels in the IGlarU300 and IDegAsp groups were 9.0%, 175.5 mg/dl and 9.4%, 193.5 mg/dl, respectively. A significant decrease was found in FBG and HbA1c levels in both groups (138.5, 7.8 vs. 141.5, 8.2; p<0.001 for all). Moreover, a significant weight gain was observed in both groups (p<0.05 for both). The prevalence of hypoglycemia in both groups decreased significantly and consistently between month 1 and 9 (p<0.001). At month 12, although this decrease continued in the IGlarU300 group (p=0.013), no significant decrease was observed in the IDegAsp group(p=0.057). Conclusion: Both twice-daily IDegAsp±bolus insulin and IGlarU300+bolus insulin therapies are effective and safe treatment modalities.

Clinical course of different long-acting insulin therapies—glargine U100, U300, degludec, and insulin degludec/insulin aspart—among Japanese patients with type 2 diabetes: a multicenter retrospective observational study (JDDM65 study)

“…It might therefore be difficult to find a clinical difference between Deg and IDegAsp containing 70% Deg. In addition, previous studies [12,13] found similarly effective treatment using both IDegAsp and Gla300. However, of note, compensation with a certain dose of bolus insulin might be expected to lead to more effective regulation of postprandial glucose level than other basal insulins, although attending physicians might have begun with higher initial doses for that reason, as observed in this study (Table 1).…”

“…Although it is common to start these long-acting insulins as the first step in insulin therapy for patients with T2D in an outpatient setting at clinics or hospitals, continuation of insulin therapy can represent a physical, clinical, and economic burden for patients. In addition, although several studies have compared the analogues for assessment of their effectiveness and safety [6][7][8][9][10][11][12][13][14], no comparative studies concerning the clinical course and withdrawal of the use of these four insulin types in outpatient settings have been published.…”

Efficacy of Insulin Degludec/Insulin Aspart (IDegAsp) vs. Insulin Glargine (IGlarU300) in Insulin-Naïve Patients with Type 2 Diabetes: A Retrospective Study

“…In the past, few studies have reported similar results. Kisioglu et al [20] observed a significant decrease in the HbA1c and creatinine levels of patients treated with IDegAsp and IGlarU300. Similarly, Heise et al [27] reported that insulin-naïve people with T2D subjected to once-daily IDegAsp versus once-daily IGlarU300 showed comparable significant improvement in glycemic control and low rates of hypoglycemia.…”

“…According to the RSSDI clinical practice recommendations for the management of T2D 2022, IDegAsp causes the least weight gain compared to basal insulin and other premixed insulin preparations [24]. PPBG -postprandial blood glucose However, Kisioglu et al [20] retrospectively observed significant weight gain in patients treated with IDegAsp and IGlarU300. Additionally, we observed a significant decrease in the mean creatinine values of both treatment groups from baseline, suggestive of improvement in kidney function or stabilization of kidney disease progression due to improved glycemic control.…”

“…On the other hand, IGlarU300 is the widely accepted basal ultra-long-acting second-generation insulin that provides a steady and sustained basal insulin level. Although the use of the co-formulation IDegAsp and IGlarU300 has been shown to lower FBG levels and frequency of hypoglycemia compared to other premix insulin preparations, no study or meta-analysis has compared the efficacy of IDegAsp and IGlarU300 in managing T2D in the Indian cohort [18][19][20]. A comparative efficacy study of both widely prescribed second-generation insulin analogs, IDegAsp versus IGlarU300, will elucidate the potential equivalent usage of either choice molecule as an insulin initiator in insulin-naïve patients with T2D.…”