IDegAsp is the first co-formulation of long-acting basal insulin with a rapid-acting mealtime insulin in one pen approved for use in patients with type 1 diabetes and type 2 diabetes (T2DM) 

The IDegAsp clinical trial program (BOOST) clinical investigation programme for patients with diabetes assessed the safety and efficacy of once or twice daily administration of IDegAsp using 26-week-long treat-to-target studies.

This co-formulation of insulin degludec (70%) and insulin aspart (30%) provides both long, flat, and stable basal glucose-lowering effect and prandial insulin coverage. In addition, IDegAsp offers less complexity with fewer injections. IDegAsp does not require re-suspension, enabling reliable and accurate dosing.  

The IDegAsp clinical trial program (BOOST) clinical investigation programme for patients with diabetes assessed the safety and efficacy of once or twice daily administration of IDegAsp using 26-week-long treat-to-target studies.  

IDegAsp effectively improved glycaemic control and overcame most of the limitations associated with the use of pre-mix or basal-bolus insulin regimens and demonstrated a simpler titration regimen. 

The ASPIRE study investigated the effect of IDegAsp on glycaemic control in a real-world population of patients (n=1102) with T2DM who have initiated or switched to IDegAsp from previous anti-hyperglycaemic treatment according to local clinical practice.  

The primary endpoint is change in HbA1c from baseline (week 0) to the end of study (the first visit within the window of week 26–36). The secondary endpoints include change in fasting plasma glucose level and body weight from baseline to the end of the study.  

An exploratory endpoint of the study to help clinicians selecting better treatment care in this population was the proportion of patients achieving HbA1c<7% without hypoglycaemia.  

ARISE enrolled T2DM patients from six countries (Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa). Adults with T2DM using any glucose-lowering agents and who were suitable for IDegAsp treatment at their physician’s discretion were enrolled.   

The top four reasons given by physicians for a switch to IDegAsp included: 

  • To improve patient’s glycaemic control 
  • To lower the risk of hypoglycaemia 
  • The flexibility of the dosing regimen 
  • Fewer injections required that basal and bolus insulin. 
  • What the study found 

    In the ARISE study, initiation with or switch to IDegAsp, led to: 

    • Significant decrease in HbA1c: An overall change from mean baseline (9.7%) to a mean of 8.3% 
    • Significant decrease in overall fasting plasma glucose: An overall mean change from 10.9% to 8.2%  
    • Decrease in body weight: Patients lost a mean of 1kg weight from baseline   
    • Lower daily basal but higher prandial insulin dose for previous insulin users
    • Numerical reductions in severe hypoglycaemic events (except  GLP-1RA prior users): From 51 (n=31) to three (n=3) at the end of the study
    • Decrease in resource utilisation observed 12 weeks prior to the end of the study: 
      • Self-reported outpatient visits decreased from 1012 to 498  
      • Emergency visits decreased from 35 to 12  
      • Self-reported missed workdays decreased from 242 to 28. 
      •  At baseline, only 4.3% of patients reached the recommended HbA1c target of <7%. At the end of the study, 14.9% of patients managed to reach target.  

        REFERENCES: 

        1. Fulcher GR, Jarlov H, Piltoft JS, et al. ARISE—a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: rationale and design, Endocrine (2021). 
        2. Fulcher GR, Akhtar A, Al-Jaser SJ, et al. Improved glycaemic control in people with type 2 diabetes initiating or switching to IDegAsp from any anti-hyperglycaemic treatment in a real-world setting across six countries. Presented at the Australasian Diabetes Congress (ADC) virtual meeting, 11–13 August 2021.