Clinical considerations for use of insulin degludec/insulin aspart in Japanese patients

ABSTRACT

Introduction: Co-formulation of basal and bolus insulin components provides a simpler regimen for patients with type 2 diabetes than separate basal–bolus treatment. However, conventional premixed insulin products include a suboptimal protaminated basal component that requires resuspension prior to injection. Insulin degludec/insulin aspart (IDegAsp) is the first soluble co-formulation of a basal insulin with an ultra-long duration of action (IDeg) and a rapid-acting bolus insulin (IAsp) in a single injection.

Areas covered: In this review, the authors summarize findings from pre-clinical studies and the clinical trial program and provide guidance for the initiating and switching of IDegAsp in different patient populations. Pharmacodynamic analyses have revealed a rapid onset of action and distinct peak (IAsp), followed by a separate, flat and stable basal effect (IDeg component). Phase 3 studies have demonstrated the efficacy and safety of IDegAsp, with greater glycemic improvements than basal-only therapy in international and Japanese type 2 diabetes populations. IDegAsp also results in reduced insulin dose requirements and lower rates of hypoglycemia than premixed insulin.

Expert opinion: IDegAsp provides a simple and effective insulin regimen in appropriately selected Japanese patients, with the flexibility to suit individual needs. The benefits of IDegAsp over conventional insulin regimens might help tackle clinical inertia with insulin intensification.

KEYWORDS:

• (min. 4 required): hypoglycemia
• insulin degludec
• Japanese
• IDegAsp

Article highlights

• Insulin degludec/insulin aspart (IDegAsp) is the first soluble co-formulation of a basal insulin with an ultra-long duration of action (IDeg) and a rapid-acting bolus insulin (IAsp) in a single injection.

• Glucose infusion rate profiles show discrete prandial and basal effects of IDegAsp in Caucasian and Japanese patients, with a rapid onset of IAsp action, followed by a separate, flat and stable basal effect of IDeg.

• In Phase 3 trials, IDegAsp resulted in improved glycemic control, low rates of hypoglycemia and a low end-of-trial insulin dose in international and Japanese populations.

• It is straightforward to initiate and titrate IDegAsp, whether administered once or twice daily and whether switching from basal or premixed insulin.

• Further studies are required to evaluate the use of IDegAsp in routine clinical practice, and investigate whether it can help tackle clinical inertia.

This box summarizes key points contained in the article.

Acknowledgments

Medical writing and submission support were provided by Julie Sawyers, Victoria Atess, Richard McDonald and Beverly La Ferla of Watermeadow Medical, an Ashfield Company, part of UDG Healthcare plc.

Declaration of interest

T Hirose has been on advisory panels for Sanofi, Eli Lilly and Company and Novo Nordisk. He has received research support from Sanofi, Eli Lilly, Novo Nordisk, Takeda, Daiichi Sankyo, Mitsubishi Tanabe, Dainippon Sumitomo, Kissei, Boehringer Ingelheim, Astellas, Ono Pharmaceutical Ltd, AstraZeneca, Taisho Toyama, Novartis and Merck Sharp and Dohme (MSD). He has been on the speakers’ bureau for Sanofi, Eli Lilly, Novo Nordisk, Takeda, Mitsubishi Tanabe, MSD, Dainippon Sumitomo, Novartis, Kissei, Boehringer Ingelheim, Ono Pharmaceutical Co. Ltd and AstraZeneca. T Awata is on the advisory boards of, received speaker honoraria from, and received research grants from Novo Nordisk, MSD, Mitsubishi Tanabe Pharma, Astellas Pharma, Sanwa Kagaku Kenkyusho, Ono Pharmaceutical Co. Ltd, Eli Lilly, Sumitomo Dainippon Pharma and Novartis. Y Yamamoto is an employee of Novo Nordisk Pharma Ltd. while MP Hemmingsen is an employee and stockholder of Novo Nordisk Pharma Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance was utilized in the production of this manuscript and funded by Novo Nordisk. One reviewer served as a consultant and speaker for Novo Nordisk. However, this did not involve the product being discussed here.

Additional information

Funding

This study was supported by Novo Nordisk. Medical writing and submission support was funded by Novo Nordisk