DegludecPlus (insulin degludec/insulin aspart) / Novo Nordisk - LARVOL DELTA

Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM (clinicaltrials.gov) - P=N/A | N=218 | Completed | Sponsor: Beijing Hospital | Not yet recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2023 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of insulin degludec/aspart in patients with type 2 and type 1 diabetes mellitus: real-world evidence from Indonesia. (PubMed, Front Endocrinol (Lausanne)) - "Real-world studies on insulin degludec/aspart (IDegAsp) have been conducted in some Southeast Asian populations; however, data specific to Indonesia remain limited. IDegAsp demonstrated sustained glycemic improvement at 3-, 6-, and 12-months follow-ups with a favorable safety profile over one year, in both T1DM and T2DM populations in Indonesia. These findings support its utility in routine clinical practice, particularly among patients with unmet glycemic targets or complex treatment needs."

HEOR • Journal • Real-world evidence • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Early Glycemic Control With iGlarLixi Versus IDegAsp in Chinese Adults With Type 2 Diabetes: A Post Hoc Analysis of the Soli-D Study. (PubMed, J Diabetes) - No abstract available

Journal • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 vs originator insulin degludec/insulin aspart in Chinese patients with type 2 diabetes inadequately controlled on basal or premixed insulin: A multicenter, randomized, open-label, phase 3 study. (PubMed, J Diabetes Investig) - "HS-IDegAsp demonstrated comparable efficacy and safety to NN-IDegAsp during the 24-week treatment period in Chinese patients with inadequately controlled T2DM previously treated on once- or twice-daily premixed or basal insulin, with or without OADs."

Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of iGlarLixi versus IDegAsp by baseline β-cell function in Chinese people with type 2 diabetes: Exploratory analyses of the Soli-D study. (PubMed, Diabetes Obes Metab) - "iGlarLixi provides improved glycaemic control at lower insulin daily doses compared with IDegAsp, regardless of C-peptide or HOMA-β levels, in Chinese people with uncontrolled T2D on OADs."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes (clinicaltrials.gov) - P4 | N=324 | Not yet recruiting | Sponsor: Yanbing Li

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Impact of time of injection on the efficacy and safety of iGlarLixi vs IDegAsp in Chinese people with type 2 diabetes: exploratory analysis of the Soli-D study (EASD 2025) - P3 | "Clinical Trial Registration Number: NCT05413369 Background and aims: The Soli-D study demonstrated better glycaemic control and body weight (BW) benefits with iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide, vs a fixed-ratio of insulin degludec + insulin aspart (IDegAsp) at 24 weeks in Chinese adults with type 2 diabetes (T2D) suboptimally controlled with glucose-lowering oral agents (OADs)... iGlarLixi injected before breakfast demonstrated better HbA1c and average 2-h PPG control compared with IDegAsp in T2D Chinese adults suboptimally controlled with OADs, regardless of IDegAsp injection time, while also providing better overall glycaemic control and BW benefits with lower insulin doses and less hypoglycaemia risk."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Glycemic Benefit of Insulin Degludec/Insulin Aspart Compared to Basal Insulin in Type 2 Diabetes Mellitus Associated with Impaired Glucagon-Like Peptide-1 Response: A Randomized Crossover Trial. (PubMed, Diabetes Metab J) - "The HbA1c benefit of IDegAsp over IGlar was associated with a low glucagon-like peptide-1 (GLP-1) ratio at 30 minutes relative to baseline (r=0.301, P=0.040), while not with glucose-dependent insulinotropic polypeptide. The greater reduction in HbA1c achieved with IDegAsp compared to IGlar in individuals with T2DM was associated with an impaired GLP-1 response, facilitating personalized insulin therapy."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Switching to insulin degludec/aspart penfill reusable cartridges in patients with type 2 diabetes mellitus: real-life outcomes. (PubMed, Diabetol Metab Syndr) - "Initiating or switching to the IDegAsp reusable pen with the insulin cartridge system in a real-world population of people with T2D in Türkiye was associated with improved or maintained glycemic control."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluation of efficacy of iGlarLixi versus IDegAsp using derived time-in-ranges in Chinese adults with Type 2 diabetes: A post hoc analysis of the Soli-D study. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Impact of Time of Injection Comparing iGlarLixi vs. IDegAsp in Chinese People with Type 2 Diabetes—Exploratory Analysis of the SoliD Study (ADA 2025) - P3 | "iGlarLixi confirmed better glycemic control and body weight benefits with lower insulin doses and less hypoglycemia risk vs IDegAsp regardless of IDegAsp injection time."

Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of IGlarLixi vs. IDegAsp by Baseline HbA1c in Chinese People with T2D—Post Hoc Analyses of the SoliD Study (ADA 2025) - "In this post hoc analysis, regardless of baseline HbA1c level, iGlarLixi demonstrated better clinical outcomes vs IDegAsp. Results from this analysis are consistent with primary results reported previously."

Clinical • Retrospective data • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

GZR101, a Novel Premixed Insulin for the Treatment of Diabetes Mellitus. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This study evaluated insulin GZR33 (GZR33), an ultra-long basal insulin, and insulin GZR101 (GZR101), which is a premix of GZR33 and postprandial insulin aspart...Potency was tested in vivo in streptozotocin-induced T1DM rats and db/db T2DM mice, using insulin degludec (degludec, IDeg) and insulin degludec/insulin aspart (IDegAsp) as controls...Therefore, GZR101 provides a promising once-daily premixed insulin candidate with potential to enhance glycemic control and patient adherence. Clinical trial number: not applicable."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • IR

Choice of Insulin Coformulations: Biphasic Insulin Versus Insulin-GlP1RA. (PubMed, J Pak Med Assoc) - "A comprehensive evaluation,including severity and style of glycaemia, clinical presentation, comorbidities, complications, and culinary preference, allows efficient choice of insulin formulation. This framework helps in initiation,intensification and interchange of injectable therapy,in an apt, and ept, manner."

Journal

Insulin degludec/insulin aspart (IDegAsp) treatment on glycemic control and weight in patients with insulin experienced uncontrolled type 2 diabetes mellitus: A retrospective observational study. (PubMed, Endocr Regul) - "IDegAsp can provide a significant decrease in HbA1c in a real-life setting. Although weight gain was observed in the first months of the treatment, this effect disappeared over time and decreased to the baseline levels."

Journal • Observational data • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluation of Pharmacokinetics and Safety of the Biosimilar (B01711) and Insulin Degludec/Insulin Aspart (IDegAsp, Ryzodeg) in Healthy Chinese Adults in a Randomized, Open-Label, Single-Dose, Crossover, Phase I Study. (PubMed, Drug Des Devel Ther) - "The adverse events (AEs) of hypokalemia and hypoglycemia were identified as treatment-related AEs (TRAEs) and all TRAEs were mild. This study demonstrated the PK equivalence of the two drugs and confirmed that both were well-tolerated."

Clinical • Journal • P1 data • PK/PD data • Hypoglycemia

Efficacy and safety of iGlarLixi versus IDegAsp in people with type 2 diabetes inadequately controlled with basal insulin: A systematic literature review and network meta-analysis of non-Asian studies. (PubMed, Diabetes Obes Metab) - "Once-daily iGlarLixi was associated with superior blood glucose control and body weight benefit compared with IDegAsp in insulin-experienced populations with T2D in non-Asian RCTs."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluation of pharmacokinetic and pharmacodynamic similarity of an IDegAsp biosimilar versus the originator in healthy Chinese volunteers. (PubMed, Expert Opin Investig Drugs) - "Adverse events were similar for both products and no significant safety concerns were noted in the laboratory results, vital signs, or electrocardiogram. This study demonstrated the PK/PD similarity of 22,011 to Ryzodeg with a comparable safety profile."

Journal • PK/PD data

A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Enrolling by invitation ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy, safety and treatment satisfaction of transition to a regimen of insulin degludec/aspart: A pilot study. (PubMed, World J Diabetes) - "The present findings suggest that treatment with IDegAsp enhances clinical outcomes, particularly FBG levels, daily cumulative insulin dose, and overall satisfaction with diabetes treatment."

Clinical • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Severe palmoplantar keratoderma: a cutaneous complication from sub-optimally controlled type 2 diabetes. (PubMed, Endocrinol Diabetes Metab Case Rep) - "Treatment included an insulin-dextrose infusion until DKA resolved, followed by twice daily insulin degludec/aspart (Ryzodeg 70/30) and metformin. The PPK was attributed likely secondary to sub-optimally managed diabetes. Diabetes mellitus has multiple complications, including rare dermatologic manifestations such as PPK.This case illustrates the importance of thorough skin assessments in patients with diabetes, particularly those that have a history of sub-optimal diabetes control.A multidisciplinary approach, integrating dermatology, endocrinology and allied health services such as podiatry, is essential in managing diabetes-related complications, improving patient quality of life and preventing further complex manifestations."

Journal • Dermatology • Diabetes • Endocrine Disorders • Infectious Disease • Metabolic Disorders • Type 2 Diabetes Mellitus

Improved glycaemic control in people with type 2 diabetes initiating or switching to IDegAsp in a real-world setting in China. (PubMed, Diabetes Obes Metab) - "In a broad, real-world Chinese population of adults with T2D, initiating or switching to IDegAsp was associated with improved glycaemic control and lower rates of hypoglycaemia. The use of IDegAsp could be an effective treatment option for those with suboptimal glycaemic control or therapeutic inertia."

Journal • Real-world • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults With Type 2 Diabetes in the Philippines: Results from a Prospective, Non-interventional, Real-World Study. (PubMed, J ASEAN Fed Endocr Soc) - "Initiating or switching to IDegAsp was associated with improved glycemic control, lower body weight, and lower HRU for people with T2D in the Philippines. No new, unexpected AEs were reported."

Journal • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Survey of fear and compliance of Insulin Degludec and Insulin Aspart injection in type 2 diabetes mellitus patients and analysis of influencing factors. (PubMed, Medicine (Baltimore)) - "This study aims to investigate the fear and compliance of Insulin Degludec and Insulin Aspart (IDegAsp) injection in type 2 diabetes mellitus (T2DM) patients and study the factors influencing patient compliance. Educational level, disease duration, complications, cognitive level, self-efficacy level, comorbidity count, and living status are important factors affecting the fear and treatment compliance of IDegAsp injection in T2DM patients. These findings have implications for improving patient compliance and alleviating treatment fear."

Compliance • Journal • Observational data • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Initiation or switch to insulin degludec/insulin aspart in adults with type 2 diabetes in India: Results from a prospective, non-interventional, real-world study. (PubMed, J Family Med Prim Care) - P | "This was accompanied by a numerical reduction in resource utilization and patient-reported hypoglycaemia. Clinical trial registration: NCT04042441."

Journal • Real-world • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus