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

IMPACT OF TIME OF INJECTION COMPARING IGLARLIXI VS IDEGASP IN CHINESE PEOPLE WITH T2D: EXPLORATORY ANALYSIS OF SOLID STUDY (ATTD 2026) - P3 | "iGlarLixi confirmed better glycaemic control and body weight benefits with lower insulin doses and less hypoglycaemia risk vs IDegAsp regardless of IDegAsp injection time. Funded by Sanofi. Previously presented at ADA and EASD."

Hypoglycemia • Type 2 Diabetes Mellitus

EFFICACY OF IGLARLIXI VERSUS IDEGASP IN CHINESE PEOPLE WITH T2D BY HBA1C TARGET AT END-OF-TREATMENT AND BASELINE POSTPRANDIAL GLUCOSE: A POST-HOC ANALYSIS OF SOLI-D STUDY (ATTD 2026) - P3 | "This post-hoc analysis assessed efficacy and safety of iGlarLixi by HbA1c target achievement and number of participants achieving postprandial glucose (PPG) target at end-of-treatment (EOT). In Soli-D (NCT05413369), Phase-3, 24-week study, insulin-naïve Chinese-adults were randomised 1:1 to receive either iGlarLixi or IDegAsp, with metformin±SGLT-2i. More participants receiving iGlarLixi than IDegAsp achieved HbA1c, PPG targets, body-weight benefit and fewer hypoglycaemic events at EOT. Moreover, in people not achieving HbA1c ≤7%, iGlarLixi could be better titrated as the number of hypoglycaemia events was low."

Clinical • Retrospective data • Hypoglycemia • Type 2 Diabetes Mellitus

A LIFETIME COST-UTILITY ANALYSIS OF IGLARLIXI VERSUS IDEGASP IN TYPE 2 DIABETES IN TURKIYE (ISPOR 2026) - "iGlarLixi is a cost-effective option compared to iDegAsp for uncontrolled T2D in Turkiye,delivering additional life years and QALYs at an acceptable cost.Given the favorable cost-effectiveness of iGlarLixi in patients below the current BMI ≥35 reimbursement cutoff,policymakers could broaden their perspective in the reimbursement restrictions to enhance patient access to newer treatments"

HEOR • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

NN1535-8377: A research study to see how weekly IcoSema controls blood sugar levels when compared with daily insulin degludec/insulin aspart (IDegAsp) in people with poorly controlled type 2 diabetes (COMBINE 5) (clinicaltrialsregister.eu) - P2/3 | N=72 | Completed | Sponsor: Novo Nordisk A/S

New P2/3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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