BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk - LARVOL DELTA

OPTIMISE-GDM: Optisulin vs NovoMix30 insulin in pregnant women with gestational diabetes (ANZCTR) - P4 | N=210 | Not yet recruiting | Sponsor: Canberra Hospital Department of Endocrinology

New P4 trial • Diabetes • Gestational Diabetes • Metabolic Disorders

Insights into the Structural Coexistence of Hexameric States in Microcrystalline Insulin Formulations in the Solid State. (PubMed, Mol Pharm) - "Recombinant human insulin powder was compared with three commercial Neutral Protamine Hagedorn (NPH) crystalline suspensions: Humulin 70/30, Insugen 70/30, and NovoMix 30. The NovoMix 30 formulation (insulin aspart) exhibits further line broadening, consistent with increased lattice disorder introduced by the ProB28 → Asp substitution. These observations illustrate how solid-state NMR can resolve formulation-dependent conformational heterogeneity and provide structural support for biosimilarity evaluation in solid-state protein therapeutics."

Journal

Euglycaemic ketoacidosis after initiation of tirzepatide in a patient on chronic SGLT2 inhibition and intercurrent colitis (UKKW 2026) - "Case A 44-year-old woman with type 2 diabetes, multiple sclerosis, and coronary artery disease had been on canagliflozin since January 2021...She was discharged on 23 July 2025 on NovoMix 30 insulin (12 units AM, 10 units PM)...Next step Renal services should implement peri-procedure protocols including early suspension of SGLT2i/tirzepatide, ketone-first monitoring, and insulin–dextrose bridging. National audit is needed to quantify incidence, refine drug-hold intervals, and establish euDKA prevention as a measurable NHS safety standard."

Clinical • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Coronary Artery Disease • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Multiple Sclerosis • Nephrology • Septic Shock • Type 2 Diabetes Mellitus

Efficacy and Safety of Insulin Degludec/Insulin Aspart versus Biphasic Insulin Aspart 30 in Patients with Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Iran J Public Health) - "However, there was no significant difference in the improvement of body weight change (P=0.99), glycosylated hemoglobin (P=0.50), the overall risk of hypoglycemic events (P=0.57) and adverse events (P=0.89) between the two groups. Compared with BIAsp30, IDegAsp could significantly reduce FPG levels, insulin dosage, and the risk of nocturnal hypoglycemic events in T2D patients, without increasing the overall risk of adverse events."

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

Glycaemic outcomes in hospital with IDegAsp versus BIAsp30 premixed insulins. (PubMed, Intern Med J) - "Inpatients treated with IDegAsp compared to BIAsp30 had similar hypoglycaemia incidence, but higher hyperglycaemia incidence, potentially related to less frequent twice-daily dosing. With the increasing use of IDegAsp in the community, development of hospital management guidelines for this insulin formulation is needed."

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

Real-world study of the concomitant use of biphasic insulin as part 30/70 with GLP-1 receptor agonist versus first-generation basal insulin with GLP-1 receptor agonist in type 2 diabetes. (PubMed, Diabet Med) - "Combining BIAsp 30 + GLP-1RA provides glycaemic control with no significant difference to that of propensity score-matched people receiving basal insulin+GLP-1RA, with no increase in hypoglycaemia risk or weight gain."

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

Bioequivalence of Reference and Biosimilar Preparations of Premixed Biphasic Insulin Aspart: A Comparative Clamp Study. (PubMed, Clin Pharmacol Drug Dev) - "Biphasic insulin aspart 30 is a premixed formulation containing a soluble fraction of insulin aspart (30%) and a protamine-crystallized fraction (70%) that was developed to combine the rapid-acting and prolonged advantages of commercially available insulins...The 90% confidence intervals for the geometric mean ratios of PK (C and AUC ) parameters of Gp-bi-asp and Novo-bi-asp were close to 100% and within the 80%-125% limits for establishing bioequivalence. The safety profiles of both drugs were also comparable."

Clinical • Journal

Budget Impact Analysis of IDegAsp for the Management of Type 2 Diabetes in Saudi Arabia (ISPOR-EU 2023) - "OBJECTIVES: To evaluate the budget impact of replacing BIAsp30 (Biphasic insulin aspart 30/70) by IDegAsp (insulin degludec+insulin aspart) in the management of type 2 diabetes mellitus (T2DM) from a Saudi Arabia public payer perspective. IDegAsp insulin reduces the risk of hypoglycaemia, resulting in budget savings for public Saudi payers. Hypoglycaemia and its associated costs may justify the price difference between the two comparators."

HEOR • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Glycaemic control and weight outcomes after adding or switching to biphasic insulin aspart 30/70 in people with type 2 diabetes mellitus previously treated with basal-bolus insulin in UK clinical practice. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Real-world study of ethnic differences in glycaemic control and clinical characteristics among insulin-naïve people with type 2 diabetes initiating biphasic insulin aspart 30/70: A retrospective, observational cohort study in England. (PubMed, Diabetes Obes Metab) - "Among insulin-naïve people with T2D initiating BIAsp 30, clinically meaningful HbA1c reductions in all ethnicities were observed. Some ethnic groups had larger reductions than others, but differences were small. In all groups, small BMI increases were seen, with small differences observed between groups. Hypoglycaemia rates were low."

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

Influence of hypoglycaemia on insulin titration and fasting plasma glucose in type 2 diabetes treated with basal-supported oral therapy (BOT): a sub-analysis of the SoliMix study (DDG 2023) - P3 | "More frequent hypoglycemia with BIAsp 30 than with iGlarLixi may result in lower insulin doses, which can make insulin titration more difficult and lead to higher fasting plasma glucose levels. Encore Submission. EudraCT number: 2017-003370-13."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Therapy intensification in type 2 diabetes treated with basal-supported oral therapy (BOT): exploratory analysis of the SoliMix study according to HbA1c, insulin dose and BMI at the start of the study (DDG 2023) - P3 | "The primary SoliMix results for iGlarLixi vs. BIAsp 30 were consistent between baseline HbA1c and BMI subgroups, but inconsistent for baseline insulin dose. Encore Submission."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Therapy intensification in type 2 diabetes treated with basal-supported oral therapy (BOT): exploratory analysis of the SoliMix study according to age, diabetes duration and renal function at the start of the study (DDG 2023) - P3 | "The primary results for iGlarLixi vs. BIAsp 30 were not affected by age, T2D duration, or baseline renal function. Encore Submission."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries. (PubMed, Diabetes Obes Metab) - P3 | "Once-daily iGlarLixi provided better glycaemic control with weight benefit and less hypoglycaemia than twice-daily premix BIAsp 30. iGlarLixi may be a favourable alternative to premix BIAsp 30 in people with suboptimally controlled T2D to advance BI therapy in the LATAM region."

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

Glycaemia in low-premixed insulin analogue type 2 diabetes patients in a real-world setting: are the CGM targets met? (PubMed, Eur J Med Res) - "Most of our type 2 diabetes patients, treated with low-premixed insulin, did not meet the recommended TBR target for older/high-risk patients while meeting the TIR and TAR targets. Nevertheless, the time spent in (total and nocturnal) hypoglycemia was short. The study indicates that the general type 2 diabetes population targets would mostly be met for TBR and %CV in our patients but not the TIR and TAR targets. CGM appears to be a useful clinical tool in these patients."

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

Mixed insulin can improve control of prednisolone-induced hyperglycaemia. (PubMed, Intern Med J) - "Mixed insulin as a pre-breakfast or pre-breakfast and pre-lunch regimen can target the hyperglycaemic pattern induced by prednisolone and minimise overnight hypoglycaemia. However, higher doses of insulin than used in our study are likely required for optimal BGL control."

Journal • Diabetes • Hypoglycemia

"@novonordisk Can you recycle your Novomix 30 insulin pens? If so, how & where?" (,@STEVEFI14205588)

Cost Per Responder and Number Needed to Treat of iGlarlixi vs Premix BIAsp 30 in Algerian Setting (ISPOR-EU 2022) - "Based on the data from SoliMix trial, iGlarLixi is more effective than BIAsp 30 BID in terms of bringing patients to targets, both HbA1c-focused & multifactorial. While iGlarLixi was associated with increased treatment costs, the cost per responder was lower than premix BIAsp 30 when considering all treatment effect. This analysis suggests iGlarLixi is an efficient alternative in Algeria"

Hypoglycemia • Type 2 Diabetes Mellitus

Cost-effectiveness of insulin degludec/insulin aspart versus biphasic insulin aspart in Chinese population with type 2 diabetes. (PubMed, Front Public Health) - P3 | "Results were robust across a range of sensitivity analyses. Compared with BIAsp 30, IDegAsp was a cost-effective treatment option for people with T2DM with inadequate glycemic management on basal insulin in China."

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

Findings for iGlarLixi vs BIAsp 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics. (PubMed, Diabetes Obes Metab) - P3 | "Treatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes, and renal function, supporting the use of iGlarLixi as an efficacious and well-tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics."

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

Pharmacokinetic Similarity between Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 and Originator Insulin Aspart Mix 70/30 (NovoMix 30) in Indian Adults with Type 2 Diabetes: GEMELLI M Substudy. (PubMed, Indian J Endocrinol Metab) - "Other efficacy endpoints, insulin dosages, anti-insulin aspart antibody response, hypoglycemia and adverse events were similar between groups. Our results support the findings from previous studies, that SAR-Mix has a similar pharmacokinetic profile to NN-Mix and provides effective glycemic control with similar safety and immunogenicity profile in Indian adults with type 2 diabetes."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Impact of hypoglycaemia on insulin titration and fasting plasma glucose in basal insulin-treated type 2 diabetes: a subanalysis of the SoliMix trial (EASD 2022) - P3 | "More frequent hypoglycaemia with premix BIAsp 30 than with iGlarLixi may result in lower insulin doses, thus hampering insulin titration and resulting in higher FPG."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial. (PubMed, Diabetes Obes Metab) - P3 | "In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs."

Journal • Patient reported outcomes • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Hypoglycaemia events with iGlarLixi versus premix biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes advancing from basal insulin: An analysis of the SoliMix trial. (PubMed, Diabetes Obes Metab) - "These results show that the lower HbA1c levels and weight benefit seen with iGlarLixi versus premixed BIAsp 30 in people with type 2 diabetes advancing their basal insulin therapy in the SoliMix trial are also accompanied by a lower risk of hypoglycaemia at any time of day and across a broad range of HbA1c levels."

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

PKPD Modeling and Simulations to Support Biosimilar Development of Biphasic Insulin Aspart 30. (PubMed, Clin Pharmacol Drug Dev) - "As a result, using real data along with model-based simulation data, a biosimilarity test for PD was performed, and the lower limit for became 82.6%, while the CV decreased from 31.7% to 24.1%. Thus, popPKPD modeling and simulations have been shown to be effective in interpreting and supporting the results of clinical biosimilarity trials."

Journal