Soliqua 100/33 (lixisenatide/insulin glargine) / Zealand Pharma, Sanofi - LARVOL DELTA

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

Glycaemic outcomes when switching to iGlarLixi from premixed insulin (PI) in adults with type 2 diabetes by iGlarLixi pen subgroups: post hoc analysis of Soli-SWITCH (EASD 2025) - P4 | "In people with T2D switching from PI, glycaemic improvements were similar across iGlarLixi pen subgroups, despite differences in BL characteristics. This highlights the flexibility of iGlarLixi to adapt to insulin dose needs and optimise Lixi dosage."

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

Early glycaemic improvement when switching to iGlarLixi from premixed insulins in adults with type 2 diabetes: a post hoc analysis of Soli-SWITCH (EASD 2025) - P4 | "In adults with T2D who switched from PI to iGlarLixi, glycaemic control improved in the first weeks of transitioning (Weeks 0-3) and continued to improve to Week 12."

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

The efficacy and safety of iGlarLixi in insulin-naive adults with type 2 diabetes by baseline A1c and diabetes duration: posthoc analysis of Soli-CGM (EASD 2025) - P4 | "In adults with T2D, iGlarLixi improved the TIR without ADA Level 3 hypoglycemia, regardless of baseline HbA1c or diabetes duration."

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

Long-term effectiveness of iGlarLixi treatment in people with type 2 diabetes in the United States: The soli-durability 24-month observational study. (PubMed, Diabetes Obes Metab) - "iGlarLixi initiation was associated with improved glycaemic control, without body weight change or increased hypoglycaemia over 24 months."

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

A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P4 | N=105 | Recruiting | Sponsor: Sanofi | Trial completion date: Jul 2025 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ Apr 2026

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

Practical limitations of complex insulin therapies in type 2 diabetes: Focus on therapy simplification using fixed-ratio combinations of basal insulin and a glucagon-like peptide-1 receptor agonist. (PubMed, Diabetes Obes Metab) - "Current evidence suggests that this approach is equally efficient in terms of glycaemic control with the additional benefit of the reduction of body weight, total daily dose of insulin, and the number of insulin injections administered per day with no increase or reduction of hypoglycaemia. The primary aim of this review is to present the current evidence supporting the simplification of complex insulin regimens in PwT2DM with the two currently available FRCs on the market (insulin glargine 100 U/mL and GLP-1 RA lixisenatide [iGlarLixi] or insulin degludec and GLP-1 RA liraglutide [IDegLira]) and to provide a simple clinical practice-oriented algorithm for clinicians based on the currently available evidence."

Journal • Cardiovascular • Diabetes • Hypoglycemia • 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

An overview of randomized clinical trials of fixed-ratio combinations of basal insulin plus GLP-1RA (injectable therapy): Lessons for advancing therapy in people with type 2 diabetes. (PubMed, Diabetes Obes Metab) - "BI and GLP-1RAs can be administered separately or as fixed-ratio combinations (FRCs) for daily use (degludec+liraglutide, IDegLira, glargine-100 + lixisenatide iGlarLixi) or weekly use (icodec+semaglutide, IcoSema)...The weekly FRC IcoSema is superior to weekly insulin icodec (COMBINE 1), to semaglutide (COMBINE 2), and non-inferior to basal-bolus insulin therapy (COMBINE 3)...However, all FRCs are limited by the low GLP-1RA dose relative to the insulin delivered. Whenever higher GLP-1RA doses are required (i.e., in obese people), the option of separate dosing of BI and GLP-1RA with independent titration of each component should be considered."

Clinical • Journal • Atherosclerosis • Cardiovascular • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

What is the 'real-world' experience with fixed-ratio combination therapy (insulin + GLP-1 receptor agonist) in routine clinical practice? Take-home messages for clinicians regarding key outcomes. (PubMed, Diabetes Obes Metab) - "Collectively, these real-world studies confirm that FRCs are effective, safe and patient-centred treatment options for adults with T2D. Their simplified dosing, metabolic benefits and favourable safety profiles support their use for both therapy intensification and de-intensification across a broad spectrum of clinical scenarios. These findings reinforce results from randomized controlled trials, providing further confidence in the role of FRCs in contemporary diabetes care."

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

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 (European Medicines Agency) - "EMA’s safety committee (PRAC) has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1) - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and cancer of the thyroid (a small gland in the front and lower part of the neck which makes and releases hormones)....The MAHs for liraglutide- (including Victoza, Saxenda, Xultophy), semaglutide- (including Ozempic, Rybelsus, Wegovy), exenatide- (including Bydureon, Byetta), dulaglutide- (i.e.Trulicity) and lixisenatide- (including Lyxumia, Suliqua) containing products should continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs)."

European regulatory • Diabetes • Metabolic Disorders • Obesity • 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

Enhanced Glycemic Control and Weight Benefits of Insulin Glargine plus lixisenatide vs. Insulin Glargine in Type 2 Diabetes (ADA 2025) - "Insulin glargine + lixisenatide demonstrated superior glycemic control and weight benefits compared to insulin glargine in type 2 diabetes patients."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Efficacy and Safety of iGlarLixi in Insulin-Naïve Adults with Type 2 Diabetes (T2D) by Baseline Age, Sodium–Glucose Cotransporter 2 Inhibitor (SGLT2i) Use, and BMI—Post Hoc Analysis of Soli-CGM (ADA 2025) - P4 | "In adults with T2D, iGlarLixi increased TIR regardless of BL age, BMI and SGLT2i use."

Clinical • Retrospective data • 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

Efficacy and Safety of Switching to Iglarlixi from Premix Insulin Regimen in Patients with T2DM—Real-World Experience (ADA 2025) - "Switching from premix insulin to iGlarLixi in patients with T2DM serve as a safe and effective approach to simplify treatment complexity and improve glycemic control."

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

Glycemic Outcomes When Switching to iGlarLixi from Premixed Insulin (PI) in People with Type 2 Diabetes (T2D) by iGlarLixi Pen Subgroups—Post Hoc Analysis of Soli-SWITCH (ADA 2025) - P4 | "In people with T2D switching from PI, glycemic improvements were similar across iGlarLixi pen subgroups, despite differences in BL characteristics. This highlights the flexibility of iGlarLixi to adapt to insulin dose needs and optimize Lixi dosage."

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

Early Glycemic Improvement When Switching to iGlarLixi from Premixed Insulins (PI) in Adults with Type 2 Diabetes (T2D)—A Post Hoc Analysis of Soli-SWITCH (ADA 2025) - P4 | "In adults with T2D who switched from PI to iGlarLixi, glycemic control improved in the first weeks of transitioning (Weeks 0-3) and continued to improve to Week 12."

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

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

Current treatment guidelines and glycated haemoglobin goals for type 2 diabetes: Which patients are most likely to benefit from fixed-ratio basal insulin glucagon-like peptide-1 receptor agonist combinations? (PubMed, Diabetes Obes Metab) - "Basal insulin and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are available in two fixed-ratio combinations (FRCs) for the treatment of type 2 diabetes (T2D), insulin degludec with liraglutide and insulin glargine with lixisenatide. An HbA1c goal of <6.5% is less likely to be appropriate for patients requiring basal insulin, which is included in the FRCs. Ideal candidates for FRCs are those (1) taking oral antihyperglycemic medications only with an HbA1c <10% and <2% away from goal, (2) those on basal insulin and above HbA1c goal, (3) those unwilling or unable to initiate or manage multiple daily injections (i.e., basal-bolus insulin therapy) and (4) those tolerating a GLP-1 RA who require basal insulin to achieve glycemic goals."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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

Safety and clinical effectiveness of iGlarLixi in people with type 2 diabetes mellitus in Mexico. (PubMed, Diabetes Obes Metab) - "iGlarLixi demonstrated a consistent safety profile aligned with findings from previous randomised controlled trials. The most common ADRs were gastrointestinal disorders that were generally tolerable. Over 50% of participants treated with iGlarLixi achieved their glycaemic targets."

Journal • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Type 2 Diabetes Mellitus

INSULIN THERAPY DE-INTENSIFICATION WITH IGLARLIXI IN PEOPLE WITH TYPE 2 DIABETES: THE IDEAL RANDOMISED CONTROLLED TRIAL (ATTD 2025) - "The proportion of study visits at which hypoglycemia was reported was lower in the iGlarLixi vs MDI group (5.5% vs 9.6%, p=0.029). No differences in FPG and PPG were observed.Conclusions Insulin therapy de-intensification from MDI into iGlarLixi is an efficient and safe treatment option for PwT2D that provides comparable glycaemic control with the benefits of reduction of BW, TDD, number of insulin injections and lower proportion of visits as which hypoglycaemia was reported."

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

INSULIN TREATMENT SIMPLIFICATION WITH IGLARLIXI IN RELATIVELY WELL-CONTROLLED PATIENTS WITH TYPE 2 DIABETES (ATTD 2025) - "The percentage of patients reporting at least one episode of hypoglycemia at BV, V1, and V2 was 52.5%, 30.5%, and 22%. The mean dose of iGlarlixi at V1 and V2 was 21.8±8.3 and 22.1±8.7 dose steps.Conclusions Replacing complex insulin regimens with iGlarLixi in relatively well-controlled patients with T2D results in similar or better glycemic control with with lower insulin doses, fewer daily injections, less hypoglycemia and a favorable effect on body weight."

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