Apidra (insulin glulisine) / Sanofi - LARVOL DELTA

Comparative Study of Non-Inferiority Immunogenicity of GP40321 and Apidra ® SoloStar ® in Type 1 Diabetes Mellitus Patients (clinicaltrials.gov) - P3 | N=224 | Completed | Sponsor: Geropharm

New P3 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Aging with type 1 diabetes: a perspective on "octagenarians" living with type 1 diabetes in Italy (EASD 2025) - "Among patients treated with the conventional basal-bolus insulin regimen, most (76.5%) were treated with second-generation basal insulin (glargine U300 or degludec). The most used rapid insulin analogues were lispro (44%), aspart (32.4%), glulisine (10%), and faster aspart (11.9%)... Many people with type 1 diabetes have aged, becoming 'octogenarians' by being regularly followed up in Italian diabetes centers. The overall quality of care for patients regularly followed up has resulted in a lower-than-expected burden of end-stage renal disease, visual loss, and diabetic foot. Management of CV risk factors could be improved."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Comparison of Efficacy of Short-Acting Human Insulin and Fast-Acting Insulin Analog after High- and Low-Carbohydrate Meal—Do the Pharmacokinetic Differences Matter? (ADA 2025) - "Therefore, their pharmacokinetic profile would rather reflect glycemic profile after high-carbohydrate meal (HCM), whereas delayed and longer action of SHI would rather reflect glycemia after low-carbohydrate meal (LCM). In a cross-over, open label study we administered SHI (Gensulin R, Bioton) or FIA (Apidra, Sanofi), both in the same dose 15 minutes before high- and low-carbohydrate standard morning meal, in a random sequence during four days, in 30 insulin-treated persons with type 2 diabetes. The results suggest that in persons with type 2 diabetes the composition of meal may be more important to achieve better postprandial glucose values and better glucose control than use of fast-acting insulin analog instead of short-acting human insulin."

Clinical • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effects of regular, glulisine, and aspart insulin on vascular endothelial growth factor and angiotensinogen expression in hyperglycemic retinal pigment epithelial (RPE) and human retinal endothelial cells (HRECs). (PubMed, Front Ophthalmol (Lausanne)) - "These findings highlight the differential biological effects of insulin analogues and suggest that aspart insulin, in particular, may offer therapeutic benefits beyond glycemic control by modulating both VEGF-A and RAS-related pathways. Tailored insulin therapies could represent innovative strategies for managing or slowing the progression of diabetic retinopathy."

Journal • Diabetes • Diabetic Retinopathy • Retinal Disorders • VEGFA

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Mannkind Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

IMPROVEMENT OF GLYCEMIA IN A PATIENT WITH TYPE 1 DIABETES ON PERITONEAL DIALYSIS ON AN INSULIN PUMP WITH AN ADVANCED HYBRID CLOSED-LOOP SYSTEM (ATTD 2025) - "Background and Aims A 43-year-old refugee woman with poorly controlled T1D (since 1988; June 2022 - HbA1c 11%) on a basal-bolus insulin regiment (glargine 22 IU + glulisine 16-12-16 IU) was admitted to a diabetes outpatients clinic in Slovenia...However, she irregularly administers 2-3 IU around 3:00 am.Results Average time in range (TIR) ​​on CGMS was 75.2% (71 – 83%). TIR on IP increased from an initial 52% to an average of 88.3% over the last 3 months, with a best period TIR of 92%, with no hypoglycemia.Conclusions IP with AHCLS and empirical modification of insulin boluses helps to improve glycemia in peritoneal dialysis with glucose solution."

Clinical • Metastases • Anemia • Diabetes • Diabetic Nephropathy • Diabetic Retinopathy • Hematological Disorders • Hypoglycemia • Metabolic Disorders • Renal Disease • Retinal Disorders • Type 1 Diabetes Mellitus

First Dimension Trap-and-Elute Combined with Second Dimension Reversed-Phase Liquid Chromatography Separation Using a Two-Dimensional-Liquid Chromatography-Tandem Mass Spectrometry System for Sensitive Quantification of Human Insulin and Six Insulin Analogs in Plasma: Improved Chromatographic Resolution and Stability Testing. (PubMed, J Sep Sci) - "Multidimensional chromatography coupled to tandem mass spectrometry (MS/MS), including simple sample preparation with protein precipitation, anion conversion with ammonium hydroxide, and solid-phase extraction using mixed-mode anion exchange in a 96-well plate format, has been validated for rapid simultaneous analysis of human insulin and its six analogs (lispro, glulisine, glargine, degludec, detemir, and aspart) in human plasma. Intra-run precision ranged from 1.1% to 5.7%, inter-run precision from 0.7% to 5.9%, and overall recovery from 96.9% to 114.3%. The validated method has been implemented successfully by the Department of Forensic Medicine at our hospital for the investigation of unexplained deaths."

Journal

BioJect: An in vitro platform to explore release dynamics of peptides in subcutaneous drug delivery. (PubMed, J Control Release) - "We systematically investigated the release mechanisms of four insulin formulations: regular human insulin, insulin aspart, insulin glulisine, and Neutral Protamine Hagedorn (NPH) insulin...The BioJect cell represents a significant advancement in simulating the SC environment for drug release testing. Our findings highlight the importance of considering protein binding and ECM components in predicting drug absorption, offering a promising tool for the development and optimization of SC formulations."

Journal • Preclinical

Jia Wei Qingxin Lotus Seed Drink ameliorates epithelial mesenchymal transition injury in diabetic kidney disease via inhibition of JMJD1C/SP1/ZEB1 signaling pathway. (PubMed, Phytomedicine) - "This study was the first to demonstrate that QISD might ameliorate DKD-EMT injury by inhibiting the JMJD1C/SP1/ZEB1 signaling pathway. These findings provide strong pharmacologic evidence for the clinical use of QISD in the treatment of DKD."

Journal • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Immunology • Metabolic Disorders • Nephrology • Renal Disease • CDH1 • SP1 • ZEB1

Safety Profiles Related to Dosing Errors of Rapid-Acting Insulin Analogs: A Comparative Analysis Using the EudraVigilance Database. (PubMed, Biomedicines) - "Although there were fewer dosing errors of RAIAs in comparison to other insulins, the severity of the potential outcome highlights the importance of precise dosing and timing. Improved the monitoring and reporting of these dosing errors could enhance diabetes patient care. Additionally, smart medical devices could improve therapeutic outcomes."

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

Optimization of a mass spectrometric analytical method for the quality assessment of insulin and its analogs. (PubMed, Pharmazie) - "In this study ESI-MS was used to assess the quality of human insulin, short acting insulin analogs, insulin lispro, insulin aspart and insulin glulisine and long acting analogs including insulin glargine, insulin degludec, and insulin detemir, in respective pharmaceutical formulations. The study results demonstrated that MS is a suitable technique for the analysis of biotechnological compounds like insulin and its analogs. Although the obtained results provide an important information regarding this methodology, further studies are needed to validate this analytical approach and check for its suitability to be used in the regulatory environment."

Journal

Therapy-Related Satisfaction and Quality of Life for Japanese People with Diabetes Using Rapid-Acting Insulin Analogs: A Web-Based Survey. (PubMed, Diabetes Ther) - "New RAIA users have greater treatment satisfaction than conventional RAIA users. QOL was similar among new and conventional RAIA users, except for satisfaction with treatment, which was significantly higher among new RAIA users. Detailed explanations from the doctor to the person with diabetes about the relationship between new RAIA and BG status are essential. A graphical plain language summary is available with this article."

HEOR • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Prandial Insulins: A Person-Centered Choice. (PubMed, Curr Diab Rep) - "In contrast, rapid-acting analogs, such as lispro, aspart, and glulisine, are new insulin types with amino acid modifications that enhance their subcutaneous absorption, resulting in a faster onset and shorter action duration. Ultra-rapid analogs, like faster aspart and ultra-rapid lispro, offer even shorter onset of action, providing better meal-time flexibility. The Technosphere insulin offers an inhaled route for prandial insulin delivery...Ongoing research is focused on refining prandial insulin replacement and exploring newer delivery methods. The article provides a comprehensive overview of various prandial insulin options and their clinical applications in the management of diabetes."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic-Euglycemic Clamp Procedure. (PubMed, Clin Pharmacol Drug Dev) - "The study results showed that the 90% CI for the geometric mean ratios of primary PK and PD of T-glu and reference insulin glulisine were within 80%-125% comparability limits, and that the safety profiles were comparable. PK, PD, and safety similarity of T-glu and reference insulin glulisine was demonstrated."

Clinical • Journal • PK/PD data

Biorelevant subcutaneous in vitro test predicts the release of human and fast acting insulin formulations. (PubMed, Int J Pharm) - "Significant differentiation was achieved at 90 % confidence level between the permeation curves of insulin glulisine containing formulations (U100 and a concentrated research formulation), while in case of the insulin lispro containing formulations (U100 and U200) the permeation curves showed similarity. These results demonstrated that the in vitro setup may be used as a tool for formulation development and drug candidate profiling as it is able to differentiate or show similarities between the agglomeration states and concentration of the active pharmaceutical ingredients."

Journal • Preclinical

NEWLY DIAGNOSED TYPE 2 DIABETES MELLITUS PRESENTING AS HYPERGLYCEMIC HEMIFACIAL SPASM (ICE-EDEC 2024) - "He was prescribed with carbamazepine, clonazepam and baclofen but with no relief...Patient was started on insulin glargine, insulin glulisine, metformin, and sitagliptin...He was sent home with insulin degludec/aspart, and metformin + sitagliptin. Hyperglycemia can manifest as various movement disorders, including chorea and seizures... Hyperglycemia can manifest as various movement disorders, including chorea and seizures. Hemifacial spasm is a rare presentation, distinct from the usual anatomical causes. The link to hyperglycemia might involve increased brain water content or impaired brain metabolism, impacting cerebral blood flow, notably the basal ganglia and neurotransmitter processing."

CNS Disorders • Diabetes • Epilepsy • Metabolic Disorders • Movement Disorders • Pain • Solid Tumor • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Active, not recruiting | Sponsor: Mannkind Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Sep 2024

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

TRICIDIA: Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes (clinicaltrials.gov) - P4 | N=14 | Terminated | Sponsor: Centre Hospitalier Universitaire Dijon | Unknown status ➔ Terminated | N=60 ➔ 14; recruitment difficulties

Enrollment change • Trial termination • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A prospective, multicentre, randomized, open-label comparison of a long-acting basal insulin analog glargine plus glulisine with premixed insulin in insulin naïve patients with Type 2 diabetes - A study from India. (PubMed, Prim Care Diabetes) - "Glargine plus Glulisine, though in higher dose was effective as premixed insulin in lowering HbA1c. Hypoglycemic events per person-year were similar in both groups."

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

Chromatographic-mass spectrometric analysis of peptidic analytes (2-10 kDa) in doping control urine samples. (PubMed, J Mass Spectrom) - "With urine samples representing still the most frequently collected doping control specimens, efficient extraction of peptidic analytes from this matrix was a major goal of this method, as demonstrated for the included compounds such as insulins (human, lispro, aspart, glulisine, tresiba, glargine metabolite, bovine insulin, porcine insulin), growth hormone-releasing hormones (sermorelin, CJC-1295, tesamorelin) incl. Nearly all requirements of the recent technical documents from the World Anti-Doping Agency (WADA) considering their minimum required performance levels (MRPL) are fulfilled, and the method was validated for its utilisation as initial testing procedure in doping controls. Finally, the approach was applied to authentic post-administration study urine samples (for insulins and gonadorelin) in order to provide proof of principle."

Journal • IGF1

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial completion date: Apr 2024 ➔ Apr 2025

Combination therapy • Trial completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal (clinicaltrials.gov) - P4 | N=72 | Completed | Sponsor: Medical University of Warsaw | Recruiting ➔ Completed | Trial completion date: Jan 2023 ➔ Apr 2023 | Trial primary completion date: Jul 2022 ➔ Jan 2023

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial primary completion date: Aug 2023 ➔ Dec 2023

Combination therapy • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Comparative study on the deamidation of three recombinant human insulins using capillary electrophoresis. (PubMed, J Chromatogr A) - "At +5 °C only 1-fold deamidation forms could be observed for each insulin. Acidified samples incubated for 1-month at room temperature showed varying levels of deamidation: 1-fold, 1-2-fold and 1-2-3-fold forms for glargine, glulisine and humulin, respectively."

Journal

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial primary completion date: Apr 2023 ➔ Aug 2023

Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus