The SPEED study is a randomized, crossover pilot study evaluating the pharmacokinetics of novel insulin formulations in adults with type 1 diabetes. The study compares two experimental insulin formulations (diluted U-200 Humalog and U-500 Humulin with sterile water, mannitol and EDTA) against commercially available U-100 Lyumjev to determine if these modifications can improve insulin onset and duration of action.
Twenty participants will complete three study visits, each separated by at least48 hours. At each visit, participants will receive one of the three insulin formulations (0.20 u/kg) via subcutaneous injection following consumption of a standardized mixed meal. Blood samples will be collected frequently over 6 hours to measure insulin concentrations and assess pharmacokinetic parameters, including time to maximum concentration (Tmax), maximum concentration (Cmax), elimination half-life, and area under the curve.
The study aims to address limitations of current insulin formulations used in automated insulin delivery systems, which are too slow to provide optimal meal coverage without pre-meal dosing. By reducing zinc content through EDTA chelation and decreasing metacresol concentration through dilution, these novel formulations may offer faster onset and shorter duration of action, potentially improving glucose control in people with type 1 diabetes using insulin pump therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Stanford University

NCT07109245

/ Not yet recruitingPhase 4IIT

Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?

This study aimed at helping researchers understand how a medication called haloperidol can affect insulin action in the brain. Insulin is a hormone in the body that controls sugar levels in part by lowering the amount of glucose produced by the liver. After eating a meal, insulin levels go up in both the blood and the brain. Insulin in the brain has also been shown to affect the way the brain works and processes information (also known as "cognition"). Haloperidol, is an antipsychotic medication used to treat a variety of disorders such as schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, but long-term use can have metabolic side effects, like weight gain, type 2 diabetes, and cardiovascular disease. The purpose of this study is to investigate how antipsychotic medications, such as haloperidol, which carries the risk of metabolic changes, might interrupt the effect of insulin action in the brain. This will help researchers learn how to potentially reduce metabolic risk for people who take these kinds of medications in the future.

Start Date01 Sep 2025

Sponsor / Collaborator

Centre for Addiction & Mental Health

[+1]

NCT06945406

/ RecruitingPhase 1

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes

The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.

Start Date16 May 2025

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Insulin lispro

100 Translational Medicine associated with Insulin lispro

100 Patents (Medical) associated with Insulin lispro

1,310

Literatures (Medical) associated with Insulin lispro

01 Aug 2025·JOURNAL OF CLINICAL PHARMACOLOGY

Comparing the Efficacy of Various Insulin Types: Pharmacokinetic and Pharmacodynamic Modeling of Glucose Clamp Effects in Healthy Volunteers

Article

Author: Chang, Yi Chien ; Jusko, William J.

Abstract:

This study compares the pharmacokinetics and efficacy of various subcutaneously (SC) dosed insulin analogs, including rapid‐acting, intermediate‐acting, long‐acting, and regular human insulin, using mechanistic pharmacokinetic (PK) and pharmacodynamic (PD) models. These models were applied to data from euglycemic clamp studies in healthy volunteers, where insulin pharmacokinetics and its effects on glucose utilization were monitored. Data from published studies were digitized and modeled using MONOLIX (Version 2024). The PK model described insulin absorption via sequential first‐order processes and linear elimination. The PD effects were captured using a model combination of biophase, indirect, and receptor down‐regulation components. While PK parameters—especially absorption rates—varied between insulin types, a common set of nonlinear PD parameters was sought to account for dose‐related differences in glucose utilization. The maximum glucose stimulation () was 163, and the insulin concentration for a half‐maximal effect () were 1156 pmol/L for insulin lispro, regular human insulin, neutral protamine hagedorn (NPH) insulin, and insulin glargine; 674 pmol/L for insulin aspart; and 5335 pmol/L for insulin detemir. Insulin detemir showed similar overt effects as the other insulin types but with smaller clearances and lower potency. This mechanism‐based glucose–insulin model demonstrated that most insulin analogs exhibit similar receptor‐ and transporter‐related parameters. The model, with specific PK but unified PD parameters, may enable clinical optimization of insulin therapy by highlighting differences in pharmacokinetics and operating common intrinsic glucose utilization parameters.

01 Aug 2025·PROTEIN JOURNAL

High-Yield Biosynthesis Process for Producing Insulin Lispro

Article

Author: Luo, Jihong ; Liu, Shusheng ; Luo, Hua ; Chen, Xinan ; Chen, Junlin ; Wu, Wen ; Pei, Shuchen

Insulin lispro, a fast-acting insulin analogue, is widely used for the treatment of diabetes due to its rapid onset and high flexibility. This study established a three-step chromatography purification process, L fermentation broth can obtain 475 mg/L insulin lispro. Through a multi-step process involving fermentation, recovery of inclusion bodies, renaturation, enzymatic digestion, and chromatographic purification, a high-purity insulin lispro product was obtained. The final product achieved a purity of 99.7%. The high molecular weight protein was ≤ 0.1%, zinc content was 0.41%, host cell protein contamination was 2.31 ng/mg, and residual DNA was 1.57 ng/mg. Analytical results, including retention time, molecular weight, and peptide mapping, were consistent with theoretical expectations and matched the control. This purification process provides a streamlined and cost-effective method for large-scale production of insulin lispro, supporting further development of recombinant insulin analogs and offering high-quality active pharmaceutical ingredients for pharmaceutical formulations.

01 Jul 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information

Article

Author: Saino, Yuka ; Hariu, Aya ; Shinohara, Kayo ; Kuribayashi, Ryosuke

Information on biosimilars was rarely disseminated on the Pharmaceuticals and Medical Devices Agency (PMDA) website of the Japanese Regulatory Agency until the fiscal year (FY) 2022. Therefore, the PMDA website for biosimilars was created in FY 2023. This study confirmed the PMDA website for biosimilars and surveyed information about the approval fiscal year, brand name, indications at the initial approval, type of biopharmaceuticals, and disease area at the initial approval based on review reports and the "List of Approved Products." The PMDA website for biosimilars provides information on the definition of biosimilar, approved biosimilar products, related guidelines and notifications, learning videos, presentation material, and publication articles. As of March 2024, 35 biosimilars were approved in Japan based on the following 18 active pharmaceutical ingredients: somatropin, epoetin-alfa, filgrastim, infliximab, insulin glargine, rituximab, etanercept, trastuzumab, agalsidase beta, bevacizumab, teriparatide, darbepoetin-alfa, insulin lispro, adalimumab, insulin aspart, ranibizumab, pegfilgrastim, and ustekinumab. The disease area comprised nine patterns: rheumatology, oncology, hematology, gastroenterology, dermatology, endocrinology, ophthalmology, bone, and inborn errors represented in numbers and percentages for each pattern: 12 (23.1%), 9 (17.3%), 8 (15.4%), 7 (13.5%), 7 (13.5%), 5 (9.6%), 2 (3.8%), 1 (1.9%), and 1 (1.9%), respectively. This website provides various information regarding biosimilars in Japan. It will be more important to effort the understanding and education for the healthcare providers and patients on biosimilar regulations. Moreover, information should be disseminated through the PMDA website of biosimilars to accelerate and ensure transparency regarding regulatory approvals and biosimilar regulations.

News (Medical) associated with Insulin lispro

22 Jun 2025

·www.prnewswire.com

Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials

Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in The New England Journal of Medicine, while results from QWINT-3 and QWINT-4 were published in The Lancet. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.3 In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.4 In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.5 In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. "The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator for QWINT-1. "A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins." "Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. "These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world." Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, efsitora resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks. In QWINT-3, these rates were 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks. Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year. About the QWINT clinical trial program The QWINT Phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 3,000 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed dose escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. About insulin efsitora alfa Insulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. From a baseline of 8.20% for efsitora and 8.28% for insulin glargine. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. From a baseline of 7.80% for both efsitora and insulin degludec. From a baseline of 8.18% for both efsitora and insulin glargine. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia. Blood glucose <54 mg/dL. Nocturnal hypoglycemia was defined as any event that occurred at night between midnight and 6 a.m. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3

20 Jun 2025

·www.einpresswire.com

Diasome Pharmaceuticals Completes Enrollment in Phase 2b OPTI-2 Trial of HDV-Insulin Lispro for Type 1 Diabetes

Phase 2b OPTI-2 trial to assess liver-targeted insulin’s ability to reduce hypoglycemia and improve postprandial control using Dexcom G7 CGM data Reaching full enrollment is an important milestone for people who rely on insulin every day, and it is a significant step forward in the continued clinical development of HDV Insulin,” — Robert Geho, CEO CLEVELAND, OH, UNITED STATES, June 19, 2025 / EINPresswire.com / -- Diasome Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company advancing portal-hepatic targeted therapies for metabolic diseases, today announced that it has completed enrollment (n = 227) in its Phase 2b OPTI-2 trial evaluating HDV-Insulin Lispro in adults with Type 1 diabetes. OPTI-2 is a randomized, double-blind, active control study comparing Diasome’s Hepatocyte Directed Vesicle (HDV™) enabled insulin lispro to conventional lispro injected subcutaneously over a six-month treatment period. All study participants are utilizing Dexcom G7 continuous glucose monitors throughout the course of treatment to capture detailed glycemic endpoints. “Reaching full enrollment is an important milestone for people who rely on insulin every day, and it is a significant step forward in the continued clinical development of HDV Insulin,” said Robert Geho, Chief Executive Officer of Diasome. “OPTI-2 is designed to show that by directing insulin to the liver, where glucose regulation begins, we can meaningfully reduce hypoglycemia and improve post-meal glycemic control. We look forward to reporting topline data early in 2026.” OPTI-2 is designed to demonstrate that liver-targeted HDV-Insulin can widen the therapeutic window of mealtime insulin by reducing the risk of hypoglycemia while maintaining glycemic control. The trial is being conducted at 26 sites in the United States. About Diasome Pharmaceuticals Diasome Pharmaceuticals is developing HDV™—a proprietary phospholipid system that delivers native peptides, proteins, and hormones directly to the portal-hepatic axis, the body’s primary site of glucose and lipid regulation that current therapies often fail to reach. The company is advancing first-in-class therapies designed to enhance the efficacy, safety, and durability of treatment for diabetes, obesity, and related metabolic disorders. Media Related Inquiry Diasome Pharmaceuticals +1 216-444-7110 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2

18 Jun 2025

·www.einpresswire.com

Global Artificial Pancreas Devices Market is Gearing Up for Outstanding Expansion at a CAGR of ~16% by 2032 | DelveInsight

The global surge in diabetes cases is a key factor propelling the artificial pancreas device market, as a larger patient base fuels the need for effective diabetes management tools. Growing awareness and widespread screening initiatives have also contributed to earlier diagnoses and improved disease control, reinforcing the demand for advanced technologies such as artificial pancreas systems. Furthermore, ongoing product innovation and development by leading companies have led to more efficient and accessible devices, boosting market growth. New York, USA, June 18, 2025 (GLOBE NEWSWIRE) -- Global Artificial Pancreas Devices Market is Gearing Up for Outstanding Expansion at a CAGR of ~16% by 2032 | DelveInsight The global surge in diabetes cases is a key factor propelling the artificial pancreas device market, as a larger patient base fuels the need for effective diabetes management tools. Growing awareness and widespread screening initiatives have also contributed to earlier diagnoses and improved disease control, reinforcing the demand for advanced technologies such as artificial pancreas systems. Furthermore, ongoing product innovation and development by leading companies have led to more efficient and accessible devices, boosting market growth. DelveInsight’s Artificial Pancreas Devices Market Insights report provides the current and forecast market analysis, individual leading artificial pancreas devices companies’ market shares, challenges, artificial pancreas devices market drivers, barriers, trends, and key market artificial pancreas devices companies in the market. Key Takeaways from the Artificial Pancreas Devices Market Report As per DelveInsight estimates, North America is anticipated to dominate the global artificial pancreas devices market during the forecast period. In the device type segment of the artificial pancreas device market, the threshold-suspended device system had the highest revenue share in the year 2024. Notable artificial pancreas devices companies such as Medtronic PLC, Insulet Corporation, Tandem Diabetes Care, Inc., Beta Bionics, Inc., BIGFOOT BIOMEDICAL, INC., CamDiab Ltd., Diabeloop SA, Ypsomed, INREDA® DIABETIC B.V., Nikkiso Co., Ltd., Pancreum, Inc., Johnson & Johnson Services, Inc., Dexcom, Inc., TypeZero Technologies, Animas Corporation, and several others are currently operating in the artificial pancreas device market. In September 2024, Tandem Diabetes Care, Inc. , announced that its t:slim X2 insulin pump with Control-IQ automated insulin delivery (AID) technology was cleared for use with Eli Lilly and Company’s Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the European Union (EU). In June 2024, MCRA , a leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm, announced its role in assisting CamDiab's artificial pancreas software, CamAPS FX, in achieving U.S. Food and Drug Administration (FDA) clearance. To read more about the latest highlights related to the artificial pancreas devices market, get a snapshot of the key highlights entailed in the Global Artificial Pancreas Devices Market Report Artificial Pancreas Devices Overview Artificial pancreas devices represent a significant technological advancement in the management of type 1 diabetes, offering an automated solution to maintain optimal blood glucose levels. These systems typically combine a continuous glucose monitor (CGM), an insulin pump, and a sophisticated control algorithm that calculates and delivers insulin doses in real time. By mimicking some functions of a healthy pancreas, these devices help reduce the burden of frequent glucose monitoring and insulin administration, improving glycemic control and reducing the risk of both hyperglycemia and hypoglycemia. Recent innovations have led to the development of hybrid closed-loop systems, which require minimal patient intervention and can automatically adjust insulin delivery based on sensor readings. These devices have shown promising results in clinical trials and real-world settings, enhancing quality of life and long-term health outcomes for people with diabetes. Ongoing research is focused on improving algorithm accuracy, integrating dual hormone (insulin and glucagon) systems, and enhancing interoperability with smartphones and wearable technologies to create fully autonomous and user-friendly artificial pancreas solutions. Artificial Pancreas Devices Market Insights North America is projected to dominate the artificial pancreas device market in the coming years. This leadership can be attributed to several factors, including the growing prevalence of diabetes, increased government healthcare initiatives, the presence of major industry players engaged in strategic product innovations, and greater public awareness about diabetes management. Notably, rising awareness plays a significant role in driving demand for advanced diabetes care technologies such as artificial pancreas systems. For example, collaborative efforts by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) through programs like the National Diabetes Education Program (NDEP) aim to educate communities about continuous glucose monitoring and automated insulin delivery systems. Moreover, active product development and regulatory approvals continue to strengthen the market. A key milestone includes the FDA approval in May 2024 of the CamAPS FX artificial pancreas, developed by the University of Cambridge, for use in individuals with type 1 diabetes aged two years and above, including pregnant women. Collectively, these factors are expected to significantly fuel the growth of the artificial pancreas device market in North America throughout the 2025–2032 forecast period. To know more about why North America is leading the market growth in the artificial pancreas devices market, get a snapshot of the Artificial Pancreas Devices Market Outlook Artificial Pancreas Devices Market Dynamics The artificial pancreas devices market is witnessing strong growth driven by increasing global prevalence of type 1 diabetes and advancements in diabetes management technologies . As patient demand for convenient and accurate diabetes management tools rises, healthcare providers and manufacturers are increasingly focusing on developing integrated, closed-loop systems that mimic the glucose-regulating function of a healthy pancreas. Technological innovation is a core driver of the market, with developments in real-time glucose monitoring, machine learning algorithms, and smartphone integration enhancing the usability and precision of artificial pancreas systems. Companies are also leveraging cloud connectivity to enable remote patient monitoring and data sharing with healthcare providers. These advancements are improving both patient outcomes and physician decision-making while reducing the burden of disease management. The adoption of hybrid closed-loop systems , which allow partial automation, has paved the way for fully automated solutions, many of which are currently in advanced stages of clinical trials or have already gained regulatory approvals in key markets like the U.S. and Europe. Regulatory support and favorable reimbursement policies in several countries are also propelling market growth. Additionally, public and private payers are beginning to cover these systems, recognizing their long-term benefits in reducing diabetes-related complications and hospitalizations. However, in developing countries, market penetration remains limited due to high device costs and insufficient healthcare infrastructure. Despite these promising trends, the market faces notable challenges. High upfront costs of artificial pancreas systems , coupled with the need for regular maintenance and consumables , can deter widespread adoption, especially in low- and middle-income regions. Technical limitations, such as sensor calibration requirements, occasional device malfunction, and user training complexity , can also hinder patient acceptance and adherence. Furthermore, data security and privacy concerns regarding cloud-connected health devices must be carefully managed to maintain trust among users and healthcare providers. Looking ahead, the artificial pancreas market is poised for robust growth, supported by continuous innovation, strategic partnerships, and rising consumer awareness. Industry players are investing in R&D to enhance the accuracy, affordability, and user-friendliness of these systems. As the ecosystem evolves, integration with digital health platforms and expansion into emerging markets are expected to open new avenues for growth, ultimately moving closer to the vision of a fully automated, reliable, and accessible solution for diabetes management. Get a sneak peek at the artificial pancreas devices market dynamics @ Artificial Pancreas Devices Market Trends Report Metrics Details Coverage Global Study Period 2022–2032 Artificial Pancreas Devices Market CAGR ~16% Artificial Pancreas Devices Market Size by 2032 USD 1.1 Billion Key Artificial Pancreas Devices Companies Medtronic PLC, Insulet Corporation, Tandem Diabetes Care, Inc., Beta Bionics, Inc., BIGFOOT BIOMEDICAL, INC., CamDiab Ltd., Diabeloop SA, Ypsomed, INREDA® DIABETIC B.V., Nikkiso Co., Ltd., Pancreum, Inc., Johnson & Johnson Services, Inc., Dexcom, Inc., TypeZero Technologies, Animas Corporation, among others Artificial Pancreas Devices Market Assessment Artificial Pancreas Devices Market Segmentation Artificial Pancreas Devices Market Segmentation By Device Type: Threshold Suspended Device System and Non-Threshold Suspended Device System Artificial Pancreas Devices Market Segmentation By End User: Hospitals & Clinics, Homecare Settings, Ambulatory Surgical Centers, and Others Artificial Pancreas Devices Market Segmentation By Geography : North America, Europe, Asia-Pacific, and Rest of World Porter’s Five Forces Analysis, Product Profiles, Case Studies, KOL’s Views, Analyst’s View Which MedTech key players in the artificial pancreas devices market are set to emerge as the trendsetter explore @ Artificial Pancreas Devices Companies Table of Contents 1 Artificial Pancreas Devices Market Report Introduction 2 Artificial Pancreas Devices Market Executive Summary 3 Competitive Landscape 4 Regulatory Analysis 5 Artificial Pancreas Devices Market Key Factors Analysis 6 Artificial Pancreas Devices Market Porter’s Five Forces Analysis 7 Artificial Pancreas Devices Market Layout 8 Artificial Pancreas Devices Market Company and Product Profiles 9 KOL Views 10 Project Approach 11 About DelveInsight 12 Disclaimer & Contact Us Interested in knowing the artificial pancreas devices market by 2032? 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Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Landos Biopharma, Diamyd Medical, Gan&Lee Pharmaceuticals, Zealand Pharma, Kamada, AstraZeneca, Novo Nordisk, Provention Bio Preregistration, Histogen, Vertex Pharmaceuticals, Panbela Therapeutics, Arecor, Bioprojet, Novartis, ImCyse, Adocia, Anelixis Therapeutics, Tolerion, TikoMed, Avotres, REMD Biotherapeutics, Novo Nordisk, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 2 diabetes companies, including Eli Lilly and Company, Regor Pharmaceuticals Inc., AstraZeneca, Eccogene, Pfizer, Sciwind Biosciences USA Co., Ltd., MediciNova, Sparrow Pharmaceuticals, HighTide Biopharma Pty Ltd, Novo Nordisk A/S, Biomea Fusion Inc., among others. Type 2 Diabetes Pipeline Type 2 Diabetes Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key type 2 diabetes companies, including Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Rivus Pharmaceuticals, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical, among others. DelveInsight’s Pharma Competitive Intelligence Service : Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur info@delveinsight.com +14699457679 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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100 Deals associated with Insulin lispro

External Link

KEGG	Wiki	ATC	Drug Bank
D04477	Insulin lispro	A10AB04 A10AD04 A10AC04	DB00046

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	European Union	Eli Lilly Nederland BV	30 Apr 1996
Diabetes Mellitus	Iceland	Eli Lilly Nederland BV	30 Apr 1996
Diabetes Mellitus	Liechtenstein	Eli Lilly Nederland BV	30 Apr 1996
Diabetes Mellitus	Norway	Eli Lilly Nederland BV	30 Apr 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperglycemia	Phase 3	United States	Eli Lilly & Co.	01 Mar 2011
Diabetes Mellitus, Type 1	Phase 3	China	Eli Lilly & Co.	01 Mar 2005
Diabetes Mellitus, Type 2	Phase 3	Mexico	Eli Lilly & Co.	01 Nov 2002
Hyperinsulinemic Hypoglycemia, Familial, 7	Phase 1	Canada	Eli Lilly & Co.	14 Feb 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04200313 (Insulin-Only Bionic Pancreas Trial, CTgov)	Not Applicable	Diabetes Mellitus, Type 1	440	Usual Care (UC)	ufyydqpfdx(anduutzqcq) = sftqfjulsl qhtcmwbaoy (zixjvorsgb, 10.9) View more	-	07 Nov 2023
NCT04585776 (Pubmed \| Diabetes Ther)	Phase 2	Diabetes Mellitus, Type 1	31	Insulin degludec and Lispro	mrobuutspt(blscnpgqfv) = kgthimffjs ydndoyhikd (nayhatyhgd ) View more	Positive	01 Nov 2023
				Ultra rapid lispro (URLi)	kkgmdjwieu(fjolsdthkg) = sdprlzimwr rsyegyaavy (lwqdngzfmg ) View more
NCT05262387 (EASD2023)	Phase 1	Diabetes Mellitus, Type 1	-	Ultra rapid lispro (URLi)	xdeymxrtgh(bhkvblpcsu) = sslnijgufk qmeoepfcoq (tvtrcxbbgl )	Positive	03 Oct 2023
				Lispro	xdeymxrtgh(bhkvblpcsu) = wgecvqpfrh qmeoepfcoq (tvtrcxbbgl )
NCT04605991 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	176	Ultra rapid lispro (URLi)	usnhdpslsy(tgegphmcem) = uuppbxvzri foektpkgfr (galjqkbmxh ) View more	-	07 Apr 2023
NCT04605991 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	187	Insulin Glargine+LY900014	nomdsgccwd(pbthavqiws) = dcsztudbnn qixoxmnfvb (lbvlonoeaq, 1.38) View more	-	03 Mar 2023
NCT03952130 (CTgov)	Phase 3	Diabetes Mellitus, Type 1	354	insulin glargine+Insulin Degludec+Insulin Lispro (Insulin Lispro (Humalog))	znudrpsjmr(iajxyqihol) = hlhdxrtbhu uurkmjrdiq (zhoxqzabdu, 0.063) View more	-	08 Feb 2023
				Insulin Glargine+Insulin Degludec+LY900014 (LY900014)	znudrpsjmr(iajxyqihol) = gflywyftsy uurkmjrdiq (zhoxqzabdu, 0.064) View more
NCT03262116 (CTgov)	Phase 2/3	Diabetes Mellitus, Type 1	20	Insulin (Insulin-only Bionic Pancreas With BC222 Lispro)	qgqydtrjeg(fegkjkpsih) = fwcitschxq kiqhepuskg (htcyjjzwti, 9.2) View more	-	09 Dec 2022
				Insulin (Insulin-only Bionic Pancreas With Insulin Lispro)	qgqydtrjeg(fegkjkpsih) = oagburrqqu kiqhepuskg (htcyjjzwti, 13.1) View more
NCT03214380 (PRONTO-T2D, Pubmed)	Phase 3	Diabetes Mellitus, Type 2	933	Ultra-rapid lispro	nvritzzwpi(qhgnwcvvxr) = fqsjahwsto vhitdzxllw (oygjdqltpx )	Positive	04 Jul 2022
				Lispro (Humalog®)	nvritzzwpi(qhgnwcvvxr) = qwoakfyhcz vhitdzxllw (oygjdqltpx )

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