[Translation] A study comparing the pharmacokinetic profile of a single dose of IcoSema versus single doses of icodec insulin and semaglutide in Chinese subjects with type 2 diabetes

本研究将在2型糖尿病患者中比较作为固定比例复方制剂IcoSema或作为icodec胰岛素和司美格鲁肽单药给药时，icodec胰岛素和司美格鲁肽在血液中的水平。

[Translation]

This study will compare the blood levels of insulin icodec and semaglutide when they are given as a fixed-ratio combination, IcoSema, or as insulin icodec and semaglutide alone in people with type 2 diabetes.

Start Date22 Jun 2022

Sponsor / Collaborator

Novo Nordisk A/S

[+1]

NCT03922750

/ CompletedPhase 2

A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus

This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared. This is done to find the best way to switch to insulin 287. The participants will either get insulin 287 that they will have to inject once a week or insulin glargine that they will have to inject once a day. Which treatment any participant gets is decided by chance. The study will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the doctor will ask the participants to: 1) measure their blood sugar every day with a blood sugar meter using a finger prick; 2) write down different information in a diary daily and return this to their study doctor. 3) wear a medical device (sensor) that measures the participants blood sugar all the time for 18 weeks (about 4 months) during the study.

Start Date09 May 2019

Sponsor / Collaborator

Novo Nordisk A/S

NCT03951805

/ CompletedPhase 2

A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Insulin-naïve Subjects With Type 2 Diabetes Mellitus

This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes. Different ways of changing the dose of insulin 287 are also compared. This is done to find the best way to change the dose of insulin 287. Participants will either get insulin 287 that they will have to inject once a week or insulin glargine that participants will have to inject once a day. Which treatment participants get is decided by chance. The study will last for about 5 months (23 weeks). Participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the clinic visits participants will be asked not to eat or drink anything (except for water) in the last 8 hours before the visit. During the study, the study doctor will ask participants to:
measure blood sugar every day with a blood sugar meter using a finger prick.
write down different information in a diary daily and return this to the study doctor.
wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about 4 months) during the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

Start Date09 May 2019

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Long-acting basal insulin analogue(Novo Nordisk)

100 Translational Medicine associated with Long-acting basal insulin analogue(Novo Nordisk)

100 Patents (Medical) associated with Long-acting basal insulin analogue(Novo Nordisk)

Literatures (Medical) associated with Long-acting basal insulin analogue(Novo Nordisk)

01 Jan 2024·The Senior care pharmacist

Real-World Analysis of Long-Acting and NPH-Containing Insulins on Glycemic Control

Article

Author: Marcellus, Valerie ; Perez, Alexandra ; Hale, Genevieve ; Moreau, Cynthia ; Benny, Tina ; Rosario, Elaina

Introduction Affordability of insulin products has become a concern in the past several years as the average price of various insulin products has increased. While awaiting legislation at the federal level that would address issues leading to high insulin costs, providers may have shifted prescribing practices to prescribe the lowest-priced insulin products to achieve patients’ treatment goals. Objective To compare the prevalence of hypoglycemic events between patients receiving lower-cost neutral protamine Hagedorn (NPH)-containing human insulins and higher-cost long-acting insulin analogs in Medicare Part D enrollees within a management services organization, as well as assessing glycemic control and changes in body mass index. Methods This was a multicenter, retrospective study conducted at three primary care clinics. The co-primary outcomes were percent difference of documented mild and severe hypoglycemic events between individuals receiving NPH-containing human insulin and long-acting insulin. Results A total of 72 patients met inclusion criteria and were receiving NPH-containing human insulins or the long-acting insulin analogs, 15 and 57 patients, respectively. Severe hypoglycemic events occurred in 3.5% vs 0% of the long-acting insulin analog and NPH-containing human insulin group, respectively (P = 0.999). Mild hypoglycemic episodes were experienced by 31.6% versus 33.3% of long-acting insulin analog and NPH, respectively (P = 0.539). For secondary outcomes, no difference was observed in glycemic control outcomes across insulin groups. Conclusion Among Medicare Part D patients with type 2 diabetes mellitus, the use of NPH-containing human insulins was not associated with an increased risk of mild or severe hypoglycemia-related episodes or reduced glycemic control compared with long-acting insulin. Study findings suggest that lower-cost, NPH-containing human insulins may be an alternative to higher-cost, long-acting insulin analogs.

01 Aug 2023·Diabetes, obesity & metabolism

Long-acting insulin analogues and the risk of diabetic retinopathy among patients with type 2 diabetes: A population-based cohort study.

Article

Author: Platt, Robert W ; Yu, Oriana H Y ; Larose, Stéphanie ; Filion, Kristian B ; Filliter, Christopher

AIM:

To determine whether the use of long-acting insulin analogues is associated with an increased risk of incident diabetic retinopathy (DR) among patients with type 2 diabetes.

METHODS:

Using data from the Clinical Practice Research Datalink Aurum, this retrospective, population-based cohort study included patients with type 2 diabetes who initiated a long-acting insulin analogue (glargine, detemir, degludec) or Neutral Protamine Hagedorn (NPH) insulin. The primary outcome was incident DR. We used Cox proportional hazards models with inverse probability of treatment weighting to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for incident DR with insulin analogues versus NPH insulin.

RESULTS:

There were 66 280 new users of long-acting insulin analogues and 66 173 new users of NPH insulin. The incidence rate of DR was 101.7 per 1000 person-years (95% CI, 98.7-104.8) for insulin analogues and 93.2 (95% CI, 90.0-96.5) per 1000 person-years for NPH insulin. Compared with the current use of NPH insulin, insulin analogues were not associated with the risk of incident DR (HR 1.04, 95% CI, 0.99-1.09). The adjusted HRs were 0.84 (95% CI, 0.66-1.07) for proliferative DR and 1.02 (95% CI, 0.97-1.08) for non-proliferative DR.

CONCLUSIONS:

Compared with NPH insulin, long-acting insulin analogues were not associated with the risk of incident DR among patients with type 2 diabetes. This finding provides important reassurance regarding the safety of long-acting insulin analogues with respect to incident DR.

03 Jul 2022·Amyloid : the international journal of experimental and clinical investigation : the official journal of the International Society of Amyloidosis

A case of asymmetric insulin-derived localised amyloid deposition associated with long-acting insulin analog administration

Letter

Author: Morishita, Yoshiyuki ; Ookawara, Susumu ; Imamura, Shigeki ; Hirai, Keiji ; Hirai, Aizan ; Umemoto, Naoka ; Yazaki, Masahide ; Katoh, Nagaaki ; Oshiro, Hisashi ; Kametani, Fuyuki

News (Medical) associated with Long-acting basal insulin analogue(Novo Nordisk)

24 Jan 2025

·www.echemi.com

Breakthrough in Self-Developed Long-Acting Insulin Brings Hope to 900 Million Diabetics

On January 23, HengRui Pharma announced that the application for the marketing authorization of Shudi Insulin Injection (INS068) has been accepted by the National Medical Products Administration. This product marks the first self-developed long-acting insulin analogue in China. The marketing application is primarily based on positive results from two pivotal Phase III clinical trials (Studies 301 and 302). These trials assessed the efficacy and safety of Shudi insulin injection compared to glargine insulin in adults with type 2 diabetes mellitus (T2DM) who had poor glycemic control while on basal insulin or oral hypoglycemic agents. The 301 study enrolled 423 participants, while the 302 study included 513 participants. Both studies were successfully completed in December 2024. Results showed that after 26 weeks of treatment, Shudi insulin maintained a similar reduction in glycated hemoglobin (HbA1c) compared to glargine insulin, whether used alone or in conjunction with oral hypoglycemic agents. Moreover, the safety and tolerability profiles of Shudi insulin were favorable, with adverse events resembling those of glargine, and incidences of hypoglycemia, particularly nocturnal hypoglycemia, slightly lower than those observed with glargine. Both studies met their primary endpoints. Diabetes is a metabolic syndrome characterized by high blood sugar levels due to insulin secretion defects and/or inadequate insulin action. In 2021, the global population of diabetics reached 537 million, with approximately 140 million cases in China, making it the country with the highest number of diabetes patients. Projections indicate that by 2045, the global count may rise to 783 million, with China accounting for 170 million. T2DM constitutes over 90% of all cases, primarily resulting from insulin resistance and progressive decline in pancreatic β-cell function. If left uncontrolled or poorly managed, high blood sugar can lead to irreversible vascular complications, including retinopathy, renal failure, myocardial infarction, stroke, and amputation. The treatment of T2DM currently employs a comprehensive management model that includes dietary control, exercise, blood sugar monitoring, diabetes education, and pharmacotherapy. Lifestyle interventions serve as foundational treatment measures, and as T2DM progresses, it often necessitates a combination of different classes of hypoglycemic agents. Clinical guidelines recommend initiating insulin therapy when blood sugar levels remain uncontrolled after treatment with one or more oral agents. For newly diagnosed T2DM patients exhibiting significant hyperglycemic symptoms or ketosis, a short-term insulin intensification regimen is the preferred option. Shudi insulin injection is HengRui Pharma's self-developed long-acting insulin, characterized by its steady onset, prolonged duration of action, and lower risk of nighttime hypoglycemia. To date, approximately 34.88 million yuan has been allocated to the development of Shudi insulin-related projects. Globally, similar products have already received approval, including Novo Nordisk's Tresiba® and Sanofi's Toujeo®. According to the Nextpharma database, global sales of Tresiba® and Toujeo® combined reached $2.3 billion in 2023.

Phase 3Clinical ResultDrug Approval

08 Jan 2025

·www.prnewswire.com

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePhase 3Immunotherapy

23 May 2024

·www.biospace.com

FDA Flags Hypoglycemia Risk for Novo’s Once-Weekly Insulin Ahead of Adcomm

Pictured: Facade of Novo Nordisk’s office in Fremont, California iStock, hapabapa In advance of Friday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting, the FDA has raised concerns about hypoglycemia linked to Novo Nordisk’s insulin icodec, according to a briefing document. With an advisory committee meeting slated for Friday, the FDA has identified “excess hypoglycemia” associated with Novo Nordisk ’s insulin icodec, which the pharma is proposing as a once-weekly injection for diabetes mellitus. In its briefing document, the regulator’s reviewers flagged what they called a “significantly higher” rate of hypoglycemic episodes in type 1 diabetes (T1D) patients treated with insulin icodec, compared with insulin degludec. While hypoglycemia is an “expected adverse reaction” in patients who inject insulin, Novo’s once-weekly injection did not show “evidence of any additional glycemic control or other benefit” in T1D patients versus the active comparator, the FDA’s staffers wrote. “The patient-focused data … were inadequate to inform whether patients with T1D preferred the once-weekly basal insulin option to once-daily,” the FDA reviewers concluded. Novo is proposing insulin icodec to help glycemic control in patients with diabetes, but the panel of external experts will focus its discussions on the “benefits and risks of insulin icodec in patients with T1D.” Insulin icodec is a long-acting analog of insulin that hopes to differentiate itself from other once-daily insulin products on the market by offering a once-weekly dosing option. According to Novo’s briefing document for the adcomm meeting, insulin icodec contains a fatty acid side chain that allows it to bind to circulating albumin which in produces “a depot of essentially inactive insulin icodec,” from which the drug can be “slowly and continuously released.” To determine the effect of once-weekly insulin icodec on glycemic control, the Danish drugmaker ran the ONWARDS clinical development program, which consisted of six Phase III studies. Only one of these studies—ONWARDS 6—included patients with T1D. The trial demonstrated that Novo’s once-weekly injection was non-inferior to daily basal insulin in terms of glycemic improvement, but also found that treated patients had a higher risk of “clinically significant” or “severe” hypoglycemic episodes. Still, Novo maintains that the hypoglycemia risks “can be effectively managed by guidance” from physicians and that “the availability of a weekly insulin could provide an important and unique alternative treatment option for some people living with T1D.” According to the FDA’s briefing document, Novo has proposed to flag this hypoglycemia risk in insulin icodec’s label, guiding prescribers to limit its use to patients with continuous glucose monitoring devices and to those with low glycemic variability. The label will also recommend the discontinuation of insulin icodec in case of recurring hypoglycemia. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .

Phase 3Clinical Result

100 Deals associated with Long-acting basal insulin analogue(Novo Nordisk)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	United States	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 2	Phase 2	Canada	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 2	Phase 2	Czechia	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 2	Phase 2	Greece	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 2	Phase 2	Poland	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 2	Phase 2	Slovakia	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 2	Phase 2	Slovenia	Novo Nordisk A/S	29 Nov 2018
Diabetes Mellitus, Type 1	Phase 1	Germany	Novo Nordisk A/S	01 Oct 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03751657 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	247	Dipeptidyl peptidase-4 inhibitors+Insulin icodec+Metformin (Insulin 287)	jwhbvwltpg(hobrfobhrm) = dbemschfig niddlxsgge (yxqvxpxkof, 0.07) View more	-	01 Feb 2021
				Placebo (insulin 287)+Metformin (Insulin Glargine)	jwhbvwltpg(hobrfobhrm) = wzwwkdcbhe niddlxsgge (yxqvxpxkof, 0.07) View more
NCT03951805 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	205	Insulin (Insulin 287 (Titration Algorithm A))	lcgtbqrsoe(tmtehaodop) = oaprghlwza znwbjgxlvy (xvemthekpb, 1.81) View more	-	08 Jan 2021
				Insulin (Insulin 287 (Titration Algorithm B))	lcgtbqrsoe(tmtehaodop) = avvfnlbccq znwbjgxlvy (xvemthekpb, 1.80) View more
NCT03922750 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	154	Insulin icodec (Insulin 287 (Without Loading Dose))	njdvduvurb(hzldlhtrku) = mzmkitpxtj ycygezztaq (yfymkyzoxo, 2.34) View more	-	08 Jan 2021
				Insulin icodec (Insulin 287 (With 100% Loading Dose))	njdvduvurb(hzldlhtrku) = uopbnsoglp ycygezztaq (yfymkyzoxo, 2.13) View more
EASD2015	Not Applicable	Diabetes Mellitus, Type 2 HbA1c	-	basal insulin (Patients with uncontrolled T2D)	izdxpexonh(hsbpcclqqk) = aggzysnpri pysvsvraae (edrvswuupv )	Positive	16 Sep 2015
				basal insulin (Physicians)	izdxpexonh(hsbpcclqqk) = fgcawjvndy pysvsvraae (edrvswuupv )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Long-acting basal insulin analogue(Novo Nordisk)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation