Delving into the Latest Updates on Insulin degludec with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

IDeg, Insulin decludec, Insulin Degludec (Genetical Recombination)

+ [12]

Target

INSR

Action

agonists

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2Diabetes Mellitus

Inactive Indication

Diabetes Mellitus, Type 1Hypoglycemia

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk, Inc.

Novo Nordisk A/SNovo Nordisk Pharma Ltd.

+ [2]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (28 Sep 2012),

Diabetes Mellitus

Regulation-

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Structure/Sequence

Sequence Code 4857

Source: *****

Sequence Code 91440

Source: *****

A randomized open, positive parallel controlled clinical study design was adopted. Participants were randomly assigned 1:1 according to inclusion criteria and exclusion criteria into two treatment regiments: Delu insulin liraglupeptide injection group and premixed insulin (or premixed insulin analogue). After fasting blood glucose was controlled at 7.5mmol /l in the morning, blood glucose was monitored by CGM (14d), and the Time in Range (3.9-10 mmol/l) was compared. Glycated albumin was measured and stool samples were taken before treatment and at 4 weeks.

Start Date20 May 2024

Sponsor / Collaborator

Beijing Tsinghua Chang Gung Hospital

[+5]

100 Clinical Results associated with Insulin degludec

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100 Translational Medicine associated with Insulin degludec

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100 Patents (Medical) associated with Insulin degludec

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925

Literatures (Medical) associated with Insulin degludec

01 Jun 2025·DIABETES OBESITY & METABOLISM

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

Review

Author: Hafidh, Khadija ; Mehta, Roopa ; Faraoun, Khadra ; Li, Xuan‐Tony ; Anaforoğlu, İnan ; Home, Philip ; Lauand, Felipe ; Djaballah, Khier ; Serafini, Paul ; Pourrahmat, Mir‐Masoud

Abstract:

Aims:

To estimate the relative treatment effect of iGlarLixi (a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide) versus premixed insulin IDegAsp (insulin degludec plus insulin aspart) in people with type 2 diabetes (T2D) who advanced from basal insulin to iGlarLixi or IDegAsp in non‐Asian studies.

Materials and Methods:

Randomized controlled trials (RCTs) were identified in a systematic review by searching Embase (including congress abstracts from 2021 to 2023), MEDLINE® and CENTRAL on 10 October 2023. Treatment outcomes from non‐Asian RCTs for people with T2D previously treated with basal insulin, who switched to iGlarLixi or IDegAsp, were compared using a network meta‐analysis (NMA). Data analysis was performed using R, version 4.0.2.

Results:

The NMA included four RCTs (N = 2535). The results of the NMA showed that iGlarLixi (n = 810) was associated with a significantly greater reduction in HbA1c versus IDegAsp (n = 454) (mean difference [MD]: −0.39 [95% credible interval, CrI: −0.58, −0.21] %‐units). iGlarLixi was also associated with a significantly greater likelihood of achieving an HbA1c of <7.0% (risk ratio: 1.42, 95% CrI: 1.18, 1.71). A greater reduction in postprandial glucose was observed with iGlarLixi versus IDegAsp (MD: −1.38 [95% CrI: −2.15, −0.63] mmol/L). A body weight benefit that favoured iGlarLixi versus IDegAsp was documented (MD: −1.54 [95% CrI: −2.26, −0.84] kg). Hypoglycaemia evaluation was inconclusive due to definitional differences between trials.

Conclusions:

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.

01 Jun 2025·DIABETES OBESITY & METABOLISM

Time spent in glycaemic control with sustained body weight reduction with tirzepatide: A post hoc analysis of the SURPASS clinical trial programme

Article

Author: Thieu, Vivian T. ; Batterham, Rachel L. ; Liu, Minzhi ; Rosenstock, Julio ; Chen, Yanyun ; Bergman, Brandon K. ; Karanikas, Chrisanthi A. ; Garvey, W. Timothy ; Sharma, Palash

Abstract:

Aims:

This participant‐level exploratory analysis assessed the continuous time spent in glycaemic control and/or with sustained weight reductions with tirzepatide treatment in participants with type 2 diabetes (T2D) from the SURPASS programme.

Materials and Methods:

Participants (N = 6246) from SURPASS 1–5 were randomized to once weekly tirzepatide (5, 10 or 15 mg) or comparator (once weekly placebo, once weekly semaglutide 1 mg, insulin degludec or insulin glargine). Continuous time spent with HbA1c < 7.0% (53 mmol/mol), ≤6.5% (48 mmol/mol) and ≥5% body weight reduction and combined HbA1c ≤ 6.5% (48 mmol/mol) with a ≥5% body weight reduction were assessed through 40 weeks (SURPASS‐1, ‐2, and ‐5) or 52 weeks (SURPASS‐3 and ‐4). The non‐parametric Wilcoxon rank sum test was used to compare the median duration of continuous time spent in control, and logistic regression was used to analyse the proportion of participants achieving glycaemic control and body weight reduction at any time points or at the end of the primary study period.

Results:

Median time spent with HbA1c < 7.0% (53 mmol/mol) was 80% (tirzepatide) versus 70% (semaglutide) and 0% (placebo) of the treatment duration in 40‐week studies, and 77%–85% (tirzepatide) versus 62% (insulin degludec) and 23% (insulin glargine) of the treatment duration in 52‐week studies (p < 0.001). Time spent with HbA1c < 7.0% (53 mmol/mol) was generally similar across all tirzepatide doses in each study. Dose‐dependent increases in time spent with ≥5% body weight reduction were observed with tirzepatide (median time spent: 20%–77% with tirzepatide versus 25% with semaglutide 1 mg) (p < 0.001). Tirzepatide‐treated participants experienced longer time spent with HbA1c ≤ 6.5% (48 mmol/mol) and ≥5% body weight reduction versus semaglutide (median: 35%–60% vs. 7%) (p < 0.001).

Conclusions:

In this post hoc analysis, people with T2D experienced substantially longer continuous time in glycaemic control and more sustained body weight reductions with tirzepatide versus placebo and active comparators.

01 Jun 2025·ANNALS OF PHARMACOTHERAPY

Icodec: A Novel Once-Weekly Basal Insulin for Diabetes Management

Review

Author: Isaacs, Diana ; Goldman, Jennifer ; Triplitt, Curtis

Objective::

To evaluate the efficacy, safety, and clinical implications of insulin icodec, a novel once-weekly basal insulin for the treatment of type 1 diabetes (T1D) and type 2 diabetes (T2D), with an emphasis on its advantages and challenges in comparison with existing daily basal insulins.

Data Sources::

A literature search was performed using PubMed, Google Scholar, Embase, and ClinicalTrials.gov up to August 26, 2024, using the search terms icodec and ONWARDS trial . Studies involving patients living with T1D or T2D on once-weekly insulin icodec compared with once-daily insulins glargine U100, glargine U300, and degludec were considered for this review.

Study Selection and Data Extraction::

Relevant English-language studies and those conducted in humans were considered.

Data Synthesis::

Insulin icodec offers reduced dosing frequency and potentially superior glycemic management with a safety profile comparable to existing basal insulins.

Relevance to Patient Care and Clinical Practice::

Insulin icodec once-weekly dosing could significantly improve convenience and efficacy over daily basal insulins, representing a significant innovation in insulin therapy.

Conclusions::

Insulin icodec emerges as a promising option for diabetes management, potentially improving treatment adherence and quality of life.

82

News (Medical) associated with Insulin degludec

05 Mar 2025

·www.biospace.com

Novo, Sanofi Hit With Anti-Competitive Probe in South Africa:

iStock, valiantsin suprunovich The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices. The South African government is investigating alleged anti-competitive practices by Novo Nordisk and Sanofi in connection with human insulin pens, Bloomberg reported on Monday evening. The Competition Commission of South Africa, the government’s anti-trust agency, is scrutinizing the companies’ device patents and proprietary designs to determine if these are being exploited to limit competition and block the entry of other developers and suppliers, as per Bloomberg. The watchdog is currently in the process of coordinating with Novo Nordisk’s and Sanofi’s local entities. BioSpace has reached out to Sanofi and Novo Nordisk for their statements and will update this article accordingly. The insulin market has seen some heavy upheaval over the last few years, driven by key policy changes around the world. Chief among these is the Inflation Reduction Act, signed into law in August 2022, and the Affordable Insulin Now Act, both of which seek to dramatically minimize Americans’ out-of-pocket spending for insulins. Pressure from lawmakers have also helped lower insulin prices in the U.S. The Competition Commission’s investigation comes shortly after it fined Google about $30 million per year for the next five years, while also investigating Meta and the social media network X (formerly Twitter), all for business practices that harmed South African media. Eli Lilly in March 2023 announced that it would lower insulin prices by 70% and cap out-of-pocket costs at $35 per month. Novo and Sanofi followed suit soon after, enacting their respective price cuts in the subsequent weeks. Months later, however, Novo announced that it would discontinue its long-acting insulin product Levemir, removing both the vials and pen from the market by the end of 2024. Lilly in Mach 2024 announced that due to marketing constraints, availability of two of its inulin products—Humalog an Lispro— would be limited . Sanofi also discontinued its pre-mixed insulin product Insuman, though this move mostly affected the U.K. and came in February 2023, a month before it announced the insulin price cuts. In a May 2024 interview with BioSpace , BMO Capital Markets analyst Evan Seigerman said that Novo “can’t make a product they’re losing money on, which may be the case with some insulins, and at some point they need to be smart with capital.” Still, the drugmakers continue to innovate on insulins. Lilly, for instance, is advancing a once-weekly insulin injection, Phase III readouts for which showed it could lower A1C by 1.34% , as compared with the 1.26% reduction for once-daily insulin degludec. Novo is also working on its own once-weekly product, dubbed insulin icodec. In July 2024, however, the program hit a regulatory road bump when the FDA rejected its drug application, flagging issues with the use of the product in type 1 diabetes.

Phase 3

06 Feb 2025

·www.echemi.com

Novo Nordisk Reports 2024 Earnings with $42.13 Billion Revenue and Impressive Profit Margins

On February 5, Novo Nordisk officially released its annual report for 2024, revealing a remarkable revenue of 29.04 billion Danish kroner (approximately $42.13 billion), representing a 25% increase year-on-year. The operating profit also surged to 12.83 billion Danish kroner (around $18.62 billion), reflecting a 25% growth, while net profit reached 10.10 billion Danish kroner (about $14.65 billion), up 21%. Notably, Novo Nordisk's profit margin (operating profit/sales) stands at an impressive 44.19%, far surpassing many American pharmaceutical giants. Novo Nordisk operates primarily in two business segments: Diabetes and Obesity Care and Rare Diseases. The majority of its revenue comes from the Diabetes and Obesity Care segment, which generated 27.18 billion Danish kroner in sales for 2024, while the Rare Diseases segment contributed only 1.86 billion Danish kroner. The GLP-1 class of drugs has emerged as Novo Nordisk's biggest revenue driver. Rybelsus (oral semaglutide) achieved sales of 23.30 billion Danish kroner (approximately $3.38 billion), while Ozempic (injectable semaglutide) brought in 120.34 billion Danish kroner (around $17.46 billion). The weight-loss version, Wegovy, also performed well with sales of 58.21 billion Danish kroner (about $8.44 billion). The total sales for semaglutide reached $29.28 billion, showcasing its strong performance, although it has not yet dethroned Keytruda as the new king of drugs. In addition to semaglutide, Novo Nordisk's GLP-1 offerings include the previous generation liraglutide, with Victoza (liraglutide for diabetes) and Saxenda (liraglutide for weight loss) generating 5.48 billion Danish kroner (approximately $795 million) and 6.94 billion Danish kroner (around $1.01 billion), respectively. Insulin remains Novo Nordisk's second-largest revenue generator, with total sales of 55.37 billion Danish kroner (approximately $8.03 billion) in 2024, driven by the success of degludec insulin, which saw a 15.3% increase in sales compared to the previous year. The three long-acting insulins—Tresiba (degludec), Xultophy (degludec/liraglutide), and Levemir (detemir)—achieved sales of 9.91 billion, 4.67 billion, and 4.50 billion Danish kroner, respectively. The two premixed insulins, Ryzodeg (degludec/aspart) and NovoMix (premixed aspart), generated revenues of 4.93 billion and 5.86 billion Danish kroner, respectively, with the former showing growth while the latter declined. Rapid-acting insulins, including Fiasp (ultra-rapid aspart) and NovoRapid (aspart), collectively sold 18.52 billion Danish kroner, an increase of approximately 2.6 billion compared to the previous year. Additionally, Novo Nordisk continues to sell second-generation human insulin, which generated 6.97 billion Danish kroner, although this segment saw a year-on-year decline. In the Rare Diseases segment, Novo Nordisk's product pipeline primarily includes clotting factors and growth hormones, with total sales of only 1.86 billion Danish kroner, representing a small portion of overall revenue. Unlike other major international pharmaceutical companies, Novo Nordisk has not pursued large-scale acquisitions and maintains a research and development investment intensity of around 15%. However, the company's sustained high revenue growth demonstrates its efficiency in product development. This efficiency can be attributed to four key factors: a strong focus on diabetes, extensive knowledge accumulation over a century, a commitment to user experience, maximizing market value from existing products, and the development of platform technologies. With advanced fatty acid acylation technology, peptide oral delivery technology, and yeast fermentation technology, Novo Nordisk is well-positioned to maintain its competitive edge in the market.

AcquisitionFinancial StatementDrug ApprovalBiosimilar

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

100 Deals associated with Insulin degludec

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KEGG	Wiki	ATC	Drug Bank
D09727	Insulin degludec	A10AE06	DB09564

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	China	Novo Nordisk A/S	20 Sep 2017
Diabetes Mellitus	Japan	Novo Nordisk Pharma Ltd.	28 Sep 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	United States	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	France	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	Germany	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	Russia	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	South Africa	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	United Kingdom	Novo Nordisk A/S	01 Sep 2009
Hypoglycemia	Phase 1	Germany	Novo Nordisk A/S	01 Aug 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04795531 (ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	radynatvcb(dtxqjgvtnj) = equamilpfe vwthdhpnhv (pjpcywdbnp, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	radynatvcb(dtxqjgvtnj) = itlwmljfch vwthdhpnhv (pjpcywdbnp, 0.05) View more
NCT05243628 (ABC, CTgov)	Phase 4	Diabetes Mellitus, Type 1	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	rjucwlvuys(qsgjwdpcdw) = kwglvxevcu fhdiyytdbr (hjykrhbbva, 0.58) View more	-	18 Oct 2024
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	rjucwlvuys(qsgjwdpcdw) = zdrlnxdoqk fhdiyytdbr (hjykrhbbva, 0.29) View more
NCT04538352 (TRANSITION-T2D, CTgov)	Phase 4	Diabetes Mellitus, Type 2	60	Semaglutide+Insulin Degludec+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	uocowlagwp(eahlkuiiem) = oopviueioe fobxtpifmx (jdtomlogwh, rcmdyhytrh - tnmyycadro) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	uocowlagwp(eahlkuiiem) = vajstyinew fobxtpifmx (jdtomlogwh, iqmhrxwamo - kposvwmtzj) View more
ADA2024 Manual	Not Applicable	Diabetes Mellitus, Type 2	159	fixed-ratio insulin degludec/liraglutide (Intervention regimen)	srcsrvkasd(spyuwfyvye) = khvmzcbrbu koegwamxpl (zwfnipohni, 0.4) View more	Positive	21 Jun 2024
				Standard care	srcsrvkasd(spyuwfyvye) = zivtdlzxlb koegwamxpl (zwfnipohni, 0.6) View more
ISN WCN2024	Not Applicable	Diabetes Mellitus, Type 2 \| Kidney Failure, Chronic	11	NPH insulin	fqwgzioolv(oafhlvdekb) = urxqkbjriy skyzodspfv (vhryzrhtpe, ±76.9)	Positive	01 Apr 2024
				Glargine insulin	fqwgzioolv(oafhlvdekb) = yxpyrekaaj skyzodspfv (vhryzrhtpe, ±60.6)
NCT05434559 (Pubmed \| Diabetes Technol Ther) Manual	Not Applicable	Diabetes Mellitus, Type 1	486	Insulin degludec	iajxjynboy(lxvdvlpmuq) = skuumkcxzm wajwzjiaca (nierfyaysa ) View more	Positive	21 Mar 2024
				Other long-acting insulins	iajxjynboy(lxvdvlpmuq) = wxbbyxokef wajwzjiaca (nierfyaysa ) View more
EASD2023	Not Applicable	Diabetes Mellitus, Type 1	1,136	degludec (Young adults (aged 18-25))	ysumuatuyw(bmqrvbyqhr) = ueydgatnvr ebzfdwcjyd (opkmnlhsik, 21.5% - 28.9%)	Positive	04 Oct 2023
				degludec (Injection time 9am-6pm)	ysumuatuyw(bmqrvbyqhr) = iklzmqbder ebzfdwcjyd (opkmnlhsik, 21.5% - 28.9%)
NCT03882970 (SURPASS-3 MRI, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 BMI \| fatty liver index \| triglycerides ... View more	-	Tirzepatide 5 mg	bvjustmttd(intlsrfkcp) = ahgpwpajnx azvbfliyxc (hxzpdiiwmh, 0.74)	Positive	03 Oct 2023
				Tirzepatide 10 mg	bvjustmttd(intlsrfkcp) = drjrfufnoi azvbfliyxc (hxzpdiiwmh, 0.74)
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	Phase 2	-	912	Once-weekly insulin efsitora alfa	besgmhydxq(rtshuxohxg) = fxdjrcipfo ogzpfqjtfw (pnzjmrrrwr ) View more	Positive	03 Oct 2023
				Once daily degludec	besgmhydxq(rtshuxohxg) = pkjmnwwpqj ogzpfqjtfw (pnzjmrrrwr ) View more
NCT03328845 (INEOX-Plus, ADA2023)	Phase 4	Diabetes Mellitus, Type 1	161	Insulin Degludec U100	zqahvfqgqe(xpedaypwei) = rpuckoloew clqjeabaeu (wkkpsouuis )	-	23 Jun 2023
				Glargine U300	zqahvfqgqe(xpedaypwei) = irjmykyvze clqjeabaeu (wkkpsouuis )

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Insulin degludec

Overview

Basic Info

Structure/Sequence

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R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation