The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Start Date26 Feb 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06178874

/ CompletedNot ApplicableIIT

Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

The role of ultralong insulin in the control of the blood glucose level in diabetic patients is well known, the current study will discuss the role of ultralong insulin in controlling of hyperglycaemia in critical illness defined as failure or impending failure of an organ

Start Date01 Dec 2023

Sponsor / Collaborator

Ain Shams University

NCT06153537

/ Enrolling by invitationNot Applicable

A Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control Associated With the Use of Dose Check App and Insulin Degludec in Patients With Type 2 Diabetes Mellitus in Saudi Arabia Under Real-world Setting

This study looks at how a mobile based app called 'Dose Check' used along with Tresiba helps to control blood sugar level in participants with type 2 diabetes mellitus. Participants will get Tresiba as prescribed by the study doctor or participants will continue already prescribed treatment with Tresiba. Participants will also be prescribed to use Dose Check app by the study doctor and will be asked to install the Dose Check app in their mobile phone, which will support participants with the correct dose of Tresiba. This study will last for about 6 to 7 months.

Start Date29 Nov 2023

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Insulin degludec

100 Translational Medicine associated with Insulin degludec

100 Patents (Medical) associated with Insulin degludec

907

Literatures (Medical) associated with Insulin degludec

01 Mar 2025·COMPUTERS IN BIOLOGY AND MEDICINE

Distribution-based sub-population selection (DSPS): A method for in-silico reproduction of clinical trials outcomes

Article

Author: Fabris, Chiara ; Ganji, Mohammadreza ; Breton, Marc ; Lv, Dayu ; El Fathi, Anas ; Kovatchev, Boris

Diabetes presents a significant challenge to healthcare due to the short- and long-term complications associated with poor blood sugar control. Computer simulation platforms have emerged as promising tools for advancing diabetes therapy by simulating patient responses to treatments in a virtual environment. The University of Virginia Virtual Lab (UVLab) is a new simulation platform engineered to mimic the metabolic behavior of individuals with type 2 diabetes (T2D) using a mathematical model of glucose homeostasis in T2D and a large population of 6062 virtual subjects. This work proposes a statistical method - the Distribution-based sub-population selection (DSPS) method - for selecting subsets of virtual subjects from this large initial pool, ensuring that the selected group possesses the desired characteristics necessary to reproduce and predict the outcomes of a clinical trial. DSPS formulates the sub-population selection as a linear programming problem, identifying the largest virtual cohort to closely resemble the statistical properties (moments) of key outcomes from real-world clinical trials. The method was applied to the insulin degludec arm of a 26-week phase 3 clinical trial, evaluating the efficacy and safety of insulin degludec and liraglutide combination therapy. DSPS selected a sub-population that mirrored clinical trial data across key metrics, including glycemic efficacy, insulin dosages, and cumulative hypoglycemia events, with a relative sum of square errors of 0.33 and a percentage error of 1.07 %. This approach bridges the gap between large population simulation platforms and clinical trials, enabling the selection of virtual sub-populations with specific properties required for targeted studies.

01 Mar 2025·Journal of diabetes science and technology

The Effect of Insulin Degludec Versus Insulin Glargine U100 on Glucose Metrics Recorded During Continuous Glucose Monitoring in People With Type 1 Diabetes and Recurrent Nocturnal Severe Hypoglycemia

Article

Author: Pedersen-Bjergaard, Ulrik ; Andersen, Henrik Ullits ; Beck-Nielsen, Henning ; Lerche, Susanne Søgaard ; Hansen, Troels Krarup ; Parving, Hans-Henrik ; Tarnow, Lise ; Gustenhoff, Peter ; Thorsteinsson, Birger ; Nørgaard, Kirsten ; Brøsen, Julie Maria Bøggild ; Alibegovic, Amra Ciric ; Juhl, Claus Bogh ; Stolberg, Charlotte Røn ; Agesen, Rikke Mette ; Jensen, Tonny Joran ; Hedetoft, Christoffer

Aim::

Comparing continuous glucose monitoring (CGM)-recorded metrics during treatment with insulin degludec (IDeg) versus insulin glargine U100 (IGlar-100) in people with type 1 diabetes (T1D) and recurrent nocturnal severe hypoglycemia.

Materials and methods::

This is a multicenter, two-year, randomized, crossover trial, including 149 adults with T1D and minimum one episode of nocturnal severe hypoglycemia within the last two years. Participants were randomized 1:1 to treatment with IDeg or IGlar-100 and given the option of six days of blinded CGM twice during each treatment. CGM traces were reviewed for the percentage of time-within-target glucose range (TIR), time-below-range (TBR), time-above-range (TAR), and coefficient of variation (CV).

Results::

Seventy-four participants were included in the analysis. Differences between treatments were greatest during the night (23:00-06:59). Treatment with IGlar-100 resulted in 54.0% vs 49.0% with IDeg TIR (70-180 mg/dL) (estimated treatment difference [ETD]: –4.6%, 95% confidence interval [CI]: –9.1, –0.0, P = .049). TBR was lower with IDeg at level 1 (54-69 mg/dL) (ETD: –1.7% [95% CI: –2.9, –0.5], P < .05) and level 2 (<54 mg/dL) (ETD: –1.3% [95% CI: –2.1, –0.5], P = .001). TAR was higher with IDeg compared with IGlar-100 at level 1 (181-250 mg/dL) (ETD: 4.0% [95% CI: 0.8, 7.3], P < .05) and level 2 (> 250 mg/dL) (ETD: 4.0% [95% CI: 0.8, 7.2], P < .05). The mean CV was lower with IDeg than that with IGlar-100 (ETD: –3.4% [95% CI: –5.6, –1.2], P < .05).

Conclusion::

For people with T1D suffering from recurrent nocturnal severe hypoglycemia, treatment with IDeg, compared with IGlar-100, results in a lower TBR and CV during the night at the expense of more TAR.

01 Mar 2025·DIABETES CARE

A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes

Article

OBJECTIVE:

To evaluate a regimen of inhaled Technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who prestudy were predominately using either an automated insulin delivery (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring.

RESEARCH DESIGN AND METHODS:

At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (N = 62) or usual care (UC) with continuation of prestudy insulin delivery method (N = 61) for 17 weeks.

RESULTS:

Prestudy, AID was used by 48% and MDI by 45%. Mean ± SD HbA1c was 7.57% ± 0.97% at baseline and 7.62% ± 1.06% at 17 weeks in the TI group and 7.59% ± 0.80% and 7.54% ± 0.77%, respectively, in the UC group (adjusted difference 0.11%, 95% CI −0.10 to 0.33, P value for noninferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5 mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5 mmol/mol) in 15 (26%) in the TI group and in 2 (3%) in the UC group. The most common TI side effect was a brief cough; eight participants discontinued TI due to side effects.

CONCLUSIONS:

In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was noninferior to UC, which consisted predominately of either AID or MDI. TI should be considered an option for people with type 1 diabetes, particularly those who are motivated to further reduce postprandial hyperglycemia.

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

External Link

KEGG	Wiki	ATC	Drug Bank
D09727	Insulin degludec	A10AE06	DB09564

R&D Status

Approved

10 top approved records.

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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
Cardiovascular Diseases	Phase 3	United States	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Japan	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Algeria	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Argentina	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Brazil	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Canada	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Croatia	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Greece	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	India	Novo Nordisk A/S	29 Oct 2013
Cardiovascular Diseases	Phase 3	Italy	Novo Nordisk A/S	29 Oct 2013

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)	bekorunrlw(gndohazszu) = mfizskvucs dmqjjjxxfm (tbudtcwyyi, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	bekorunrlw(gndohazszu) = whbjxttimu dmqjjjxxfm (tbudtcwyyi, 0.05) View more
NCT04538352 (TRANSITION-T2D, CTgov)	Phase 4	Diabetes Mellitus, Type 2	60	Insulin Degludec+semaglutide+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	gbaasrutef(wmfyteucfe) = ebznalrnlo uikdskywbe (nolnzgfwkn, nnomlzbcyz - kptvkrhjpw) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	gbaasrutef(wmfyteucfe) = nfgbrtwuao uikdskywbe (nolnzgfwkn, xkehsexqbf - kiltxxmtpj) View more
ADA2024 Manual	Not Applicable	Diabetes Mellitus, Type 2	159	fixed-ratio insulin degludec/liraglutide (Intervention regimen)	nmhqaybera(cqpeabjuuu) = pnuhhlzddz orcidkcmik (xhbuejgrft, 0.4) View more	Positive	21 Jun 2024
				Standard care	nmhqaybera(cqpeabjuuu) = vjhxaudgzw orcidkcmik (xhbuejgrft, 0.6) View more
ISN WCN2024	Not Applicable	Diabetes Mellitus, Type 2 \| Kidney Failure, Chronic	11	NPH insulin	oshkuxyoes(yoyatijrpw) = pvgnmzbjtg agtcvdgtog (hchshpfudz, ±76.9)	Positive	01 Apr 2024
				Glargine insulin	oshkuxyoes(yoyatijrpw) = bdilazfmiq agtcvdgtog (hchshpfudz, ±60.6)
NCT05434559 (Pubmed \| Diabetes Technol Ther) Manual	Not Applicable	Diabetes Mellitus, Type 1	486	Insulin degludec	cxjolenkcn(jllxryhxta) = fcixyjhxry ifdkwajbrp (temaiqyrnw ) View more	Positive	21 Mar 2024
				Other long-acting insulins	cxjolenkcn(jllxryhxta) = nmqaprylmf ifdkwajbrp (temaiqyrnw ) View more
EASD2023	Not Applicable	Diabetes Mellitus, Type 1	1,136	degludec (Young adults (aged 18-25))	czdilhubpa(bnxxuxigwq) = diqhsowgdc uerwyjkcxh (ezylijzbkd, 21.5% - 28.9%)	Positive	04 Oct 2023
				degludec (Injection time 9am-6pm)	czdilhubpa(bnxxuxigwq) = dikqxbwueg uerwyjkcxh (ezylijzbkd, 21.5% - 28.9%)
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	Phase 2	-	912	Once-weekly insulin efsitora alfa	spyftyevlq(eotkuytszy) = tlctlxhtvx xfritxyjsh (dmmwmoupjo ) View more	Positive	03 Oct 2023
				Once daily degludec	spyftyevlq(eotkuytszy) = psumgtlyyx xfritxyjsh (dmmwmoupjo ) View more
NCT03328845 (INEOX-Plus, ADA2023)	Phase 4	Diabetes Mellitus, Type 1	161	Insulin Degludec U100	vdgowkcgwk(rdvifybfgl) = pashofkbkn zgcdokcxyb (mdnhqytkyt )	-	23 Jun 2023
				Glargine U300	vdgowkcgwk(rdvifybfgl) = ymegelgslc zgcdokcxyb (mdnhqytkyt )
ADA2023	Not Applicable	Diabetic Ketoacidosis	255	iDeg	eclbxbtubv(lauiyctkzo) = gkjrsyurig xrrdrentbf (rldopsrjxr, 0.3 - 1) View more	-	20 Jun 2023
ADA2023	Not Applicable	-	-	Bridging dose of G with first dose of D	hbktfuhjff(qlminuxwbi) = hbzqszsoil grnwsyoewe (gmzpvhjgkv )	-	20 Jun 2023
				Placebo	bipsyqaapp(hgsjzuvuls) = twkfvjonmf jgbpotflez (yzgwsxibgx )

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