Delving into the Latest Updates on Insulin Degludec / Liraglutide with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

IDegLira, Insulin degludec/Liraglutide, Insulin degludec/Victoza

+ [11]

Target

GLP-1R x INSR

Action

agonists

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists), INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/SNovo Nordisk Canada, Inc.Novo Nordisk, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (18 Sep 2014),

Diabetes Mellitus, Type 2

Regulation-

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Structure/Sequence

Sequence Code 50953

The sequence is quoted from: *****

Sequence Code 4857

The sequence is quoted from: *****

Sequence Code 91440

The sequence is quoted from: *****

This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Participants will also be prescribed to use Dose Check app by study doctor. Participants will be asked to install the Dose Check app in their mobile phone, which will be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.

Start Date07 Nov 2024

Sponsor / Collaborator

Novo Nordisk A/S

ChiCTR2400086382

/ SuspendedPhase 4IIT

Safety and efficacy of GLP-1RA combined with Banxia Xiexin Decoction in the treatment of type 2 diabetes

Start Date15 Jul 2024

Sponsor / Collaborator-

NCT06408532

/ Not yet recruitingPhase 4IIT

The Evaluation of the Efficacy and Safety of Switching to Once-daily IDegLira in Patients With Type 2 Diabetes Receiving Premixed Insulin Therapy, a Multi-center, Randomized Control Trial

The study aims to evaluate the efficacy and safety of IDegLira in type 2 diabetes who have failed premixed insulin therapy. The study plans to enroll 256 participants with inadequate glycemic control despite twice-daily subcutaneous injections of premixed insulin and metformin. Participants will be randomly assigned to either the premixed insulin dose optimization group (control group) or IDegLira once daily group, and the difference in change in glycated hemoglobin levels from baseline to 16 weeks of treatment will be assessed between the two groups.

Start Date30 Apr 2024

Sponsor / Collaborator

Peking University People's Hospital

100 Clinical Results associated with Insulin Degludec / Liraglutide

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100 Translational Medicine associated with Insulin Degludec / Liraglutide

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100 Patents (Medical) associated with Insulin Degludec / Liraglutide

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145

Literatures (Medical) associated with Insulin Degludec / Liraglutide

01 May 2025·Value in Health Regional Issues

Cost-Effectiveness Analysis of Pharmacological Treatment With Insulin and Insulin Analogs for Type 1 and Type 2 Diabetes Mellitus in Colombia

Article

Author: Plazas, Merideidy ; Morales, Christian Camilo Anzola ; Arango, Luz Karime Osorio ; Escobar, Ivan Darío ; Ramirez, Luis Esteban Orozco ; Ibáñez, Diego Fernando Ávila

OBJECTIVESThis study aimed to estimate the cost-effectiveness relationship of insulins and insulin analogs in diabetes mellitus type 1 (DM1) and 2 (DM2), from the perspective of the Colombian health system.METHODSA short-term decision tree model (SM) was built, the outcome of which was severe/nocturnal hypoglycemia, and a long-term Markov model for quality-adjusted life-years. The probabilities were calculated through a literature review of effectiveness and safety. The costs are estimated from official databases. Deterministic and probabilistic sensitivity analyses were performed.RESULTSFor DM1, in prandial insulins, and for both models, the cost-effective interventions (CEIs) are aspartate and lispro. In basal insulins, the CEIs are NPH and glargine U-100 in both models. In the comparison of detemir and NPH, detemir generates lower nocturnal hypoglycemia and higher quality-adjusted life-years; however, in the long-term Markov model, the incremental cost-effectiveness ratio exceeds the threshold. For DM2, in the prandial insulin, and for both models, aspartate is a CEI and the glargine U-300 is also a CEI in the SM. In basal insulin, the CEIs are glargine U-100 and detemir (for nocturnal hypoglycemia) in both models and glargine U-300 is also a CEI in the SM. Finally, in the group of combinations, iGlarLixi is dominant over IDegLira.CONCLUSIONSThe results favor the use of analog insulins over human insulins, the former reducing the possibility of acute events and chronic complications to a greater extent.

01 May 2025·Diabetes Research and Clinical Practice

The impact of ideglira in treatment simplification in older adults with type 2 diabetes mellitus already on insulin therapy: The stop study

Article

Author: Mazzieri, Alessio ; De Fano, Michelantonio ; Boccardi, Virginia ; Mancinetti, Francesca ; Porcellati, Francesca ; Xenos, Dionysios ; Fanelli, Carmine G

AIMThe STOP study is a proof-of-concept, aimed at evaluating the effectiveness and safety of IdegLira in deintensifying diabetes therapy in elderly insulin-treated persons with T2DM.METHODSThe study was a real world, single center retrospective observation.RESULTS96 persons were enrolled (46F, age 77 ± 7 yrs, HbA1C 7.5 ± 1.0, diabetes duration 21 ± 10 yrs; 75 % in basal/bolus insulin therapy). After 6 months (T6), fasting plasma glucose significantly decreased as compared to T0, as did HbA_1C. The switch to IdegLira was associated with significantly lower rates of level 1 (L1) hypoglycemia at T3 (IR 0.24, 95 % CI 0.11-0.58, p < 0.001) and T6 (IR 0.08, 95 % CI 0.02-0.34, p < 0.001) as compared to T0. Level 2 (L2) hypoglycemia rates significantly decreased at T3 (IR 0.04, 95 % CI 0.01-0.32, p < 0.001) as compared to T0. The proportion of persons (incidence) with L1 hypoglycemia decreased from 33.7 % at T0 to 17.4 % at T3 (p = 0.004) and to 5.8 % at T6 (p < 0.001). Incidence of L2 hypoglycemia decreased from 22.1 % at T0 to 1.16 % at T3 (p < 0.001). No patients had L2 hypoglycemia at T6. Rapid acting insulin was interrupted in 85 % of patients.CONCLUSIONSIdegLira represents a viable option in deintensifying insulin therapy in an elderly population.

01 Aug 2024·Nutrition, Metabolism and Cardiovascular Diseases

Treatment intensification following glucagon-like peptide-1 receptor agonist in type 2 diabetes: Comparative effectiveness analyses between free vs. fixed combination of GLP-1 RA and basal insulin. RESTORE-G real-world study

Article

Author: Del Buono, Andrea ; Anichini, Roberto ; Cavalot, Franco ; Arca, Marcello ; Di Cianni, Graziano ; Morviducci, Lelio ; Fazion, Stefano ; Rossi, Maria Chiara ; Citro, Giuseppe ; Napoli, Raffaele ; Brandoni, Gabriele ; Porcellati, Francesca ; Terracciano, Annamaria ; De Riva, Carlo ; Candido, Riccardo ; Tortato, Elena ; Zenari, Luciano ; D'Angelo, Paola ; Nicolucci, Antonio ; Fiorentini, Paolo ; Rabini, Rosa Anna ; Lucibelli, Luigi ; Placentino, Giuseppe ; Gabellieri, Enrico ; Gregori, Giovanna ; Crazzolara, Dalia ; Aragiusto, Concetta ; Larosa, Monica ; Di Mauro, Maurizio ; Panzolato, Gianluigi ; Di Benedetto, Antonino ; Montani, Valeria

BACKGROUND AND AIMSAdd-on of basal insulin (BI) to intensify the ongoing therapy with glucagon-like peptide 1 receptor agonist (GLP-1 RA) is recommended, but it is unclear if free or fixed combination of BI and GLP-1 RA produce similar outcomes. A retrospective comparative effectiveness analysis of the add-on of glargine 300 U/mL (Gla-300) to ongoing GLP-1 RA vs. switch to fixed ratio combination of degludec and liraglutide (iDegLira) was performed.METHODS AND RESULTSReal-world data collected in electronic medical records by 32 Italian diabetes clinics. Propensity score (PS) adjustment was applied to assess changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), body weight, and BI dose after 6 months from Gla-300 or iDegLira initiation. Compared to iDegLira group (N = 260), Gla-300+GLP-1 RA group (N = 255) had older age and higher levels of HbA1c (9.1 vs. 8.9%). After 6 months, statistically significant greater FBG improvement [estimated mean difference and 95% confidence intervals: -24.05 mg/dl (-37.04; -11.06; p = 0.0003) and BI dose increase [+0.03 U/kg (95%CI 0.00; 0.06); p = 0.009] were found in the free vs. fixed combination group, although low doses of BI (0.2 U/kg) were reached in both groups. Trends of larger HbA1c and body weight reductions with the free combination were also found, without reaching the statistical significance.CONCLUSIONAlthough inertia in insulin initiation and titration was documented in both groups, higher benefit on FBG control was obtained with free vs. fixed combination, likely due to a better titration of BI and GLP-1 RA.

8

News (Medical) associated with Insulin Degludec / Liraglutide

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

12 Apr 2024

·firstwordpharma.com

EU probe finds no added suicide risk linked to GLP-1 agonists

The European Medicines Agency (EMA) announced on Friday that it found no added risk of suicidal and self-injurious thoughts associated with GLP-1 receptor agonists, including the ones sold by Novo Nordisk and Eli Lilly."After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies," the EMA said that "no update to the product information is warranted." The drugmakers will continue to monitor these events as part of their pharmacovigilance activities and "report any new evidence on this issue."The review started last July after it was reported that some patients using liraglutide and semaglutide experienced thoughts of suicide or self-injury. (For more, see Spotlight On: Heavy burden of obesity likely a factor in suicidal ideation signals, experts say). In November, the EMA widened its investigation, requesting additional data from the makers of Ozempic (semaglutide), Wegovy (semaglutide), Rybelsus (semaglutide), Victoza (liraglutide), Saxenda (liraglutide), Xultophy (degludec/liraglutide), Byetta (exenatide), Bydureon (exenatide), Lyxumia (lixisenatide), Suliqua (glargine/lixisenatid), and Trulicity (dulaglutide).Additionally, the EMA said it analysed the results of an electronic health records study, published in Nature Medicine in January, which investigated the incidence of suicidal thoughts in nearly 241,000 patients with overweight and type 2 diabetes treated with semaglutide or other non-GLP-1 receptor agonists. The study found no causal association between the use of semaglutide and suicidal thoughts. Another recent electronic health records study, conducted by EMA, did not support a causal association between the use of GLP-1 receptor agonists and this risk of suicide-related and self-injury-related events in people with type 2 diabetes.In January, a preliminary FDA report found no link between GLP-1 receptor agonists and suicidal thoughts or actions.

Drug ApprovalClinical Result

04 Dec 2023

·www.biospace.com

EMA Requests More Data from GLP-1 Drugmakers in Suicidal Ideation, Self-Harm Probe

Niels Wenstedt/BSR Agency/Getty Images The European Medicines Agency is asking the marketing authorization holders for several GLP-1 drugs for “further clarifications” as part of its ongoing review of the potential risk of suicide and self-harm thoughts, the EU watchdog announced on Friday. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said it had reviewed clinical trials, post-marketing surveillance and published literature on the reported cases of self-harm and suicidal thoughts. While the statement noted that “no conclusion can be drawn” on any causal association of these thoughts and GLP-1s, the PRAC emphasized that “several issues” still need to be clarified. The committee said the marketing authorization holders of multiple GLP-1s must address further lists of questions. The drugs named by the committee for the query include: Novo Nordisk’s Ozempic, Rybelsus, Saxenda, Xultophy, Victoza, Wegovy and Victoza, as well as Eli Lilly’s Trulicity and Byetta, AstraZeneca’s Bydureon, and Sanofi’s Lyxumia and Suliqua. Saxenda’s label has a warning for “suicidal behavior and ideation.” The PRAC plans to rediscuss the topic at a meeting in April 2024 and the EMA will provide more information when it becomes available. The EMA’s GLP-1 probe for possible risks of suicidal ideation and self-harm thoughts has been ongoing since July2023. That same month, the agency extended its review of potential risks for Ozempic and Saxenda to other GLP-1s. The initial review was triggered by the Icelandic Medicines Agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide.. At the time, the EMA said it was analyzing around 150 reports of cases of suicidal and self-harm thoughts. Soon after the EMA launched its review, the UK also initiated its own investigation. In late July 2023, the U.K.’s Medicine and Healthcare Product Regulatory Agency said it had received five reports of adverse reactions, including self-injury and suicidal behaviors for patients on semaglutide. Another 12 reports of self-harm and suicidal thoughts were recorded for liraglutide patients. However, thoughts of suicide or self-harm are not the only potentially adverse effects of the blockbuster drugs. In October 2023, a study published in the medical journal JAMA reported a risk associated with gastrointestinal adverse effects and GLP-1s. A Louisiana woman is also suing Novo Nordisk and Eli Lilly, alleging that both companies failed to warn its users about the risk of gastrointestinal issues for Mounjaro and Ozempic—including risks for gastroparesis and gastroenteritis. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

100 Deals associated with Insulin Degludec / Liraglutide

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Iceland	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	Norway	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	European Union	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	Liechtenstein	Novo Nordisk A/S	18 Sep 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	Australia	Novo Nordisk A/S	29 Aug 2012
Diabetes Mellitus, Type 2	Phase 2	Puerto Rico	Novo Nordisk A/S	29 Aug 2012
Diabetes Mellitus, Type 2	Phase 2	Turkey	Novo Nordisk A/S	29 Aug 2012
Diabetes Mellitus, Type 2	Phase 2	India	Novo Nordisk A/S	29 Aug 2012
Diabetes Mellitus, Type 2	Phase 2	Israel	Novo Nordisk A/S	29 Aug 2012
Diabetes Mellitus	Phase 2	Germany	Novo Nordisk A/S	01 Sep 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05324462 (SPIRIT, Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 2	175	IDegLira	ogwfxtdpkf(ispipilgrt) = pveyurilnp baagyqohjv (esihmgsrzr, - 1.6 - - 1.0) View more	Positive	08 May 2024
STOP study (EASD2023)	Not Applicable	Diabetes Mellitus, Type 2	93	IDegLira	(sadexdjskp) = urkujssyvy xaohuomiiw (dyricccrth ) View more	Positive	05 Oct 2023
NCT03737240 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	145	IDegLira (IDegLira)	zwlxyneadr(fikdjymuut) = avuffwdajc gjxwsgsfvr (yzossrsgdg, otrjgaotmu - qqfmbzvifn) View more	-	08 Sep 2023
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	zwlxyneadr(fikdjymuut) = qojjwgttxj gjxwsgsfvr (yzossrsgdg, nidxkefwdc - tjkrxnnokh) View more
EASD2022	Not Applicable	Diabetes Mellitus, Type 2 HbA1c \| c-peptide	73	Human BBT	qyskxektyb(ldhgpagbbu) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia jsseozpvjq (lbkdlnalqa )	Positive	20 Sep 2022
				IDegLira
IDegLira-HIGH Trial (ADA2022)	Not Applicable	Diabetes Mellitus, Type 2	-	IDegLira	(ufeadezwrh) = swjruvxnml zfgtbwxpbj (ssariwftgo ) View more	Positive	01 Jun 2022
				Basal Bolus	(ufeadezwrh) = ufxmnpbkqh zfgtbwxpbj (ssariwftgo ) View more
NCT03175120 (DUAL II China, EASD2020)	Phase 3	Diabetes Mellitus, Type 2	453	IDegLira	(gcsqfpovrm): P-Value = <0.0001 View more	Positive	23 Sep 2020
				Insulin degludec
NCT03172494 (DUAL I China, EASD2020)	Phase 3	Diabetes Mellitus, Type 2	720	IDegLira	(agiufpopas): ETD = -0.59 (95% CI, -0.73 to -0.46) View more	Positive	23 Sep 2020
				IDeg
NCT03172494 (DUAL I China \| DUAL™ I China, CTgov)	Phase 3	Diabetes Mellitus, Type 2	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	(mezpwhxzpw) = apmtmlnswp ewvgslwgwu (kqkpcdzfui, xjgchpklii - upsrvhvtxd) View more	-	07 Jul 2020
				Insulin degludec (Insulin Degludec)	(mezpwhxzpw) = hprzgrokqj ewvgslwgwu (kqkpcdzfui, fwpyktuuip - ngwvojpzjr) View more
NCT03175120 (DUAL™ II China \| DUAL II China, CTgov)	Phase 3	Diabetes Mellitus, Type 2	453	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	(ubphnalpqz) = qfwsdkxoxc nwvyqasbaq (kggecnzjhv, ejkimillys - uifnkmbkcv) View more	-	19 Mar 2020
				Insulin degludec (Insulin Degludec)	(ubphnalpqz) = ukdvwwwqhv nwvyqasbaq (kggecnzjhv, zaodbzhjrs - hkpdyvdbda) View more
NCT02420262 \| NCT01952145 (Pubmed \| Diabet Med)	Phase 3	Diabetes Mellitus, Type 2	-	Insulin degludec/liraglutide (IDegLira)	(wtwlexmter) = gzwmxxawfd hgmepdsesj (weonytixvy ) View more	-	01 Feb 2020

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