A Multi-centre, Prospective, Single-arm, Non-interventional Study Describing the Use of the Dose Check App in People Living With Type 2 Diabetes Mellitus and Treated With IDegLira in a Real-world Setting in Italy

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

100 Translational Medicine associated with Insulin Degludec / Liraglutide

100 Patents (Medical) associated with Insulin Degludec / Liraglutide

969

Literatures (Medical) associated with Insulin Degludec / Liraglutide

01 Dec 2025·Current Neurology and Neuroscience Reports

Special Considerations in the Treatment of Idiopathic Intracranial Hypertension

Review

Author: Friedman, Deborah I

PURPOSE OF REVIEW:

To review the management of Idiopathic Intracranial Hypertension (IIH) with co-existing conditions affecting therapy: obesity, sulfa allergy, nephrolithiasis, and pregnancy.

RECENT FINDINGS:

The IIH-WT trial showed that bariatric surgery is currently the most effective method for obese patients with IIH to lose weight, leading to normalization of CSF pressure in many cases. Allergy to sulfonamide antibiotics does not preclude the use of acetazolamide; rather, penicillin allergy or multiple drug allergies are the strongest predictor of a hypersensitivity reaction. Carbonic anhydrase inhibitors should be avoided in individuals with a personal history of nephrolithiasis; the risk of renal stones increases with concomitant use of other medications with the potential for nephrolithiasis. Glucagon-like peptide-1 receptor antagonists (GLP-1RA) are promising non-surgical weight loss options although preliminary studies have not demonstrated considerable impact on papilledema, headache or vision. Women with IIH have high rates of pregnancy complications partly related to obesity. Recommendations for weight gain or loss during gestation are controversial. Recent studies show better outcomes in obese women who maintain or lose weight while pregnant including gestational diabetes, pre-eclampsia and emergency caesarian section. Progress continues in the search for the cause and best treatments for IIH. Larger multicenter trials of GLP-1RA are needed to determine their efficacy.

01 Apr 2025·Journal of the American College of Emergency Physicians Open

A Case of Intussusception With Bowel Obstruction in a Gastric Roux-en-Y Patient Prescribed Semaglutide

Article

Author: Pavuluri, Suresh K ; Toumar, Ahmad ; Duffy, Andrew J

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are increasingly prescribed for glycemic control and weight loss management in type 2 diabetes. Their use, however, is associated with a wide range of gastrointestinal adverse effects like nausea, vomiting, and abdominal discomfort. This case report presents a 59-year-old woman with a previous Roux-en-Y gastric bypass who was prescribed semaglutide, and subsequently developed intussusception with small bowel obstruction and chemical pancreatitis. The patient presented to the emergency department with nausea, vomiting, and epigastric pain. The patient's laboratory and radiographic studies revealed a long segment of small bowel intussusception, resulting in a small bowel obstruction and likely chemical pancreatitis. Laparoscopic surgical intervention was required, ultimately converted to a laparotomy for successful reduction of the intussusception. This case report underscores a potential complication that may be seen in patients prescribed GLP-1RAs with prior gastric Roux-en-Y surgeries. The adverse effect is likely attributable to altered gastrointestinal motility and delayed gastric emptying, mechanisms that may be exacerbated by the combination of bariatric-induced anatomical changes and the pharmacological actions of GLP-1RAs. Given the increasing prevalence of GLP-1RA use, emergency medicine clinicians must remain vigilant for these potential serious adverse effects, particularly in patients with complex gastrointestinal histories to ensure timely diagnosis and intervention.

16 Mar 2025·POSTGRADUATE MEDICAL JOURNAL

Effects of new hypoglycemic drugs on patients with heart failure: a systematic review and network meta-analysis

Review

Author: Chen, Jun ; Song, Ruirui ; Gao, Hongmei ; Liu, Fang ; Sun, Songtao ; Shi, Xiaojing

Abstract:

Background:

Currently, there is no relevant study comparing sodium-dependent glucose transporter 2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), and dipeptidyl peptidase inhibitor (DPP4i) head to head to evaluate their comprehensive impact on heart failure patients.

Methods:

We conducted a comprehensive literature search across multiple databases. Utilizing the risk of bias tool from the Cochrane Collaboration, the methodological quality of included studies was critically assessed and potential publication bias was examined via funnel plots.

Results:

All results are presented as mean difference; 95% confidence interval (MD; 95% CI). The network meta-analysis indicated that in regards to left ventricular function, there is a big difference in the left ventricular ejection fraction (LVEF) of Empagliflozin 25 mg (13.64; 0.26, 27.01) compared to Canagliflozin 100 mg; and significant differences in the left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) of Dapagliflozin 10 mg (−0.76; −1.27, −0.25 and −0.95; −1.86, −0.05), Vildagliptin 50 mg (−1.05; −1.47, −0.63 and −1.12; −2.19, −0.05), and Sitagliptin 100 mg (−1.34; −2.31, −0.38 and −1.89; −3.50, −0.27) compared to Empagliflozin 10 mg. In terms of the quality of life, there are significant differences in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) and the Quality of life score of Sitagliptin 100 mg (408.08; 213.59, 602.57 and 3.74; 1.57, 5.92) compared to Dapagliflozin 5 mg. In terms of the cardiovascular outcome events, there is a significant difference in the heart failure rehospitalization rate of Dapagliflozin 10 mg (0.45; 0.25, 0.82) and Empagliflozin 10 mg (0.48; 0.28, 0.81) compared to Liraglutide 1.8 mg. Further significant differences are found in the all-cause mortality of Dapagliflozin 10 mg (0.81; 0.66, 0.98) compared to Vildagliptin 50 mg; the cardiovascular death of Albiglutide 30 mg (0.49; 0.28, 0.86) compared to Exenatide 2 mg; and the arrhythmic events of Liraglutide 1.8 mg (0.49; 0.26, 0.90) compared to Empagliflozin 10 mg. The network meta-analysis of SGLT2i, GLP-1RA, and DPP4i as a class of drugs showed that GLP-1RA is superior to SGLT2i in improving LVEF and reducing myocardial infarction/acute coronary syndrome, whereas DPP4i is superior to SGLT2i in improving LVEDV and LVESV.

Conclusions:

GLP-1RA is superior to SGLT2i in improving LVEF and reducing myocardial infarction/acute coronary syndrome, whereas DPP4i is superior to SGLT2i in improving LVEDV and LVESV.Key message What is already known on this topic—It has been confirmed that three new hypoglycemic drugs have a protective effect on the cardiovascular system. Studies have shown that sodium-dependent glucose transporter 2 inhibitors (SGLT2i) can improve cardiovascular outcomes and enhance the quality of life of heart failure patients. Currently, SGLT2i is widely used in the clinical treatment of heart failure, and related studies have shown that glucagon-like peptide-1 receptor agonists (GLP-1RA) and dipeptidyl peptidase inhibitor (DPP4i) also play important roles in the treatment of heart failure. What this study adds—However, there is no relevant research on whether these drugs’ clinical efficacy is dose-dependent. How this study might affect research, practice, or policy—This study included different doses of hypoglycemic drugs and used a network meta-analysis method to comprehensively evaluate the effects of three hypoglycemic drugs on heart function, quality of life, and prognosis in heart failure patients, providing a basis for clinical practice.

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 seeking additional information from the makers of GLP-1 drugs as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class. 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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE56	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	European Union	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	Iceland	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	Liechtenstein	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	Norway	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	Phase 1	Germany	Novo Nordisk A/S	01 Sep 2009

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	trobuticrm(cwsoganlpd) = jenbfpdmoi duhdpoxrul (jnumlvpphx, - 1.6 - - 1.0) View more	Positive	08 May 2024
NCT03737240 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	145	IDegLira (IDegLira)	gkoalwgvzf(wxgozkdfbw) = yrieuwqioj tbqmswhjep (ijhtxzpuzn, 2.29) View more	-	08 Sep 2023
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	gkoalwgvzf(wxgozkdfbw) = wmmenrogxc tbqmswhjep (ijhtxzpuzn, 1.79) View more
EASD2022	Not Applicable	Diabetes Mellitus, Type 2 HbA1c \| c-peptide	73	Human BBT	iaqqzvvhra(arltuyvats) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia xvtjloyvxs (ilcybyufno )	Positive	20 Sep 2022
				IDegLira
IDegLira-HIGH Trial (ADA2022)	Not Applicable	Diabetes Mellitus, Type 2	-	IDegLira	ppwvbdhijv(uwizqdxhdw) = vcivvslpsw evkdyfbaoo (exrdbkajsv ) View more	Positive	01 Jun 2022
				Basal Bolus	ppwvbdhijv(uwizqdxhdw) = oxrekeuodc evkdyfbaoo (exrdbkajsv ) View more
NCT03172494 (DUAL I China, EASD2020)	Phase 3	Diabetes Mellitus, Type 2	720	IDegLira	zedpmqietb(dslqcjtozp): ETD = -0.59 (95% CI, -0.73 to -0.46) View more	Positive	23 Sep 2020
				IDeg
NCT03175120 (DUAL II China, EASD2020)	Phase 3	Diabetes Mellitus, Type 2	453	IDegLira	ofydblelck(jiwrzmmbiu): P-Value = <0.0001 View more	Positive	23 Sep 2020
				Insulin degludec
NCT03172494 (DUAL I China \| DUAL™ I China, CTgov)	Phase 3	Diabetes Mellitus, Type 2	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	abltzvcndp(vgmtjxlfoz) = ornxzirxvd bfzwbltcxa (zvwjrpaiyw, 0.88) View more	-	07 Jul 2020
				Insulin degludec (Insulin Degludec)	abltzvcndp(vgmtjxlfoz) = ztbovohcig bfzwbltcxa (zvwjrpaiyw, 0.99) View more
NCT03175120 (DUAL™ II China \| DUAL II China, CTgov)	Phase 3	Diabetes Mellitus, Type 2	453	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	uruloecpmb(guryprxtxv) = aqcnucfolw lheugrgchq (oyiuatbdfi, 1.14) View more	-	19 Mar 2020
				Insulin degludec (Insulin Degludec)	uruloecpmb(guryprxtxv) = zrejlawjnu lheugrgchq (oyiuatbdfi, 1.19) View more
NCT02420262 \| NCT01952145 (Pubmed \| Diabet Med)	Phase 3	Diabetes Mellitus, Type 2	-	Insulin degludec/liraglutide (IDegLira)	wowtzvykvy(nhdkohfhvk) = vomngcpcyp ufkdxfwvqi (augkzszltn ) View more	-	01 Feb 2020
NCT02911948 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	210	metformin+degludec/liraglutide	owcvluhnlk(jjsoweoyqj): ETD = -13.98 (95% CI, -16.41 to -11.55), P-Value = <0.0001 View more	Superior	01 Dec 2019
				metformin+degludec

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