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 May 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06449703 / RecruitingPhase 1

A Randomized, Open-label, Two-period, Cross-over Trial to Evaluate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Injection Compared With Xultophy® in Healthy Chinese Subjects

The main purpose of the trial is to compare the pharmacokinetics of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared with Xultophy®. During the trial period, serials of blood samples will be collected from the participants at two dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.

Start Date06 May 2024

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

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

129

Literatures (Medical) associated with Insulin Degludec / Liraglutide

01 Jan 2024·Diabetes therapy : research, treatment and education of diabetes and related disorders

Use of IDegLira to Intensify, Simplify, and Increase Appropriateness of Type 2 Diabetes Therapy: A Real-Life Experience

Article

Author: Serra, Rosalia ; Romano, Isabella

INTRODUCTION:

Fixed ratio combination of insulin degludec and liraglutide (IDegLira) represents an option to revise inappropriate therapies in patients with poorly controlled type 2 diabetes. This study aimed to assess the pattern of use and 1-year effectiveness of IDegLira.

METHODS:

A retrospective chart review was performed to assess changes in glycated hemoglobin (HbA1c) (primary endpoint), fasting blood glucose (FBG), body weight, estimated glomerular filtration rate (eGFR), and lipid profile following IDegLira initiation. Previous versus concomitant diabetes treatments were also compared.

RESULTS:

Overall, 87 patients (mean age 73.9 ± 9.2 years, diabetes duration 18.2 ± 6.7 years, 62.1% men, HbA1c 8.3 ± 1.3%, BMI 30.4 ± 5.5 kg/m²) initiated IDegLira. Previously, 21.8% of patients were treated with oral hypoglycemic agents (OHA group), 47.1% with basal insulin ± OHA (BOT group), 5.8% with GLP-1 RA ± basal insulin (GLP1-RA group), and 25.3% with basal-bolus schemes (BB group). At the first prescription of IDegLira, secretagogues and schemes including two or more OHA were substantially reduced, leaving metformin as the most prevalent OHA (81.6%) used in combination with IDegLira. Starting dose of IDegLira ranged from 18.7 ± 3.1 U (OHA group) to 24.1 ± 4.4 U (BB group). After 1 year, HbA1c was significantly reduced by 1.25% (95% CI - 1.48; - 1.03), FBG by 52.9 mg/dl, and body weight by 2.0 kg. Also, eGFR levels and lipid profile significantly improved. No severe hypoglycemia occurred.

CONCLUSION:

It is possible to proactively review suboptimal or inappropriate diabetes treatment according to the most recent guidelines. Results suggest that initiation of IDegLira was associated with a reduction in drugs to be administered daily and relevant improvements in clinical outcomes.

01 Nov 2023·Diabetes therapy : research, treatment and education of diabetes and related disorders

Simplification of Complex Insulin Regimens with IdegLira in People with Type 2 Diabetes: Literature Review and Clinical Recommendations.

Article

Author: Ordóñez, J E ; Ramírez, A ; Builes-Montaño, C ; Wandurraga, E

INTRODUCTION:

This study developed a simple algorithm based on clinical results described in medical literature and which allows one to simplify complex insulin regimes with IdegLira to avoid adverse events related to the complexity of some insulin treatments.

METHODS:

We conducted a systematic review of the literature that allowed us to identify studies that evaluated the clinical result of simplifying complex insulin regimes. The authors reviewed the common factors these simpler regimes had, including the type of patients who used them.

RESULTS:

We found nine clinical studies published between 2017 and 2022, eight performed in Europe and one in Latin America. The monitoring time of the studies ranged between 3 and 18 months. The size of the study populations was between 61 and 611 patients (the latter was in five countries). In all studies, HbA1c decreased by 0.6-1.7% and the weight decreased by 0.1-3.11 kg.

CONCLUSIONS:

On the basis of the findings of these studies, we made some recommendations for clinical practice to simplify treatment. The results of these studies support an algorithm that simplifies the treatment of complex insulin regimens.

01 Oct 2023·EClinicalMedicine

Glucometabolic outcomes of GLP-1 receptor agonist-based therapies in patients with type 2 diabetes: a systematic review and network meta-analysis

Article

Author: Perrini, Sebastio ; Laviola, Luigi ; Caruso, Irene ; Palmer, Suetonia Cressida ; Strippoli, Giovanni F M ; Cignarelli, Angelo ; Giorgino, Francesco ; Natale, Patrizia ; Di Molfetta, Sergio ; Natalicchio, Annalisa ; Di Gioia, Ludovico

Background:

Innovative GLP-1 receptor agonist (GLP-1RA)-based treatment strategies-such as tirzepatide, GLP-1RA plus basal insulin fixed-ratio combinations [FRC], GLP-1RA plus sodium glucose cotransporter-2 inhibitors [SGLT-2i] combinations, and high-dose GLP-1RA-have been listed among the most efficacious options for type 2 diabetes management. However, differences in their glucometabolic effects have not been assessed in dedicated head-to-head trials. In the absence of such trials, we aimed to provide a useful comparison among these treatment strategies to guide clinical practice.

Methods:

In this network meta-analysis, we searched PubMed, MEDLINE, and Web of Science (from database inception to June 24, 2023) for randomised controlled studies, published in English, that enrolled individuals with type 2 diabetes treated with tirzepatide, iGlarLixi, iDegLira, GLP-1RA plus SGLT-2i combination, or high-dose GLP-1RA (dulaglutide 3 mg and 4.5 mg, semaglutide 2 mg) compared with placebo or active comparators. Eligible studies reported change from baseline in HbA1c as an outcome, which was the primary outcome of this analysis. Secondary outcomes were changes in fasting and post-prandial glucose, bodyweight, LDL-cholesterol, blood pressure and risk of hypoglycaemia. We assessed risk of bias through the Cochrane Collaboration's tool (RoB2 tool), publication bias through visual inspection of funnel plots and Egger's test, and heterogeneity by comparing the magnitude of the common between-study variance (τ²) for each outcome with empirical distributions of heterogeneity variances. This network meta-analysis was registered in PROSPERO (CRD42022329878).

Findings:

40 trials were included. Tirzepatide 15 mg ranked first in terms of HbA1c reduction compared to other GLP-1RA-based strategies, even those including insulin (vs. iDegLira MD -0.40%, 95% CI [-0.66; -0.14], low certainty; vs. iGlarLixi MD -0.48%, 95% CI [-0.75; -0.21], low certainty), without increasing the risk of hypoglycaemia (vs. iDegLira OR 0.35, 95% CI [0.16; 0.79], high certainty; vs. iGlarLixi OR 0.31, 95% CI [0.20; 0.48], high certainty). Tirzepatide 15 mg was also the most efficacious on weight lowering, even compared to high-dose GLP-1RA (eg, semaglutide 2 mg MD -6.56 kg, 95% CI [-7.38; -5.73], low certainty) and GLP-1RA plus SGLT-2i combination (MD -4.61 kg, 95% CI [-5.29; -3.93], low certainty). Risk of bias and publication bias were generally low throughout studies, while high levels of heterogeneity were detected for most outcomes.

Interpretation:

Aiming to support clinicians in tailoring treatment to patients' needs, we suggest that a hierarchy among treatment strategies be devised considering the best options for type 2 diabetes. Tirzepatide, followed by GLP-1RA plus basal insulin FRC and GLP-1RA plus SGLT-2i combination, was associated with greater benefit on HbA1c than high-dose GLP-1RA.

Funding:

Fondazione per la Ricerca Biomedica "Saverio e Isabella Cianciola" and Next Generation EU, in the context of the National Recovery and Resilience Plan, Investment PE8-Project Age-It: Ageing Well in an Ageing Society.

News (Medical) associated with Insulin Degludec / Liraglutide

27 Jun 2024

·www.drugs.com

Exercise + GLP-1 RA Effective for Weight Loss While Preserving BMD

THURSDAY, June 27, 2024 -- For adults with obesity, without diabetes, combining exercise with the glucagon-like peptide-1 receptor agonist (GLP-1 RA), liraglutide , is effective for weight loss, while preserving bone health, according to a study published online June 25 in JAMA Network Open . Simon Birk Kjær Jensen, Ph.D., from the University of Copenhagen in Denmark, and colleagues examined bone health at clinically relevant sites after diet-induced weight loss followed by a one-year intervention with exercise, liraglutide, or both in a secondary analysis of a randomized trial involving adults aged 18 to 65 years with obesity, without diabetes. After an eight-week low-calorie diet, participants were randomly allocated to exercise alone, the GLP-1 RA liraglutide alone, the combination, or placebo for 52 weeks (48, 49, 49 and 49 participants, respectively). The researchers found that the total estimated mean change in weight losses during the study was 7.03 kg in the placebo group and 11.19, 13.74, and 16.88 kg in the exercise, liraglutide, and combination groups, respectively. Bone mineral density (BMD) was unchanged in the combination group versus the placebo group at the hip and lumbar spine. BMD decreased for the liraglutide versus the exercise group at the hip and spine (mean changes, −0.013 and −0.016 g/cm 2 , respectively). "Our findings highlight the importance of combining exercise with GLP-1 RA treatment for bone health," the authors write. Novo Nordisk supplied the liraglutide and placebo pens; Cambridge Weight Plan supplied low-calorie meal replacement products. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

26 Jun 2024

·www.echemi.com

Novo Nordisk's Semaglutide - A Breakthrough in Obesity Management

Semaglutide, the active ingredient in Novo Nordisk's Wegovy®, is a GLP-1 receptor agonist that works by binding to and activating the GLP-1 receptor, thereby exerting its effects in the treatment of obesity. Given that the GLP-1 receptor is involved in the specific brain regions that regulate appetite, the application of Wegovy® in obese patients can significantly reduce hunger, enhance satiety, and decrease food cravings, thereby assisting patients in reducing caloric intake and achieving weight loss. Moreover, through genetic engineering, Wegovy® has been successful in extending its half-life to 7 days, allowing for a once-weekly dosing regimen, providing Chinese patients with a safe and convenient weight management solution. Zhangkezhou, the Corporate Vice President of Pharmaceutical Quality at Novo Nordisk Greater China, stated that Novo Nordisk's research in the field of obesity treatment has spanned over 25 years, and the company has established a solid scientific foundation based on GLP-1RA therapy. The company is committed to comprehensively addressing the overall health of obese patients and aims to provide them with an integrated treatment plan. Looking ahead, Novo Nordisk will continue to lead the innovative breakthroughs in the field of obesity treatment to meet the diverse medical needs of Chinese patients. Zhou Xiaping, the Global Senior Vice President and President of Novo Nordisk Greater China, emphasizes that as a global leader in the field of obesity treatment, Novo Nordisk is dedicated to changing the world's perception, prevention, and treatment of obesity. Coinciding with Novo Nordisk China's 30th anniversary, Wegovy® as the company's latest innovative drug introduced to China will effectively address the unmet medical needs in the field of obesity treatment in China. The company is grateful for the support and guidance from the National Medical Products Administration and relevant government departments in accelerating the introduction of innovative drugs to China, as well as the contributions of researchers and participants in the clinical trials. Novo Nordisk will uphold its mission of "driving change and working together to overcome serious chronic diseases" and focus on patient-centricity, accelerating innovation, and diversifying and comprehensively contributing to the prevention and treatment of chronic diseases in China, supporting the "Healthy China 2030" initiative. It is hereby declared that the approved Wegovy® (for long-term weight management in adults) and the already marketed Ozempic® (for the treatment of type 2 diabetes in adults) are both prescription drugs, targeting different diseases and cannot be substituted for each other. About Wegovy® (semaglutide injection for long-term weight management) Wegovy® is the world's first and currently the only once-weekly GLP-1RA for long-term weight management, providing not only significant weight loss but also multiple health benefits. Wegovy® has been launched in over 10 countries and regions globally. Wegovy® is indicated for long-term weight management in adults with an initial body mass index (BMI) of: - BMI ≥ 30 kg/m² (obesity) - BMI 27 kg/m² to < 30 kg/m² (overweight) with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Wegovy® can achieve an average weight loss of 17% (16.8 kg) and provide multiple health benefits, including reduced waist circumference, decreased visceral fat, improved lipid profile, and delayed progression to type 2 diabetes. In the global STEP clinical trial series covering over 25,000 overweight and obese participants, as well as real-world data studies, Wegovy® has demonstrated good safety and tolerability. Its active ingredient, semaglutide, has up to 94% structural homology with human GLP-1 and has been extensively validated for its safety, used by 5.4 million patients globally. The most common adverse reactions of Wegovy® are mild to moderate transient gastrointestinal events. About the STEP Clinical Trial Series The STEP clinical trial series for Wegovy® (semaglutide injection for long-term weight management) started in June 2018 and has completed 14 trials to date, including 12 global Phase 3 trials, 1 regional Phase 3 trial in East Asia, and 1 regional Phase 3 trial primarily in China. These trials have study durations of 11-24 months, with an average maximum treatment period of 34 months, aiming to evaluate the efficacy, safety, and other health benefits of Wegovy® in the long-term weight management of adults. Overall, the STEP clinical trial data have shown that Wegovy® can significantly reduce the weight of adult overweight and obese patients across different regions, ethnicities, ages, and genders, with or without type 2 diabetes, with an average weight loss of 17% (16.8 kg), and has demonstrated good safety and tolerability.

Phase 3Drug ApprovalClinical Result

25 Jun 2024

·www.biospace.com

Endogenex™ Announces $88 Million Series C Financing to Complete Pivotal Trial of the ReCET™ System in Patients with Type 2 Diabetes

Oversubscribed financing led by strategic investor, with participation from new and existing investors MINNEAPOLIS, June 25, 2024 /PRNewswire/ -- Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes, announced it has closed an oversubscribed Series C financing totaling $88 million. The new capital will be used to complete the pivotal ReCET Clinical Study, which has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA). A group of new investors, including Hatteras Venture Partners, Lumira Ventures, and Orlando Health Ventures, joined an undisclosed strategic lead investor and existing investors Intuitive Ventures, Longitude Capital, Mayo Clinic, and Santé Ventures in the Series C funding. "We are excited to take this significant step forward in our mission to transform diabetes care," said Stacey Pugh, CEO of Endogenex. "This funding will enable us to complete our pivotal clinical study, bringing us closer to offering a groundbreaking solution for type 2 diabetes patients. The therapeutic landscape in diabetes continues to evolve, especially around the earlier use of SGLT2i and GLP-1RA. However, there remains a considerable unmet need to address the underlying pathophysiology and progression of the disease." "We are very proud of the company's progress, and this successful funding round is a testament to Endogenex's innovative technology," said Juliet Tammenoms Bakker, Endogenex Board Chair and Managing Director at Longitude Capital. "This milestone underscores our investors' confidence in the company's vision and the impact it can make in treating the epidemic of type 2 diabetes around the world." About the ReCET Clinical Study The ReCET Clinical Study is a multicenter, prospective, randomized, double-blinded, sham-controlled study assessing the safety and effectiveness of the ReCET System. The pivotal study received IDE approval in November 2023. The study will enroll up to 350 patients at clinical sites in the United States and Australia. About the ReCET™ Procedure ReCET is a novel, endoscopic outpatient procedure that targets the cellular pathology of the duodenum. This pathology may contribute to the development and progression of type 2 diabetes. The ReCET System aims to initiate the body's natural regenerative process by applying highly controlled, non-thermal pulsed electric fields to the mucosa and sub-mucosa duodenal tissue. This approach may help restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels. The ReCET System has been evaluated in feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were inadequately controlled despite using insulin and non-insulin medications. Preliminary outcomes from these studies have been presented at medical conferences globally. The ReCET System has received an FDA Breakthrough Device Designation for treating type 2 diabetes in adults inadequately controlled by glucose-lowering medications. About Endogenex™ Endogenex, founded in partnership with Mayo Clinic, aims to revolutionize treatment options for individuals with type 2 diabetes (T2D). The company's innovations focus on resetting the body's metabolic signaling system by harnessing its natural regenerative capabilities to improve metabolic function. Through the development of the ReCET System and the novel application of precise, controlled, non-thermal pulsed electric fields, Endogenex is establishing a new era in T2D therapy, helping patients regain control of their blood glucose levels and slow disease progression. For more information, please visit . Media Inquiries: Brent Collins bcollins@endogenex.com +1(612) 227-6949

Clinical Study

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	EU	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	IS	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	LI	Novo Nordisk A/S	18 Sep 2014
Diabetes Mellitus, Type 2	NO	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 3	US	Novo Nordisk A/S	20 Sep 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05324462 (SPIRIT, Pubmed)	Not Applicable	Diabetes Mellitus, Type 2	175	IDegLira	eywzflexqi(aeuadvibkr) = nsixivazku nkvneponkt (wtrcbvgnzv ) View more	Positive	08 May 2024
NCT03737240 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	145	IDegLira (IDegLira)	kbaqcumccm(xprljczrlk) = hqtddmwuqa cczbnoowno (blnbrialdr, whqanndolw - wvrozbjxha) View more	-	08 Sep 2023
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	kbaqcumccm(xprljczrlk) = qgvytrocjo cczbnoowno (blnbrialdr, hkfspkuidv - xsuaevxuwe) View more
EASD2022	Not Applicable	Fractures, Bone	-	GLP-1RA	miajhuijbx(soljvksxmj): HR = 0.89 (95% CI, 0.76 - 1.05)	Positive	22 Sep 2022
				DPP-4i
EASD2022	Not Applicable	Diabetes Mellitus, Type 2 HbA1c \| c-peptide	73	Human BBT	kjmxkcaaui(vwzqneazvy) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia lctqtiaqzt (wuhzsqtkam )	Positive	20 Sep 2022
				IDegLira
IDegLira-HIGH Trial (ADA2022)	Not Applicable	Diabetes Mellitus, Type 2	-	IDegLira	yakujtxqbp(tlygnvulkh) = phbcmpxcto vdujgncaxy (mgzgsjrrha ) View more	Positive	01 Jun 2022
				Basal Bolus	yakujtxqbp(tlygnvulkh) = odzowjrgyg vdujgncaxy (mgzgsjrrha ) View more
NCT03172494 (DUAL I China, Pubmed)	Phase 3	Diabetes Mellitus, Type 2	720	IDegLira	cktnowdyus(bainjnzfpu): ETD = -6.5 (95% CI, -7.96 to -5.04) View more	Positive	01 Jun 2022
				Degludec
NCT03175120 (DUAL II China, EASD2020)	Phase 3	-	453	IDegLira	bzifadsagb(edwhaepmom): 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	uxtsamflfu(icbkqjbmts): ETD = -0.59 (95% CI, -0.73 to -0.46) View more	Positive	23 Sep 2020
				IDeg
NCT03172494 (DUAL I China, CTgov)	Phase 3	Diabetes Mellitus, Type 2	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	fqbgtobrvc(esenvslths) = rewovifpou syiygltrvq (qjmkxvqwoz, wppjlzboyh - wphgdnjmrz) View more	-	07 Jul 2020
				Insulin degludec (Insulin Degludec)	fqbgtobrvc(esenvslths) = hesizdvzwj syiygltrvq (qjmkxvqwoz, snccikmkzx - ozpynqiafz) View more
NCT03175120 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	453	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	jflfcufoml(dyoguyxklb) = pylbzvxkae gnvbsljogq (pmmvaqszpp, jcdzdgfflx - yltrtmuztc) View more	-	19 Mar 2020
				Insulin degludec (Insulin Degludec)	jflfcufoml(dyoguyxklb) = svawyepyiu gnvbsljogq (pmmvaqszpp, tvwsndfyis - jradpcfyiq) View more

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