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.

开始日期2024-11-07

申办/合作机构

Novo Nordisk A/S

NCT06408532

/ Not yet recruiting临床4期IIT

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.

开始日期2024-04-30

申办/合作机构

北京大学人民医院

JPRN-UMIN000052156

/ RecruitingN/AIIT

Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels - Conparison of IDegLira vs IDeg in multiple daily injection therapy

开始日期2023-09-05

申办/合作机构-

100 项与德谷胰岛素/利拉鲁肽相关的临床结果

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100 项与德谷胰岛素/利拉鲁肽相关的专利（医药）

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项与德谷胰岛素/利拉鲁肽相关的文献（医药）

2025-09-11·CURRENT DIABETES REVIEWS

Efficacy and Safety of IDegLira in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Article

作者: Liu, Delong ; Yang, Zhiyong ; Su, Ning ; Zhang, Lina ; Bai, Lexie

Introduction::

Clinical trials indicate that IDegLira is effective in treating type 2 diabetes mellitus (T2DM). This study aims to assess the efficacy and safety of IDegLira in type 2 diabetes mellitus (T2DM) comprehensively.

Methods::

To identify relevant randomized controlled trials, we searched PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov. Risk Ratios (RR) and 95% Confidence Intervals (CI) were calculated using the Mantel-Haenszel approach for dichotomous outcomes. Mean Difference (MD) and 95% CI calculated by the inverse variance approach were applied to continuous outcomes.

Results::

Twelve randomized controlled trials involving 7628 participants were included in this study. Compared with control groups, IDegLira has a significant hypoglycemic effect in reducing hemoglobin A1c (MD = −0.66; 95% CI [−0.85, −0.47]; p < 0.00001), fasting plasma glucose (MD = −0.90; 95% CI [−1.40, −0.41]; p = 0.0003), self-measured plasma glucose (MD = −0.82; 95% CI [−1.22, −0.42]; p < 0.0001) and achieving the hemoglobin A1c level of < 7.0%(RR = 1.66; 95% CI [1.44, 1.92]; p < 0.00001) or < 6.5% (RR = 2.13; 95% CI [1.76, 2.57]; p < 0.00001). IDegLira outperforms insulin in achieving the target of HbA1c < 7.0 or < 6.5% without hypoglycemia and weight gain. Besides, IDegLira did not increase the incidence of adverse events and serious adverse events.

Discussion::

In this section, IDegLira’s benefits on simultaneously achieving glycemic control, weight loss, and reduced hypoglycemia risk were summarized. The statistical results were carefully interpreted in conjunction with clinical concerns regarding T2DM complications, adverse effects, and cost-effectiveness differences. An expanded discussion was conducted on integrating individualized HbA1c goals as a dual endpoint, without increasing body weight or the risk of hypoglycemia. Finally, the limitations of the present study are indicated.

Conclusions::

IDegLira exhibits a favorable glycemic control effect and acceptable adverse effects in Type 2 Diabetes Mellitus (T2DM). Superior performance in the target glycemic control, particularly suitable for T2DM patients who do not reach the target hemoglobin A1c and have comorbid CVD or obesity.

2025-09-01·DIABETOLOGIA

Insulin DEgludec/LIraglutide versus multiple daily insulin injections in the transition from hospital to outpatient management assessed by continuous glucose monitoring: the DELI transition trial

Article

作者: Gómez-Medina, Ana M ; Pertuz-Noriega, Carlos E ; Gómez-Quesada, Yaline ; Villamil-Castañeda, Lina P ; Muñoz-Velandia, Oscar M ; Chaim, Salma N ; Aschner, Pablo ; Yepes, Carlos A ; Henao-Carillo, Diana C

Abstract:

Aims/objective:

The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels <3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting.

Methods:

The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8–10 mmol/l), the time below range (TBR <3.0 or <3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring.

Results:

Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA1c of 103 ± 11.6 mmol/mol (11.6 ± 1.7%) and age of 58 ± 12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose <3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; p<0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; p<0.001), TBR <3.8 mmol/l (0.9% vs 2.9%; p=0.019) and TBR <3.0 mmol/l (0.6% vs 1.3%, p=0.008). The TIR 3.8–10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; p=0.008). The findings were consistent regardless of baseline HbA1c.

Conclusions/interpretation:

IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care.

Trial registration:

Clinicaltrials.gov NCT05767255

Funding:

This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).

Graphical Abstract:

2025-08-01·DIABETES OBESITY & METABOLISM

What is the ‘real‐world’ experience with fixed‐ratio combination therapy (insulin + GLP‐1 receptor agonist) in routine clinical practice? Take‐home messages for clinicians regarding key outcomes

Review

作者: Frias, Juan Pablo

Abstract:

Aims:

The fixed‐ratio combinations (FRCs) of a basal insulin and glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA), IDegLira (insulin degludec/liraglutide) and iGlarLixi (insulin glargine/lixisenatide), offer a once‐daily injectable treatment option for adults with type 2 diabetes (T2D), combining complementary mechanisms of action to target both fasting and postprandial hyperglycaemia. While randomized controlled trials have demonstrated their efficacy and safety, real‐world evidence (RWE) provides important insights into their effectiveness, tolerability and use across routine clinical practice.

Materials and Methods:

This is a narrative review of selected real‐world studies assessing the FRCs IDegLira and iGlarLixi in adults with T2D. Studies assessing the use of FRCs to intensify and simplify therapy, as well as their use in special populations such as older adults were reviewed and are summarized.

Results:

Among individuals inadequately controlled on oral antihyperglycaemic drugs (OADs), basal insulin ± OADs, or GLP‐1 RAs, initiation of FRC therapy consistently improved glycaemic outcomes, supported modest weight loss or stability, and was associated with a low risk of hypoglycaemia. FRCs have also been evaluated as a strategy for simplifying complex insulin regimens. Transitions from basal–bolus or premixed insulin to FRCs maintained or improved glycaemic control while reducing total daily insulin dose and injection burden.Evidence in special populations and clinical contexts further supports the utility of FRCs. In older adults, FRC use was associated with reductions in HbA1c and hypoglycaemia risk, along with improvements in treatment satisfaction and functional measures. During Ramadan fasting, iGlarLixi demonstrated favourable glycaemic control, low hypoglycaemia incidence, modest weight loss and high adherence. Studies assessing glycaemic control using continuous glucose monitoring showed improvements in time in range, reductions in time above range and stable time below range, indicating enhanced glycaemic stability without increased risk of hypoglycaemia.Two real‐world head‐to‐head studies comparing IDegLira and iGlarLixi found both FRCs to be effective and well tolerated. IDegLira was associated with greater weight loss and lower insulin dose requirements, while iGlarLixi showed advantages in postprandial glucose control. Both agents demonstrated significant improvements in HbA1c and low rates of hypoglycaemia.

Conclusions:

Collectively, these real‐world studies confirm that FRCs are effective, safe and patient‐centred treatment options for adults with T2D. Their simplified dosing, metabolic benefits and favourable safety profiles support their use for both therapy intensification and de‐intensification across a broad spectrum of clinical scenarios. These findings reinforce results from randomized controlled trials, providing further confidence in the role of FRCs in contemporary diabetes care.

项与德谷胰岛素/利拉鲁肽相关的新闻（医药）

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. 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上市批准

2025-08-29

·EINPresswire

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. 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Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. 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上市批准

2025-07-11

·药事纵横

诺和诺德将斥资8亿元在天津新建质检实验室

诺和诺德于周二与天津经济技术开发区（TEDA）签署协议，投资8亿元人民币（约合1.12亿美元）升级其天津生产设施的质检实验室——该基地自1994年投入运营至今。根据TEDA中文新闻稿，新检测设施预计占地约1.8万平方米（约合19.4万平方英尺），涵盖化学、生物学及微生物学实验室。项目预计于2026年底竣工，诺和诺德将启用该设施承担天津工厂的质量控制检测任务。该基地是这家丹麦制药公司全球七大核心生产基地之一。TEDA未披露新实验室将检测的具体药物，但该公司天津基地近期其他项目集中于预填充注射笔生产及无菌药品制造（如诺和泰® Ozempic® 和诺和益® Wegovy®）。信息来源：https://www.fiercepharma.com/manufacturing/novo-keeps-china-manufacturing-investments-rolling-112m-new-quality-testing-lab药事纵横投稿须知：稿费已上调，欢迎投稿

100 项与德谷胰岛素/利拉鲁肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE56	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	欧盟	Novo Nordisk A/S	2014-09-18
2型糖尿病	冰岛	Novo Nordisk A/S	2014-09-18
2型糖尿病	列支敦士登	Novo Nordisk A/S	2014-09-18
2型糖尿病	挪威	Novo Nordisk A/S	2014-09-18

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病	临床1期	德国	Novo Nordisk A/S	2009-09-01

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05324462 (SPIRIT, Pubmed) 人工标引	N/A	2型糖尿病	175	IDegLira	願夢鏇簾繭糧網鏇願淵(夢獵窪憲繭築觸餘積憲) = 夢膚獵憲願構顧膚廠襯範鏇選鹹選餘夢製觸簾 (獵夢簾積膚廠齋鏇繭鬱, - 1.6 ~ - 1.0) 更多	积极	2024-05-08
NCT03737240 (CTgov)	临床3期	2型糖尿病	145	IDegLira (IDegLira)	糧遞簾鬱襯選網顧構齋(簾醖膚憲獵鏇積鹽憲網) = 衊醖齋顧夢鹹艱鏇蓋繭繭簾膚觸範襯襯選積齋 (廠艱簾鑰淵糧膚選遞廠, 2.29) 更多	-	2023-09-08
				Insulin Degludec (U-100)+Insulin Aspart (Basal-Bolus Insulin)	糧遞簾鬱襯選網顧構齋(簾醖膚憲獵鏇積鹽憲網) = 繭鑰膚顧遞繭膚鏇獵糧繭簾膚觸範襯襯選積齋 (廠艱簾鑰淵糧膚選遞廠, 1.79) 更多
EASD2022	N/A	2型糖尿病 HbA1c \| c-peptide	73	Human BBT	築艱憲遞網築觸觸鬱繭(顧鹹夢壓醖顧選壓鹹選) = 10 (18%) patients reported at least one episode and 6 (10%) patients had more than one episode of mild hypoglycemia 夢顧顧獵鬱衊選網網鬱 (積願壓壓齋膚夢襯餘廠 )	积极	2022-09-20
				IDegLira
NCT03175120 (DUAL II China, EASD2020)	临床3期	2型糖尿病	453	IDegLira	餘顧製顧簾廠鏇繭廠膚(衊衊衊遞鬱膚鬱壓繭觸): P-Value = <0.0001 更多	积极	2020-09-23
				Insulin degludec
NCT03172494 (DUAL I China, EASD2020)	临床3期	2型糖尿病	720	IDegLira	鏇網積遞製繭廠鑰夢糧(憲選獵蓋網壓繭夢製壓): ETD = -0.59 (95% CI, -0.73 ~ -0.46) 更多	积极	2020-09-23
				IDeg
NCT03172494 (DUAL I China \| DUAL™ I China, CTgov)	临床3期	2型糖尿病	720	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	簾齋鏇願遞獵願鹹糧蓋(憲夢鹽窪壓淵積鏇糧衊) = 鏇築網鏇築壓繭簾獵糧鹽壓淵廠選鬱淵簾範願 (鏇顧構淵顧餘築願積蓋, 0.88) 更多	-	2020-07-07
				Insulin Degludec (Insulin Degludec)	簾齋鏇願遞獵願鹹糧蓋(憲夢鹽窪壓淵積鏇糧衊) = 蓋壓壓廠觸艱鬱艱壓餘鹽壓淵廠選鬱淵簾範願 (鏇顧構淵顧餘築願積蓋, 0.99) 更多
NCT03175120 (DUAL™ II China \| DUAL II China, CTgov)	临床3期	2型糖尿病	453	Insulin degludec/liraglutide (Insulin Degludec/Liraglutide)	襯壓繭糧衊鏇築壓簾簾(構醖鏇鏇夢壓艱製製製) = 觸衊膚網艱鹹積獵蓋壓遞鏇蓋窪鏇夢淵衊築壓 (簾鏇壓遞廠窪積構艱構, 1.14) 更多	-	2020-03-19
				Insulin Degludec (Insulin Degludec)	襯壓繭糧衊鏇築壓簾簾(構醖鏇鏇夢壓艱製製製) = 繭廠繭繭製醖夢網鏇夢遞鏇蓋窪鏇夢淵衊築壓 (簾鏇壓遞廠窪積構艱構, 1.19) 更多
NCT02420262 \| NCT01952145 (Pubmed \| Diabet Med)	临床3期	2型糖尿病	-	Insulin degludec/liraglutide (IDegLira)	齋遞鏇顧齋獵鑰網遞廠(鏇觸繭顧膚蓋鏇膚鹽繭) = 鬱構範獵網選獵簾鑰鏇繭鹹艱鏇製淵築鹹網選 (網鏇範鏇艱醖鑰築觸衊 ) 更多	-	2020-02-01
NCT02911948 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	210	metformin+degludec/liraglutide	壓衊齋網簾壓構選築衊(糧選憲鏇窪獵壓廠糧艱): ETD = -13.98 (95% CI, -16.41 ~ -11.55), P-Value = <0.0001 更多	优效	2019-12-01
				metformin+degludec
NCT02501161 (DUAL™ VIII \| DUAL Ⅷ \| DUAL VIII, CTgov)	临床3期	2型糖尿病	1,012	Insulin Degludec+Liraglutide (Insulin Degludec/Liraglutide)	餘衊淵築築積鏇衊選醖(衊鏇顧遞觸夢觸鏇網遞) = 壓願繭築製鹹築簾觸醖鹹觸網鹽鹽襯鏇憲膚積 (顧鹽築衊醖範鏇蓋憲觸, 壓襯鏇淵廠顧憲醖顧膚 ~ 製蓋鹹觸窪構膚遞餘範) 更多	-	2019-11-27
				Insulin Glargine (Insulin Glargine)	餘衊淵築築積鏇衊選醖(衊鏇顧遞觸夢觸鏇網遞) = 觸簾構壓齋願願製鑰窪鹹觸網鹽鹽襯鏇憲膚積 (顧鹽築衊醖範鏇蓋憲觸, 繭憲遞觸鹽壓鑰獵鬱襯 ~ 餘餘艱積鹽積衊構網鏇) 更多