Pharmacokinetics and Safety of Insulin Degludec/Insulin Aspart Injection with the Ryzodeg Produced by Novo Nordisk in Healthy Chinese Subjects: A phase I, Randomized, Open-label, Single-dose, Two-phase, Crossover study

Start Date28 Mar 2022

Sponsor / Collaborator-

NCT05221580

/ CompletedNot Applicable

A Prospective Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in China

The purpose of this study is to collect information on how Ryzodeg® works in real-world patients.
Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment

Start Date18 Mar 2022

Sponsor / Collaborator

Novo Nordisk A/S

NCT04892069

/ CompletedNot Applicable

A Retrospective, Single Centre, Non-interventional Study Investigating the Effect of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in Lebanon

The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.

Start Date27 May 2021

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Insulin Degludec / Insulin Aspart

100 Translational Medicine associated with Insulin Degludec / Insulin Aspart

100 Patents (Medical) associated with Insulin Degludec / Insulin Aspart

120

Literatures (Medical) associated with Insulin Degludec / Insulin Aspart

01 Mar 2025·DIABETES OBESITY & METABOLISM

Improved glycaemic control in people with type 2 diabetes initiating or switching to IDegAsp in a real‐world setting in China

Article

Author: Chen, Liming ; Zhong, Xing ; Guo, Lixin ; Chaudhary, Gaurav ; Liu, Xiaoyun ; Shankarappa, Vinay Babu ; Wang, Kun ; Ding, Hongcheng ; Zhao, Fan

Abstract:

Aims:

To investigate glycaemic control in Chinese adults with type 2 diabetes (T2D) initiating, or switching to insulin degludec/insulin aspart (IDegAsp), a co‐formulation of basal, and bolus insulin, in a real‐world setting.

Materials and Methods:

A 20‐week, prospective, single‐arm, open‐label, non‐interventional study was conducted in Chinese adults with T2D initiating, or switching to IDegAsp after anti‐hyperglycaemic treatment with oral antidiabetic drugs (OADs), other insulins, or glucagon‐like peptide‐1 receptor agonists. The primary endpoint was a change in HbA1c from baseline to end of the study; the secondary endpoints included a change in fasting plasma glucose and Diabetes Treatment Satisfaction Questionnaire (DTSQ) score.

Results:

Significant reductions were observed in mean HbA1c and fasting plasma glucose, among both the overall population (N = 878; −1.27%‐points [95% CI: −1.36; −1.19]; p < 0.0001, and −1.61 mmol/L [95% CI: −1.81; −1.41]; p < 0.0001, respectively), and in subgroups switching from OADs only, or basal, or premix insulins ± OADs. The mean total DTSQ score increased from 26.4 (baseline) to 31.6 (end‐of‐study). No significant, or unexpected tolerability, or safety issues were observed. Significant reductions were observed in incidence rates of non‐severe (rate ratio 0.37 [95% CI: 0.24; 0.59]; p < 0.0001) and nocturnal non‐severe (rate ratio 0.45 [95% CI: 0.21; 0.94]; p = 0.0326) hypoglycaemic episodes.

Conclusions:

In a broad, real‐world Chinese population of adults with T2D, initiating or switching to IDegAsp was associated with improved glycaemic control and lower rates of hypoglycaemia. The use of IDegAsp could be an effective treatment option for those with suboptimal glycaemic control or therapeutic inertia.

01 Feb 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Evaluation of pharmacokinetic and pharmacodynamic similarity of an IDegAsp biosimilar versus the originator in healthy Chinese volunteers

Article

Author: Liu, Hui ; Wang, Wenjia ; Chen, Xinlei ; Guo, Linfeng ; Yu, Yerong ; Huang, Kanghua ; Zhuang, Yulei ; He, Wengang ; Lan, Li ; Deng, Li ; Yu, Hongling ; Xiong, Yang

OBJECTIVES:

22011 is an insulin degludec/insulin aspart co-formulation (IDegAsp) that shares an identical amino acid sequence with Ryzodeg, the originator IDegAsp. This study aimed to compare the pharmacokinetics (PK), pharmacodynamics (PD), and safety of 22,011 with Ryzodeg.

METHODS:

In a single-center, randomized, open-label, two-treatment, two-period, two-sequence, crossover, euglycemic clamp study, healthy Chinese adults were randomized to receive 0.5 U/kg of 22,011 and Ryzodeg under fasting conditions. PK was evaluated for up to 120 hours and PD (represented by glucose infusion rate [GIR]) was assessed for up to 24 hours.

RESULTS:

Of 46 subjects randomized, all completed both treatment periods and were included in the PK/PD and safety analysis set. Insulin exposure (AUC_{IDeg, 0-24 h}, AUC_{IAsp, 0-12 h}, and C_{max, IAsp}) and activity (GIR_max and AUC_{GIR, 0-24 h}) were comparable (estimates of treatment ratios 0.916 ~ 1.076 for primary PK parameters and 0.946 ~ 1.037 for primary PD parameters), with 90% confidence intervals for the ratios of least square means falling within the range of 0.80 ~ 1.25. Adverse events were similar for both products and no significant safety concerns were noted in the laboratory results, vital signs, or electrocardiogram.

CONCLUSION:

This study demonstrated the PK/PD similarity of 22,011 to Ryzodeg with a comparable safety profile.

01 Jan 2025·Endocrinology Diabetes and Metabolism Case Reports

Severe palmoplantar keratoderma: a cutaneous complication from sub-optimally controlled type 2 diabetes

Article

Author: Iqbal, Fatima ; Cheung, Wah N ; Phan, Kevin

Summary:

Palmoplantar keratoderma (PPK), characterised by excessive epidermal thickening of the skin on the palms and/or plantar surfaces of the feet, can be hereditary or acquired. Here, we report a case of a 53-year-old woman with a history of sub-optimally controlled diabetes mellitus presenting with fevers and decreased Glasgow Coma Scale (GCS) to a tertiary hospital. She was diagnosed with diabetic ketoacidosis (DKA), with blood glucose at 40 mmol/L and ketones at 7 mmol/L, in the setting of a methicillin-sensitive Staphylococcus aureus necrotising soft tissue back infection. Her medical history included diabetes managed with insulin but no engagement with an endocrinologist or allied health support. Examination revealed an infected, necrotic back wound on her left mid-upper back that required surgical debridement and broad-spectrum IV antibiotics. In addition, she exhibited marked plantar keratoderma and onychogryphosis, reportedly present and worsening over approximately two years. She was prescribed 40% urea cream twice daily, resulting in gradual sloughing of the hyperkeratotic skin within a few weeks. Her HbA1c was 10.4%, and she tested negative for diabetes antibodies, indicating type 2 diabetes. Treatment included an insulin–dextrose infusion until DKA resolved, followed by twice daily insulin degludec/aspart (Ryzodeg 70/30) and metformin. The PPK was attributed likely secondary to sub-optimally managed diabetes.

Learning points:

Diabetes mellitus has multiple complications, including rare dermatologic manifestations such as PPK.This case illustrates the importance of thorough skin assessments in patients with diabetes, particularly those that have a history of sub-optimal diabetes control.A multidisciplinary approach, integrating dermatology, endocrinology and allied health services such as podiatry, is essential in managing diabetes-related complications, improving patient quality of life and preventing further complex manifestations.

News (Medical) associated with Insulin Degludec / Insulin Aspart

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

15 Oct 2024

·pipelinereview.com

Gan & Lee Pharmaceuticals' Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies

BEIJING, China I October 15, 2024 I Recently, Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that three of its independently developed drugs — the bi-weekly GLP-1 receptor agonist GZR18 injection, the once-weekly basal insulin analog GZR4 injection, and the premixed dual insulin analog GZR101 injection — successfully achieved positive results in three Phase 2 clinical trials conducted in adult patients with Type 2 diabetes (T2D) in China. In these studies, Gan & Lee’s three innovative drugs demonstrated superior or comparable efficacy in lowering glycated hemoglobin (HbA1c) compared to the respective positive comparator drugs separately. Gan & Lee Pharmaceuticals’ Diabetes Product Portfolio Diagram Statement: 1. GZR18, GZR4, and GZR101 are investigational drugs that have not yet been approved in China. 2. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. GZR18 Injection: a Phase 2 Study evaluate the Efficacy and Safety of GZR18 Injective vs. Semaglutide (Ozempic ® ) in Chinese Patients with Type 2 Diabetes The Phase 2b clinical trial (CTR20232069) is a multicenter, randomized, open-label study comparing the efficacy and safety of GZR18 injection versus semaglutide (Ozempic ® ) in Chinese adult T2D patients with poor glycemic control on lifestyle interventions and/or unregulated use of anti-diabetic drugs, and on oral anti-diabetic treatment for at least three months. A total of 264 subjects were recruited across 25 clinical centers in China. Patients were randomized to receive bi-weekly GZR18 injections (12 mg, 18 mg, or 24 mg) or once-weekly 24 mg GZR18 injections, or 1 mg semaglutide for 24 weeks, including the dose-escalation period. The primary efficacy endpoint was the change in HbA1c from baseline after 24 weeks of continuous treatment. The subjects had a mean diabetes history of 11-18 years, and baseline HbA1c ranged from 8.28% to 8.56%. After 24 weeks of treatment, the mean HbA1c reduction from baseline in the GZR18 groups was as follows: 1.87% (12 mg, bi-weekly), 2.28% (18 mg, bi-weekly), 1.94% (24 mg, bi-weekly), and 2.32% (24 mg, once-weekly), all higher than the semaglutide group (1.60% reduction)*. Additionally, in treatment-naïve patients with poor glycemic control on lifestyle interventions, the HbA1c reduction in the bi-weekly GZR18 injection group reached 2.98%, compared to 2.04% in the semaglutide group, with a significant HbA1c reduction (p < 0.05)*. After 24 weeks of treatment, patients in the bi-weekly GZR18 group experienced a maximum weight loss of 5.42 kg, compared to 3.25 kg in the semaglutide group*. GZR18 also greatly improved fasting glucose, blood pressure, and lipid levels, etc, providing comprehensive benefits for diabetic patients. GZR18 was generally well-tolerated, with safety and tolerability consistent with known GLP-1 receptor agonists. The most common adverse events were gastrointestinal-related, and no severe hypoglycemic events were observed. GZR4 Injection: a Phase 2 Study Comparing the Efficacy and Safety of GZR4 injection vs. insulin degludec (Tresiba ® ) in Chinese Patients with Type 2 Diabetes The Phase 2 trial (CTR20232431) was a multicenter, randomized, open-label, parallel-group study evaluating the efficacy, tolerability and safety of once-weekly GZR4 injections versus once-daily insulin degludec (Tresiba ® ) in 83 T2D patients with poor glycemic control on oral antidiabetic drugs (Part A) and 96 T2D patients with poor glycemic control on a combination of oral antidiabetic drugs and basal insulins (Part B). In part A, the mean HbA1c reduction of once-weekly GZR4 injection was 1.50%, comparable to insulin degludec’s reduction of 1.48%. In part B, GZR4 injection demonstrated a superior HbA1c reduction of 1.26%, compared to -0.87% for insulin degludec (treatment difference: -0.38%, p < 0.01)*. In addition, improvements in time-in-range (TIR) were comparable between GZR4 and insulin degludec. In this study, GZR4 injection showed good safety and tolerability, with no severe hypoglycemic events observed. GZR101 Injection: a Phase 2 Study Comparing the Efficacy and Safety of GZR101 injection vs. insulin degludec/insulin aspart (Ryzodeg ® ) in Chinese Patients with Type 2 Diabetes The Phase 2 clinical trial (CTR20232431) is a multicenter, randomized, open-label, parallel-controlled, treat-to-target Phase 2 study. Part A of the study aimed to compare the efficacy, safety, and tolerability of GZR101 injection administered once-daily versus insulin degludec/insulin aspart (Ryzodeg ® ) administered once-daily over 16 weeks in 62 patients with uncontrolled T2D on oral anti-diabetic drugs. In Part B, the study compared the efficacy, safety, and tolerability of GZR101 injection combined with insulin aspart versus insulin degludec/insulin aspart (Ryzodeg ® ) administered twice-daily over 16 weeks in 91 patients with uncontrolled T2D on basal/premixed insulin. In Part A, the HbA1c levels in the once-daily GZR101 injection group decreased by 1.56%, superior to the -1.31% reduction in the once-daily insulin degludec/insulin aspart group (treatment difference: -0.24%). In Part B, GZR101 injection combined with insulin aspart achieved HbA1c reductions of -1.64% (once-daily insulin aspart) and -1.68% (twice-daily insulin aspart), both higher than the -1.59% reduction in the twice-daily insulin degludec/insulin aspart group (treatment differences of -0.06% and -0.09%, respectively)*. Moreover, GZR101 injection demonstrated comparable efficacy to insulin degludec/insulin aspart in controlling fasting and postprandial blood glucose, as well as improving time-in-range (TIR). In this trial, GZR101 injection showed good safety and tolerability. The estimated incidence of hypoglycemic events in both groups did not show statistically significant differences during the study. *The trial results are presented as least squares means (LS mean). Note: severe hypoglycemia is defined as Grade 3 hypoglycemia (serious events without specific plasma glucose boundaries, with conscious and/or somatic changes, hypoglycemia requiring help from others). Dr. Zhong-ru Gan, Chairman of Gan & Lee Pharmaceuticals, stated: “The positive results achieved by GZR18, GZR4, and GZR101 in Phase 2 clinical trials mark an important milestone in improving the current landscape of diabetes treatment. These results demonstrate that our three products provide better glycemic control compared to similar antidiabetic drugs. Over the years, we have successfully launched a full range of insulin products, from human insulin to insulin analogs, covering both basal and mealtime insulin, in the hope of comprehensively meeting the treatment needs of different diabetes patients. With recent breakthroughs in our research and development, we have also expanded our product portfolio with oral antidiabetic drugs, filling a gap in this critical area. Focusing on the frontiers of the endocrine field, we are actively promoting the development of new drugs, aiming to achieve comprehensive management of chronic metabolic diseases, including diabetes and obesity. Gan & Lee’s product portfolio currently covers next-generation insulin based on the extension to emerging metabolic disease targets, such as GLP-1 receptor agonists, supporting patients throughout their treatment journey with a view to driving changes in the management of diabetes and metabolic diseases and improving the quality of life of patients.” Forward-Looking Statements: These forward-looking statements are based on expectations and assumptions as of the date of this release. Due to various factors, actual results may differ significantly. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Reference 1. WANCAI XING, WEI CHEN, YINING ZHANG, JING GAO, ANSHUN HE, JUN ZHANG, YING DENG, FANGKAI XUE, YONGCHUN WANG, HAO FU, RUNYAO ZHANG, JINHUI HUANG, ZHONGRU GAN; 823-P: Molecular and Pharmacological Properties of GZR4, a Once-Weekly Insulin Analog. Diabetes 14 June 2024; 73 (Supplement_1): 823–P. https://doi.org/10.2337/db24-823-P About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin ® ), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin ® ), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin ® 30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin ® 30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine ® ). In China’s 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine ® ) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. Further Information: BPRD@ganlee.com (Media) BD@ganlee.com (Business Development) info.medical@ganlee.com (Medical Information) SOURCE: Gan & Lee Pharmaceuticals

Clinical ResultPhase 2Drug Approval

15 Oct 2024

·www.prnewswire.com

Gan & Lee Pharmaceuticals' Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies

After 24 weeks of treatment in patients with Type 2 diabetes, the bi-weekly GLP-1 receptor agonist GZR18 injection showed superior efficacy in lowering HbA1c and body weight compared to semaglutide (Ozempic®). After 16 weeks of treatment in patients with Type 2 diabetes, the once-weekly insulin analog GZR4 injection demonstrated superior HbA1c reduction in patients with uncontrolled diabetes on basal insulins, compared to insulin degludec (Tresiba®). After 16 weeks of treatment in patients with Type 2 diabetes, the premixed dual insulin analog GZR101 injection showed superior efficacy in reducing HbA1c and postprandial glucose compared to insulin degludec/insulin aspart (Ryzodeg®). BEIJING, Oct. 15, 2024 /PRNewswire/ -- Recently, Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that three of its independently developed drugs — the bi-weekly GLP-1 receptor agonist GZR18 injection, the once-weekly basal insulin analog GZR4 injection, and the premixed dual insulin analog GZR101 injection — successfully achieved positive results in three Phase 2 clinical trials conducted in adult patients with Type 2 diabetes (T2D) in China. In these studies, Gan & Lee's three innovative drugs demonstrated superior or comparable efficacy in lowering glycated hemoglobin (HbA1c) compared to the respective positive comparator drugs separately. Gan & Lee Pharmaceuticals' Diabetes Product Portfolio Diagram

Clinical ResultPhase 2

100 Deals associated with Insulin Degludec / Insulin Aspart

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	European Union	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	Iceland	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	Liechtenstein	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	Norway	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus, Type 1	Japan	Novo Nordisk A/S	25 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	Australia	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Denmark	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Finland	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	India	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Malaysia	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Poland	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Sweden	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Taiwan Province	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Thailand	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	Turkey	Novo Nordisk A/S	05 Nov 2009

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


U1111-1241-6269 (ADA2024)	Not Applicable	Diabetes Mellitus, Type 2	55	Insulin Degludec/Insulin Aspart	ixfuzjlcxk(rmenifkzez) = yybkxcpfpc ojxzgmjpvp (yyvsvmwoaz, 0.40 ± 0.17 U/kg)	Positive	14 Jun 2024
				Insulin Glargine	ixfuzjlcxk(rmenifkzez) = frszkgoipc ojxzgmjpvp (yyvsvmwoaz, 0.39 ± 0.18 U/kg)
NCT05221580 (19-PUB, ADA2024)	Not Applicable	Diabetes Mellitus, Type 2	878	Insulin Degludec/Insulin Aspart (IDegAsp)	fndgbcaoek(phyyzuckzz) = iefvppnspc scfvojlkah (mnpkhdqxhc, -1.36 to -1.19) View more	Positive	14 Jun 2024
ADA2022	Not Applicable	-	535	IDegAsp	cqamrhpmzk(kpfiwsidik) = ccmxlqlvcg xmjdriurwk (eijcmgbckg ) View more	-	01 Jun 2022
NCT02821052 (Pubmed \| Adv Ther)	Not Applicable	Diabetes Mellitus	1,321	Insulin Degludec/Insulin Aspart	yeealzlgeq(vzzcxyafbu) = jdxepkzrya folqhvseiv (iatjkqhmkr, 3.4 - 5.8) View more	-	20 Nov 2021
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	324	Once-daily IDegAsp	ettcvbyqry(kncenvouoy) = sfnwkjrhnz vwgcpdtzfh (uoehtuqmrf ) View more	-	01 Jun 2021
				Basal insulin	ettcvbyqry(kncenvouoy) = ujvmcyhhkv vwgcpdtzfh (uoehtuqmrf ) View more
NCT02762578 (BOOST, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	543	insulin degludec/insulin aspart	pxxpisjxdd(ioqfsukwqw) = Non-inferiority for change from baseline to week 26 in HbA1c sgguvfijdc (bscibuusza ) View more	Superior	01 Jul 2019
				biphasic insulin aspart 30
NCT01059812 \| NCT01009580 (BOOST INTENSIFY PREMIX I (NCT01009580) and BOOST INTENSIFY ALL (NCT01059812), Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp	xrlushyndr(onzygktpvv) = similar for IDegAsp versus BIAsp 30 yvypmrtftj (xpfoqiydxz ) View more	-	01 Feb 2019
				BIAsp 30
NCT02762578 (BOOST, CTgov)	Phase 3	Diabetes Mellitus, Type 2	543	insulin degludec/insulin aspart (IDegAsp BID)	csayqyyvsg(qohhjouqxe) = tiiisnmveu firycnmaae (xauykftrdy, 0.05) View more	-	07 Dec 2018
				biphasic insulin aspart (BIAsp 30 BID)	csayqyyvsg(qohhjouqxe) = fbhpitcquj firycnmaae (xauykftrdy, 0.06) View more
NCT01835431 (Pubmed \| Pediatr Diabetes) Manual	Phase 3	Diabetes Mellitus, Type 1	362	insulin degludec/insulin aspart	ctxypkhlnn(kvgarzsfbw) = oymmeoizdj dqzckthhmr (spqhybvkhl )	Non-inferior	01 Nov 2018
				Insulin detemir+insulin aspart	ctxypkhlnn(kvgarzsfbw) = vucqihsfbg dqzckthhmr (spqhybvkhl )
NCT02906917 (EASD2018)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp QD	mpojepfegw(hmxebvwbpz) = fdzqfybiyd hcxdtgtqbw (elscsmcrhu ) View more	Positive	04 Oct 2018
				Glargine U100 QD + IAsp QD	mpojepfegw(hmxebvwbpz) = gjsithplsy hcxdtgtqbw (elscsmcrhu ) View more

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