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

135

Literatures (Medical) associated with Insulin Degludec / Insulin Aspart

01 Dec 2024·Diabetes Therapy

Switching from Premixed Insulin to Insulin Degludec/Insulin Aspart for the Management of Type 2 Diabetes Mellitus: Implications of a Real-World Study on Insulin Degludec Dosing

Article

Author: Wu, Yiming ; Li, Ang ; Zhang, Junqing

INTRODUCTION:

When switching from premixed insulin to insulin degludec/aspart (IDegAsp), IDegAsp usually starts at the same dose as the premixed insulin according to limited clinical experience or at a dose according to clinician discretion. The dose of insulin degludec used in the real world after switching has been poorly investigated.

METHODS:

A retrospective analysis was conducted on patients with type 2 diabetes who switched from premixed insulin to IDegAsp from October 2016 to December 2023. Repeated measures analysis of variance was used to compare changes in insulin dose, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and postprandial blood glucose (PBG) before and after switching.

RESULTS:

Sixty-six patients with prior low-ratio premixed insulin and 22 with prior mid-ratio premixed insulin were included. Among the low-ratio insulin users, the total daily dose of insulin degludec (IDeg) decreased by 21.43% and 19.05% at 3 and 6 months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). Conversely, among mid-ratio insulin users, the IDeg daily dose increased by 10.71% and 32.14% at 3 and 6 months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). In all patients, HbA1c levels decreased by 0.70%, FBG decreased by 1.00 mmol/l, and PBG decreased by 1.61 mmol/l after 6 months of switching (all p < 0.05); the total daily insulin dose and injection frequency significantly decreased after switching (both p < 0.05); age and disease duration did not affect IDegAsp effects on HbA1c reduction.

CONCLUSIONS:

In the setting of transition to IDegAsp from premixed insulin, the dose of basal insulin in the premixed formulation can be a valuable reference for adjusting insulin degludec dose. IDegAsp is superior to premixed insulin in blood glucose control with reduced total daily dose and injection frequency. IDegAsp could be the best choice for the management of diabetes in elderly patients.

08 Nov 2024·MEDICINE

Survey of fear and compliance of Insulin Degludec and Insulin Aspart injection in type 2 diabetes mellitus patients and analysis of influencing factors

Article

Author: Xie, Min ; Chen, Sisi ; He, Qiqiang

This study aims to investigate the fear and compliance of Insulin Degludec and Insulin Aspart (IDegAsp) injection in type 2 diabetes mellitus (T2DM) patients and study the factors influencing patient compliance. A total of 120 patients with T2DM treated from February 2019 to March 2022 were investigated and analyzed for fear and compliance on the Diabetes Fear of Injecting and Self-testing Questionnaire of diabetic patients and were divided into compliance and noncompliance groups according to the results to analyze the factors affecting patient compliance. The study found a high level of fear of IDegAsp injection among the 120 T2DM patients, with an average Diabetes Fear of Injecting and Self-testing Questionnaire score of (39.19 ± 4.59) points. Scores for medication compliance, dietary compliance, blood sugar monitoring, and lifestyle changes were (10.48 ± 1.52) points, (12.18 ± 2.27) points, (0.84 ± 0.12) points, and (9.13 ± 2.21) points, respectively. There was no significant difference between the compliance and noncompliance groups in terms of gender, age, lifestyle, educational level, occupation, current treatment method, family monthly income per capita, and medical payment method (P > .05). However, there were significant differences influenced by disease duration, complications, cognitive level, self-efficacy level, comorbidity count, and living status (P < .05). Multifactorial analysis showed that educational level, disease duration, complications, cognitive level, self-efficacy level, comorbidity count, and living status all affected patient compliance (P < .05). Educational level, disease duration, complications, cognitive level, self-efficacy level, comorbidity count, and living status are important factors affecting the fear and treatment compliance of IDegAsp injection in T2DM patients. These findings have implications for improving patient compliance and alleviating treatment fear.

01 Oct 2024·INTERNAL MEDICINE JOURNAL

Initiating or switching to insulin degludec/insulin aspart in a real‐world population of adults with type 2 diabetes in Australia: results from a prospective, non‐interventional study

Article

Author: Roberts, Anthony ; Moses, Robert ; Glastras, Sarah J. ; Cohen, Neale D. ; Fulcher, Gregory R. ; Mah, Peak M. ; McCallum, Roland W. ; Davies, Katherine ; Thong, Ken Y. ; d'Emden, Michael

Abstract:

Background:

Insulin degludec/insulin aspart (IDegAsp) is a fixed‐ratio co‐formulation of insulin degludec and insulin aspart for the treatment of people with diabetes and suboptimal glycaemic control. Few real‐world studies of IDegAsp treatment have been conducted. Here, we report results from the Australian cohort of the global ARISE study of real‐world IDegAsp use.

Aims:

To investigate glycaemic control and other clinical outcomes in people with type 2 diabetes (T2D) treated with IDegAsp in a real‐world setting in Australia.

Methods:

A total of 183 adults with T2D initiating or switching to IDegAsp in the Australian cohort of the open‐label, non‐interventional ARISE study were followed for 26–36 weeks from August 2019 to December 2020.

Results:

IDegAsp was associated with significant reductions from baseline to end of study (EOS) in mean glycated haemoglobin (estimated change −0.8% (95% confidence interval (CI): −1.05 to −0.56; P < 0.0001)), fasting plasma glucose (−1.6 mmol/L (95% CI: −2.49 to −0.63; P = 0.0017)) and body weight (−2.6 kg (95% CI: −3.68 to −1.55; P < 0.0001)). In insulin‐experienced patients, the mean total daily insulin dose did not change significantly (estimated change from baseline to EOS 3.8 (95% CI: –3.70 to 11.21; P = 0.3202)). The proportion of patients experiencing hypoglycaemia numerically decreased during the study (non‐severe: 14.2–10.9%; nocturnal non‐severe: 4.9–2.2%; and severe: 2.2–0%).

Conclusions:

Initiating or switching to IDegAsp in a real‐world population of people with T2D in Australia was associated with significant improvements in glycaemic control and body weight, and numerically lower levels of hypoglycaemia compared with baseline.

News (Medical) associated with Insulin Degludec / Insulin Aspart

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.libproxy1.nus.edu.sg/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

22 Jun 2024

·www.prnewswire.com

Gan & Lee Pharmaceuticals Announces Significant Progress on New Diabetes and Obesity Treatments at the American Diabetes Association's 84th Scientific Sessions

BEIJING and BRIDGEWATER, N.J., June 22, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the results of the Phase 1b/2a clinical study of the Company's independently developed glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18 Injection, in an obese/overweight population in China, along with the results of two other innovative insulins' preclinical studies in poster presentations at the American Diabetes Association's（ADA's）84th Scientific Sessions. This randomized, double-blind, placebo-controlled, dose-escalation Phase 1b/2a clinical study evaluated the safety, tolerability, pharmacokinetics and efficacy of GZR18 Injection in Chinese subjects with obesity/overweight after multiple administration on a once-weekly (QW) or bi-weekly (Q2W) dosing interval. A total of 36 obese participants were enrolled in the study and randomized in a 3:1 ratio to receive a dose titration of 1.5 mg to 30 mg of GZR18 Injection or a matching placebo for a total of 35 weeks. The study results demonstrated a superior efficacy of GZR18 Injection than placebo for weight reduction in Chinese obese subjects. After 35 weeks of treatment, the mean weight change from baseline in the GZR18 QW group was -16.5 kg (95% CI: -19.9 kg, -13.1 kg); the placebo-adjusted mean percent weight change from baseline was -18.6% (95% CI: -25.5%, -11.6%). Although it was not a head-to-head study, when compared to the published data on weight reduction of similar products currently available on the market, GZR18's weight-reducing ability outperformed Semaglutide and dual-incretin receptor targeted Tirzepatide in similar study duration. Meanwhile, the mean weight change from baseline in the GZR18 Q2W group was -11.3 kg (95% CI: -15.4 kg, -7.2 kg); the placebo-adjusted mean percent weight change from baseline was -13.5% (95% CI: -21.0%, -6.0%). In addition, the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 100.0%, 90.0%, and 80.0%, respectively, in the GZR18 QW group, and the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline were 71.4%, 71.4%, and 42.9%, respectively, in the GZR18 Q2W group. No participant in the placebo group achieved a weight reduction of 5% and above. In terms of safety, GZR18 Injection was well tolerated in obese participants. The most commonly reported adverse events (AE) during treatment were gastrointestinal related AEs, and all were mild to moderate in severity. This is consistent with the incretin-based therapies approved for the treatment of obesity and overweight and occurred mainly in the early dose-escalation period. There were no serious hypoglycemic events in this study and no serious adverse events related to the investigational drug. Gan & Lee also announced that a multi-center, placebo-controlled, randomized, double-blind, 30-week Phase 2 clinical study evaluating the efficacy and safety of GZR18 Injection in Chinese adults with obesity and overweight is in progress. A total of 338 adults with obesity or overweight were enrolled in this study, and the study explores a broader dose range and frequency of administration. The main body of the Phase 2 has now been completed, and the priliminary study data further support the results of the reported Phase 1b/2a obese/overweight study, particularly the positive results achieved with bi-weekly dosing frequency. "We are very excited about the clinical results of the GZR18 program to the present day." Dr. Gan Zhong-ru, Founder of Gan & Lee, commented. "Our unique molecular design delays the onset of drug action and attenuates the peak effect, thereby improving drug tolerability and achieving smooth and sustained weight loss in a stepwise manner. Moreover, GZR18 has a longer duration of action, which is expected to be administered once every two weeks. Meanwhile, we hope that the clinical results of GZR18 will provide more evidence to reveal the mechanism of action of different targets of Incretins and Glucagon." In addition, Gan & Lee announced the results of preclinical trials of the company's investigational products: GZR4, a once-weekly insulin analog, and GZR101, a premixed dual insulin analog, at the ADA's 84th Scientific Sessions: Once-weekly Insulin Analog GZR4 GZR4 is a novel ultra-long-acting basal insulin analog designed for once-weekly administration. Results from preclinical studies have shown that GZR4 has a significantly higher affinity for human serum albumin (HSA) and a significantly lower affinity for the insulin receptor than insulin Icodec, another once-weekly insulin analog. Moreover, unlike insulin Icodec, GZR4 maintains its activity in activating the insulin receptor after binding to albumin. In the studies using animal models of diabetes, the glucose-lowering effect of GZR4 was observed to be 2-3 times greater than that of insulin Icodec. Based on the preclinical results, GZR4 is expected to be the fourth-generation basal insulin that can be administered once a week to achieve an effective glycemic control. Premixed Insulin Analog GZR101 GZR101 injection is a premixed insulin analog made from a combination of ultra-long-acting basal insulin GZR33 injection and rapid-acting insulin aspart (Rapilin®). Different from traditional premixed insulin analogs, the duration of glucose-lowering effect of basal insulin component (GZR33) in GZR101 can last 72 hours, and there is no significant peak within 24 hours after reaching a steady state with multiple injections. When combined with insulin aspart (Rapilin®️) to make a premixed insulin analog, it can achieve smooth control of fasting and postprandial blood glucose throughout the day. In diabetic animal models, GZR101 is significantly superior than insulin degludec/insulin aspart (IDegAsp) in blood glucose reduction and safety. As a premixed insulin analog developed based on an advanced concept, GZR101 is expected to make an important contribution to the control of blood glucose and the reduction of the risk of hypoglycemia in patients with diabetes globally. Conclusions and Future Directions The ADA's 84th scientific sessions highlighted Gan & Lee Pharmaceuticals' leadership in developing next-generation diabetes and obesity treatments. With these latest preclinical and clinical results, the Company will continue to advance the development of innovative therapeutics for diabetes. While ongoing studies and upcoming trials will further support the positive influence of these innovative medicines on public health issues related to diabetes and obesity. Forward-looking Statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. References ： American Diabetes Association. ADA's 84th Scientific Sessions. 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 second overall and first among domestic 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: [email protected] (Media) [email protected] (Business Development) SOURCE Gan & Lee Pharmaceuticals

Clinical ResultPhase 2Drug Approval

100 Deals associated with Insulin Degludec / Insulin Aspart

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	IS	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	LI	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	NO	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus, Type 1	JP	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	AU	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	DK	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	FI	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	IN	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	MY	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	PL	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	SE	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	TW	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	TH	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	TR	Novo Nordisk A/S	05 Nov 2009

Clinical Result

Indication

Phase

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	wgzzulhhcl(hfmsgvjiea) = vzkhekakkx assphluxad (gogboxbejt, 0.40 ± 0.17 U/kg)	Positive	14 Jun 2024
				Insulin Glargine	wgzzulhhcl(hfmsgvjiea) = huvnnetgyy assphluxad (gogboxbejt, 0.39 ± 0.18 U/kg)
NCT05221580 (19-PUB, ADA2024)	Not Applicable	Diabetes Mellitus, Type 2	878	Insulin Degludec/Insulin Aspart (IDegAsp)	xnfbvudobf(gjyrhzhnog) = bqeqbgoqdv hqodykpkhj (yoxpvlokca, -1.36 to -1.19) View more	Positive	14 Jun 2024
ADA2022	Not Applicable	-	535	IDegAsp	aihorvhuft(jbtyxbjowx) = gqusgmwuiw qoejrankpg (ggclfurimj ) View more	-	01 Jun 2022
NCT02821052 (Pubmed \| Adv Ther)	Not Applicable	Diabetes Mellitus	1,321	Insulin Degludec/Insulin Aspart	pvoivgpiky(ljsmunovxo) = aapgutotrw mahosxqgkm (pupcpaqexi, 3.4 - 5.8) View more	-	20 Nov 2021
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	324	Once-daily IDegAsp	lnayhpspyn(ddmbegwzrz) = omhzdaknhh cvkxpfprjv (xdsmfjinnk ) View more	-	01 Jun 2021
				Basal insulin	lnayhpspyn(ddmbegwzrz) = zaoilwvfse cvkxpfprjv (xdsmfjinnk ) View more
NCT02762578 (BOOST, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	543	insulin degludec/insulin aspart	mnxnzekooi(fpujfzzvdf) = Non-inferiority for change from baseline to week 26 in HbA1c bvspmtzhnz (fpvxleqooa ) 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	hzugfegsaa(yiqfirqhxa) = similar for IDegAsp versus BIAsp 30 tqxrzpiwzv (rpumslkeuz ) View more	-	01 Feb 2019
				BIAsp 30
NCT02762578 (BOOST, CTgov)	Phase 3	Diabetes Mellitus, Type 2	543	insulin degludec/insulin aspart (IDegAsp BID)	vvjtkyiseq(sdfwobkbex) = obahlrtgcv trggwupoed (cblvlchhlz, knwnijitxn - baqjyrjowm) View more	-	07 Dec 2018
				biphasic insulin aspart (BIAsp 30 BID)	vvjtkyiseq(sdfwobkbex) = rcexebrcya trggwupoed (cblvlchhlz, yjswoponui - nhzujdwgkb) View more
NCT01835431 (Pubmed \| Pediatr Diabetes) Manual	Phase 3	Diabetes Mellitus, Type 1	362	insulin degludec/insulin aspart	qokcelczjb(nlconaldkb) = zhaswyfzav gmojwdgwcx (tgkyzbutrh )	Non-inferior	01 Nov 2018
				Insulin detemir+insulin aspart	qokcelczjb(nlconaldkb) = fmtnxwltfj gmojwdgwcx (tgkyzbutrh )
NCT02906917 (EASD2018)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp QD	dhdimfcumv(xewoalvjvh) = xcnkxnwffx lpgwuemmqf (tzdhngddwz ) View more	Positive	04 Oct 2018
				Glargine U100 QD + IAsp QD	dhdimfcumv(xewoalvjvh) = rjcxmtqrym lpgwuemmqf (tzdhngddwz ) View more

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