An Open-label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy, and Safety of Gan & Lee Insulin Lispro Injection to Humalog in Adult Subjects With Type 1 Diabetes Mellitus (T1DM)

Primary Objective:
• To compare the immunogenicity of Gan & Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM
Secondary Objectives:
To evaluate the safety of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM
To evaluate the efficacy of Gan & Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM

Start Date04 Dec 2019

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

NCT04235439 / CompletedPhase 1

A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Lispro Injection With Both EU - Approved and US - Licensed Humalog® in Healthy Male Subjects

Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin lispro preparations
To evaluate the single dose safety and local tolerability of the three insulin lispro preparations

Start Date23 Apr 2019

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

CTR20181640 / Active, not recruitingPhase 1

单中心、随机、开放、以进口同类产品（优泌乐）为交叉对照，评价速秀霖对健康受试者的生物等效和安全性

[Translation] A single-center, randomized, open-label study was conducted to evaluate the bioequivalence and safety of Suxiulin in healthy subjects using an imported similar product (Humalog) as a crossover control.

通过单中心、随机、开放、两次交叉的正常葡萄糖钳夹试验，评价速秀霖与进口同类产品（优泌乐），在健康受试者参与试验下的生物等效性和安全性，为中国的临床医生补充此领域空白，同时为海外药品注册提供了亚洲健康人群可参考数据。

[Translation]

Through a single-center, randomized, open, double-crossover normal glucose clamp study, the bioequivalence and safety of Suxiulin and a similar imported product (Humalog) were evaluated with the participation of healthy subjects. This will fill the gap in this field for Chinese clinicians and provide reference data for healthy Asian populations for overseas drug registration.

Start Date25 Nov 2014

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Translational Medicine associated with Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Patents (Medical) associated with Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

115

Literatures (Medical) associated with Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

01 Sep 2024·Diabetes Technology & Therapeutics

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes

Article

Author: DiMeglio, Linda A. ; Aleppo, Grazia ; Hughes, Michael S. ; Bailey, Ryan ; Daniels, Mark ; Levy, Carol J. ; Shah, Viral N. ; Bruggeman, Brittany ; Beck, Roy W. ; Pinsker, Jordan E. ; Bhargava, Anuj ; Calhoun, Peter ; Laffel, Lori M. ; Kipnes, Mark ; Pollom, Robyn ; Rodriguez, Henry ; Lum, John W. ; Forlenza, Gregory ; Clements, Mark A. ; Brown, Sue A. ; Sasson-Katchalski, Ravid

Objective: To evaluate the safety and explore the efficacy of use of ultra-rapid lispro (URLi, Lyumjev) insulin in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology in children, teenagers, and adults living with type 1 diabetes (T1D). Methods: At 14 U.S. diabetes centers, youth and adults with T1D completed a 16-day lead-in period using lispro in a t:slim X2 insulin pump with Control-IQ 1.5 technology, followed by a 13-week period in which URLi insulin was used in the pump. Results: The trial included 179 individuals with T1D (age 6-75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed to override boluses or a missed meal. No diabetic ketoacidosis events occurred. Two participants stopped URLi use because of infusion-site discomfort, and one stopped after developing a rash. Mean time 70-180 mg/dL increased from 65% ± 15% with lispro to 67% ± 13% with URLi (P = 0.004). Mean insulin treatment satisfaction questionnaire score improved from 75 ± 13 at screening to 80 ± 11 after 13 weeks of URLi use (mean difference = 6; 95% confidence interval 4-8; P < 0.001), with the greatest improvement reported for confidence avoiding symptoms of high blood sugar. Mean treatment-related impact measure-diabetes score improved from 74 ± 12 to 80 ± 12 (P < 0.001), and mean TRIM-Diabetes Device (score improved from 82 ± 11 to 86 ± 12 (P < 0.001). Conclusions: URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants. Clinicaltrials.gov registration: NCT05403502.

17 Jul 2024·Cureus

Sub-massive Pulmonary Embolism and New-Onset Diabetes Mellitus

Article

Author: Fonarov, Ilya ; Casadesus, Damian ; Rama, Sapna

Pulmonary embolism (PE) is a life-threatening disease with variable clinical signs and symptoms, and the diagnosis often requires a high index of suspicion. Patients can have a variety of risk factors that predispose them to venous thromboembolic (VTE) disease. This is a case of a female who presented to the emergency room with new-onset fatigue and shortness of breath for five days. The patient was diagnosed with a sub-massive PE with high-risk features. The patient was also hyperglycemic and diagnosed with new-onset diabetes mellitus. For the PE, she was treated with systemic thrombolysis followed by a standard oral factor Xa inhibitor; for her new onset of diabetes, the patient was started on glargine and lispro insulin. This case underscores the importance of comprehensive management for patients with PE and concurrent metabolic conditions.

01 Mar 2023·Veterinary medicine and science

Long‐term field study of lispro and neutral protamine Hagedorn insulins treatment in dogs with diabetes mellitus

Article

Author: Mazaki‐Tovi, Michal ; Hess, Rebecka S. ; Hershkovitz, Shai ; Kuzi, Sharon ; Yas, Einat

Abstract:

Background:

The long‐term clinical and biofhemical effects of basal‐bolus insulin treatment with lispro and NPH in dogs with diabetes mellitus are undocumented.

Objectives:

To perform a prospective pilot field study of the long‐term effects of lispro and NPH on clinical signs and serum fructosamine concentrations (SFC) in dogs with diabetes mellitus.

Methods:

Twelve dogs received combined lispro and NPH insulins treatment twice a day and were examined every 2 weeks for 2 months (visits 1–4), and every 4 weeks for up to 4 additional months (visits 5–8). Clinical signs and SFC were recorded at each visit. Polyuria and polydipsia (PU/PD) were scored as absent (0) or present (1).

Results:

Median (range) PU/PD scores of combined visits 5–8 (0, 0–1) were significantly lower than median scores of combined visits 1–4 (1, 0–1, p = 0.03) and at enrolment (1, 0–1, p = 0.045). Median (range) SFC of combined visits 5–8 (512 mmol/L, 401–974 mmol/L) was significantly lower than SFC of combined visits 1–4 (578 mmol/L, 302–996 mmol/L, p = 0.002) and at enrolment (662 mmol/L, 450–990 mmol/L, p = 0.03). Lispro insulin dose was significantly and negatively, albeit weakly, correlated with SFC concentration during visits 1 through 8 (r = –0.3, p = 0.013). Median duration of follow up was 6 months (range 0.5–6) and most dogs (8, 66.7%) were followed for 6 months. Four dogs withdrew from the study within 0.5–5 months because of documented or suspected hypoglycaemia, short NPH duration or sudden unexplained death. Hypoglycaemia was noted in 6 dogs.

Conclusions:

Long‐term lispro and NPH combination therapy may improve clinical and biochemical control of some diabetic dogs with comorbidities. Risk of hypoglycaemia should be addressed with close monitoring.

News (Medical) associated with Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

23 Aug 2022

·www.prnewswire.com

$9.3 Billion Worldwide Rapid Acting Insulin Industry to 2027 - Featuring Adocia, Biocon Limited and Geropharm Among Others

DUBLIN, Aug. 23, 2022 /PRNewswire/ -- The "Rapid Acting Insulin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global rapid acting insulin market size reached US$ 7 Billion in 2021. Looking forward, the publisher expects the market to reach US$ 9.3 Billion by 2027, exhibiting a CAGR of 4.85% during 2021-2027. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic. These insights are included in the report as a major market contributor. Rapid acting insulin is a medication used to control glucose levels in patients with diabetes. It is either inhaled or administered into the bloodstream with a syringe, a pre-filled pen, or an insulin pump. It is taken prior to meals and snacks to bring overly high blood glucose to a normal level and surge the level of bolus insulin. At present, new insulin formulations like novel ultra-paid-acting insulins that enhance absorption are considered a suitable option for people who cannot achieve postprandial glycemic targets with other bolus insulins. Diabetes mellitus (DM) and poorly controlled blood glucose can increase the risk of mortality and severity among patients with coronavirus disease (COVID-19). This represents one of the key factors fueling the need for rapid acting insulins to monitor blood glucose levels. Apart from this, the growing prevalence of type 1 diabetes on account of exposure to viruses and other environmental factors and low levels of vitamin D acts as another factor propelling the demand for rapid acting insulins across the globe. This can also be attributed to the increasing instances of neonatal jaundice in newborns, in confluence with improving diagnostic modalities. In addition to this, as the risk of developing diabetes increases with age, the rising global geriatric population is facilitating the market growth. Furthermore, leading market players are introducing ready-to-use rapid acting insulin kits that are fast, accessible in vials and a pen presentation, and help enhance glycemic control in both adults and children. These players are also focusing on mergers and acquisitions (M&A), which is anticipated to contribute to the development of new-generation product variants. Competitive Landscape: The competitive landscape of the industry has also been examined along with the profiles of the key players being Adocia, Biocon Limited, Eli Lilly and Company, Gan & Lee Pharmaceuticals Co. Ltd., Geropharm, MannKind Corporation, Merck & Co. Inc., Novo Nordisk A/S, Sanofi S.A., and Wockhardt Ltd. Key Questions Answered in This Report: How has the global rapid acting insulin market performed so far and how will it perform in the coming years? What has been the impact of COVID-19 on the global rapid acting insulin market? What are the key regional markets? What is the breakup of the market based on the product? What is the breakup of the market based on the indication? What is the breakup of the market based on the distribution channel? What are the various stages in the value chain of the industry? What are the key driving factors and challenges in the industry? What is the structure of the global rapid acting insulin market and who are the key players? What is the degree of competition in the industry? Key Topics Covered: 1 Preface 2 Scope and Methodology 3 Executive Summary 4 Introduction 4.1 Overview 4.2 Key Industry Trends 5 Global Rapid Acting Insulin Market 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Forecast 6 Market Breakup by Product 6.1 Lispro Insulin 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 Aspart Insulin 6.2.1 Market Trends 6.2.2 Market Forecast 6.3 Glulisine Insulin 6.3.1 Market Trends 6.3.2 Market Forecast 7 Market Breakup by Indication 7.1 Type 1 Diabetes 7.1.1 Market Trends 7.1.2 Market Forecast 7.2 Type 2 Diabetes 7.2.1 Market Trends 7.2.2 Market Forecast 8 Market Breakup by Distribution Channel 8.1 Hospital Pharmacies 8.1.1 Market Trends 8.1.2 Market Forecast 8.2 Drug Stores and Retail Pharmacies 8.2.1 Market Trends 8.2.2 Market Forecast 8.3 Online Stores 8.3.1 Market Trends 8.3.2 Market Forecast 9 Market Breakup by Region 10 SWOT Analysis 11 Value Chain Analysis 12 Porters Five Forces Analysis 13 Price Analysis 14 Competitive Landscape 14.1 Market Structure 14.2 Key Players 14.3 Profiles of Key Players 14.3.1 Adocia 14.3.1.1 Company Overview 14.3.1.2 Product Portfolio 14.3.1.3 Financials 14.3.2 Biocon Limited 14.3.2.1 Company Overview 14.3.2.2 Product Portfolio 14.3.2.3 Financials 14.3.2.4 SWOT Analysis 14.3.3 Eli Lilly and Company 14.3.3.1 Company Overview 14.3.3.2 Product Portfolio 14.3.3.3 Financials 14.3.3.4 SWOT Analysis 14.3.4 Gan & Lee Pharmaceuticals Co. Ltd. 14.3.4.1 Company Overview 14.3.4.2 Product Portfolio 14.3.4.3 Financials 14.3.5 Geropharm 14.3.5.1 Company Overview 14.3.5.2 Product Portfolio 14.3.6 MannKind Corporation 14.3.6.1 Company Overview 14.3.6.2 Product Portfolio 14.3.6.3 Financials 14.3.6.4 SWOT Analysis 14.3.7 Merck & Co. Inc. 14.3.7.1 Company Overview 14.3.7.2 Product Portfolio 14.3.7.3 Financials 14.3.7.4 SWOT Analysis 14.3.8 Novo Nordisk A/S 14.3.8.1 Company Overview 14.3.8.2 Product Portfolio 14.3.8.3 Financials 14.3.8.4 SWOT Analysis 14.3.9 Sanofi S.A. 14.3.9.1 Company Overview 14.3.9.2 Product Portfolio 14.3.9.3 Financials 14.3.9.4 SWOT Analysis 14.3.10 Wockhardt Ltd. 14.3.10.1 Company Overview 14.3.10.2 Product Portfolio 14.3.10.3 Financials For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Acquisition

100 Deals associated with Recombinant lispro insulin biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Gan & Lee Pharmaceuticals Co., Ltd.	19 Jan 2006

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