A Double-Blind, Randomized, Single Center, two-Sequence, four-Period, Two treatment Crossover Glucose Clamp Study to Evaluate Pharmacokinetics and Pharmacodynamics Following Two Single Subcutaneous Doses of Insulin Glargine Injection with LantusÂ® Injection in Healthy Subjects.

Start Date30 Jun 2015

Sponsor / Collaborator

Wockhardt Bio AG

CTR20140607 / CompletedPhase 3

多中心、随机、开放、平行组、阳性药对照、III期临床研究评价甘精胰岛素注射液治疗2型糖尿病的有效性和安全性

[Translation] A multicenter, randomized, open, parallel-group, active-control, phase III clinical study to evaluate the efficacy and safety of insulin glargine injection in the treatment of type 2 diabetes

以阳性药为对照评价试验药物甘精胰岛素注射液治疗2型糖尿病的有效性和安全性

[Translation]

Evaluation of the efficacy and safety of the experimental drug insulin glargine injection in the treatment of type 2 diabetes using a positive drug as a control

Start Date14 Nov 2014

Sponsor / Collaborator

Tonghua Dongbao Pharmaceutical Co., Ltd.

100 Clinical Results associated with Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

100 Translational Medicine associated with Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

100 Patents (Medical) associated with Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

323

Literatures (Medical) associated with Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

01 May 2024·Current Diabetes Reviews

Real-world Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Mellitus During the Period of Ramadan in Four Countries (Egypt, Jordan, Lebanon, and Turkey): A Prospective Observational Study

Article

Author: Annabi, Firas ; Shaltout, Inass ; Shereen, Mark ; Malek, Rachid ; Assaad Khalil, Samir ; Ballout, Hajar ; Hassanein, Mohamed

Aim:This non-interventional observational study aimed to describe the clinical outcomes of patients with T2DM treated with Gla-300 during the period of Ramadan.Background:Type 2 diabetes mellitus (T2DM) patients who decide to fast during the holy month of Ramadan face several challenges in achieving glycemic control without increasing the risk of hypoglycemia. Insulin glargine-300 (Gla-300) has well-established safety and efficacy in improving glycemic control in multiple randomized clinical trials (RCTs). However, limited evidence is available regarding its safety and effectiveness during fasting.Objective:The objective of this study was to assess the safety and clinical outcomes of insulin glargine-300 (Gla-300) in T2DM patients before, during, and after Ramadan.Methods:We conducted a prospective, observational, non-comparative, multicenter study on patients with T2DM currently treated with Gla-300 who planned to fast and continue on Gla-300 during Ramadan in four countries (Egypt, Jordan, Lebanon, and Turkey). The study outcomes included the change in glycemic parameters and incidence of hypoglycemia before, during, and after Ramadan.Results:One hundred and forty T2DM patients were included. Nearly 61% of the included patients had a duration of diabetes of <10 years. The mean Gla-300 daily doses during the pre-Ramadan, Ramadan, and post-Ramadan periods were 22.2 ±7.4, 20.4 ±7.5, and 22.5 ±4.7 IU, respectively. The mean change values from pre-Ramadan to Ramadan and post-Ramadan were -1.7 ±6.9 IU and 0.5 ±4.7 IU, respectively, among the included patients. The mean HbA1c decreased during the study period initiating from 7.9 ±1.4% pre-Ramadan to 6.9 ±0.4% post-Ramadan. The overall HBA1c target value was 6.9 ±0.4%, while the HbA1c target was achieved by 29 patients (21.9%). The mean fasting blood glucose (FPG) showed a reduction from baseline value in the post-Ramadan period by -0.9 ±2.3mmol/L. Five patients (3.57%) had symptomatic documented hypoglycemia during Ramadan, and none was considered to have severe hypoglycemia.Conclusion:Our study showed that insulin Gla-300 maintained the glycemic control of T2DM patients who decided to fast during the holy month of Ramadan without increasing the risk of hypoglycemia. Regular self-monitoring of blood glucose levels during Ramadan is highly recommended to avoid possible complications.

01 Jan 2024·Current Diabetes Reviews

Insulin Glargine in Type 1 Diabetes Mellitus: A Review of Clinical Trials and Real-world Evidence Across Two Decades

Review

Author: Prasannakumar, K M ; Rai, Madhukar ; Kochar, I P S ; Chandalia, Hemraj ; Saboo, Banshi ; Bantwal, Ganapathi ; Sarda, Archana ; Mehrotra, R N ; Kesavadev, Jothydev ; Ghosh, Sujoy

Background:Over the past two decades, insulin glargine 100 U/mL (Gla-100) has emerged as the “standard of care” basal insulin for the management of type 1 diabetes mellitus (T1DM). Both formulations, insulin glargine 100 U/mL (Gla-100) and glargine 300 U/mL (Gla- 300) have been extensively studied against various comparator basal insulins across various clinical and real-world studies. In this comprehensive article, we reviewed the evidence on both insulin glargine formulations in T1DM across clinical trials and real-world studies.Methods:Evidence in T1DM for Gla-100 and Gla-300 since their approvals in 2000 and 2015, respectively, were reviewed.Results:Gla-100 when compared to the second-generation basal insulins, Gla-300 and IDeg-100, demonstrated a comparable risk of overall hypoglycemia, but the risk of nocturnal hypoglycemia was higher with Gla-100. Additional benefits of Gla-300 over Gla-100 include a prolonged (>24- hours) duration of action, a more stable glucose-lowering profile, improved treatment satisfaction, and greater flexibility in the dose administration timing.Conclusion:Both glargine formulations are largely comparable to other basal insulins in terms of glucose-lowering properties in T1DM. Further, risk of hypoglycemia is lower with Gla-100 than Neutral Protamine Hagedorn but comparable to insulin detemir.

03 Aug 2023·Expert Opinion on Biological Therapy

Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective

Article

Author: Raj, Praveen ; Joshi, Shashank R ; Mittra, Shivani ; Suvarna, Viraj Ramesh ; Athalye, Sandeep N

INTRODUCTIONFor many of the 537 million adults living now with diabetes, the cost of insulin is becoming prohibitive as the insulin prices have tripled between 2002-2013. Globally, the direct annual cost of healthcare expenditure due to diabetes will soon be US$1 Trillion. Biosimilars provide access to high-quality, affordable biologic therapy that is otherwise inaccessible due to the high costs of original biologics.AREAS COVEREDA primer to the development of biosimilars shows comparable structural and analytical characterization to the original biologics (e.g. insulins), with no clinically significant or meaningful differences in efficacy and safety. 'Interchangeability' status, a regulatory designation by the US FDA, bestowed to some biosimilars, enables confidence in high-quality, bio-equivalent biosimilar of insulin with key global approvals. This can allow rapid uptake of biosimilars by the prescribers, formulary decision-makers, and payors. Biocon-Viatris's biosimilar Insulin Glargine (Semglee®) is the first interchangeable biosimilar insulin approved by the US FDA.EXPERT OPINIONThe 'interchangeable' status can prompt faster and wider uptake of insulin biosimilars and keep the insulin expenditure under control, especially for patients who otherwise practice non-adherence or rationing of life-saving insulin. Education, support, and awareness can ensure that interchangeable biosimilars gain wider acceptance.

News (Medical) associated with Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

30 Nov 2023

·www.prnewswire.com

Biocon Biologics Successfully Completes Integration of Viatris' Biosimilar Business in 31 Countries in Europe

BENGALURU, India, Nov. 30, 2023 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the integration of the Viatris' biosimilars business in 31 European countries has been successfully completed. Following the acquisition of substantially all of the global biosimilar business of Viatris in November 2022, and the related integration of over 70 emerging market countries in July 2023 and North America in September 2023, the full transition of Viatris' biosimilars operations to Biocon Biologics Ltd in Europe represents another significant milestone as a world-leading biosimilars company. In Europe, Biocon Biologics portfolio includes 7 biosimilars: Insulin Aspart and Insulin Glargine, Bevacizumab, Pegfilgrastim, Trastuzumab, Adalimumab, and Etanercept. At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, ophthalmology, and bone health. Serving over 5.7M patients annually, the Company is committed to providing access to high-quality therapies and solutions to patients, healthcare systems and governments across the globe. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "The integration of the Viatris' biosimilar business in Europe ahead of schedule is another important milestone for Biocon Biologics in our journey as a global biosimilars leader. We are pleased to expand access to life-saving treatments for patients across Europe. Our unique, fully integrated capabilities and robust pipeline of 20 products will allows us to better address patient needs and be a reliable partner to health organisations. " Jozef Belcik, Head of Commercial Europe & JANZ, Biocon Biologics Ltd, said: "We are extremely pleased to have reached this historic moment and we are proud to lead the way in the advancement of biosimilars. As we continue to drive innovation and invest in the future, our mission is singularly focused on the development, manufacturing, distribution, and commercialization of biosimilars in Europe and in the world. " After the acquisition from Viatris, Biocon Biologics and its partners will commercialize biosimilar products in the following countries: Albania, Austria, Belgium, Bosnia, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, and The United Kingdom. Note about biosimilars: Based on IQVIA White Paper "The impact of biosimilar competition in Europe, IQVIA (2022)", as of 2022, the cumulative savings at list prices from the impact of biosimilar competition in Europe reached over €30 billion. Furthermore, since the launch of biosimilars these provided nearly 4.5 billion patient treatment days to European patients. Source: 1-The impact of biosimilar competition in Europe, IQVIA (2022) December 2022. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. BBL has acquired substantially all of the global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on LinkedIn: Biocon Biologics ; Twitter: @BioconBiologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on Linked In: Biocon Limited; Twitter: @bioconlimited for company updates. Forward -Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd.

AcquisitionImmunotherapyBiosimilar

100 Deals associated with Insulin glargine biosimilar(Tonghua Dongbao Pharmaceutical Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE04	DB00047

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus	CN	Tonghua Dongbao Pharmaceutical Co., Ltd.	06 Dec 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Endocr Pract	Not Applicable	Diabetes Mellitus, Type 2	280	Biphasic Insulin Aspart 70/30 + metformin	sarmkvyxuy(qzufmimdog) = pwjqrabvfo wzahvvoilz (wqibunoviq ) View more	-	01 Jan 2011
				Insulin Glargine + metformin + secretagogues	sarmkvyxuy(qzufmimdog) = kbnscjynmg wzahvvoilz (wqibunoviq ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis