The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?

Start Date01 Dec 2025

Sponsor / Collaborator

Eastern Virginia Medical School

CTIS2025-521748-39-00

/ RecruitingPhase 4IIT

SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy

Start Date14 Nov 2025

Sponsor / Collaborator

Universita Cattolica Del Sacro Cuore

NCT07117240

/ Enrolling by invitationPhase 4IIT

Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of GLP-1 Receptor Agonist Plus Basal Insulin With Intensive Insulin Therapy

Glucocorticoids are commonly used in the treatment of autoimmune, inflammatory, and neoplastic diseases. Despite their therapeutic efficacy, they are associated with significant metabolic side effects. In the proposed research, the aim is to assess the metabolic efficacy and safety of fixed-ratio combination therapy (basal insulin + GLP-1 receptor agonist) compared to standard insulin therapy in patients with SID. In a selected group of patients, a randomised clinical trial would be conducted to assess the potential benefits of GLP-1 receptor agonists in the management of SID.

Start Date10 Jul 2025

Sponsor / Collaborator

Warszawski Uniwersytet Medyczny

100 Clinical Results associated with Insulin Glargine(Mylan Nv)

100 Translational Medicine associated with Insulin Glargine(Mylan Nv)

100 Patents (Medical) associated with Insulin Glargine(Mylan Nv)

306

Literatures (Medical) associated with Insulin Glargine(Mylan Nv)

01 Oct 2025·DIABETES

Predictors of Initial and Sustained Glycemic and Weight Response to Tirzepatide: A Post Hoc Analysis of SURPASS-4

Article

Author: Pavo, Imre ; Nicolay, Claudia ; Hemmingway, Andrea ; Del Prato, Stefano ; Zheng, Junyuan ; Kahn, Steven E. ; Franco, Denise R. ; Pearson, Ewan R. ; Wiese, Russell J.

Article Highlights:

We aimed to explore sustainability of lowered glycated hemoglobin (HbA1c) and weight with tirzepatide in a post hoc analysis. The question we wanted to answer was what predicted achieving and sustaining HbA1c and weight reduction in A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4). We found greater weight loss and improved β-cell function were the main predictors for sustained glycemic control with tirzepatide therapy. No clinically relevant predictor was identified for sustained weight loss. Simple clinical measures may predict initial and sustained glycemic control and initial weight loss with tirzepatide.

01 Aug 2025·DIABETES OBESITY & METABOLISM

Post‐marketing safety of Lantus and its interchangeable biosimilar Semglee in the United States: A disproportionality analysis using the FDA Adverse Event Reporting System ( FAERS ) database

Article

Author: Ezeja, Lotanna ; Qian, Jingjing

Abstract:

Aims:

On 28 July 2021, Semglee (insulin glargine‐yfgn) was approved by the U.S. Food and Drug Administration as the first interchangeable biosimilar to the reference product Lantus (insulin glargine) for treating diabetes mellitus. This study used the FDA Adverse Event Reporting System to identify reporting safety signals of Lantus and Semglee.

Materials and Methods:

Adverse event (AE) reports were organized into high‐level group terms (HLGTs) using the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis, including reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM), was performed to detect safety signals for serious AE, death, hospitalization, top 6 HLGTs, and specific AEs on products' FDA prescription labels.

Results:

Both products showed no significant safety signal of serious AE, death, or hospitalization. Lantus exhibited significant safety signals for device issues (ROR = 1.3, 95% confidence interval [CI] = 1.2–1.4; EBGM = 1.3, 90% CI = 1.2–1.3), medication errors and other product use errors and issues (ROR = 2.8, 95% CI = 2.7–2.9; EBGM = 2.1, 90% CI = 2.0–2.1), metabolic, nutritional, and blood gas investigations (ROR = 11.7, 95% CI = 11.2–12.2; EBGM = 9.6, 90% CI = 9.3–9.9), hyperglycaemia (ROR = 2.7, 95% CI = 2.1–3.5; EBGM = 2.3, 90% CI = 1.9–2.8) and hypoglycaemia (ROR = 4.6, 95% CI = 3.6–5.8; EBGM = 3.7, 90% CI = 3.0–4.5). Semglee had significant safety signals for device issues (ROR = 118.7, 95% CI = 103.9–135.7; EBGM = 22.8, 90% CI = 21.7–23.9), medication errors and other product use errors and issues (ROR = 3.4, 95% CI = 3.0–3.8; EBGM = 2.3, 90% CI = 2.1–2.4), metabolic, nutritional, and blood gas investigations (ROR = 3.0, 95% CI = 2.3–3.9; EBGM = 2.5, 90% CI = 2.0–3.1), product quality, supply, distribution, manufacturing, and quality system issues (ROR = 5.4, 95% CI = 4.6–6.3; EBGM = 4.4, 90% CI = 3.9–5.0), physical examination and organ system status topics (ROR = 2.6, 95% CI = 2.0–3.2; EBGM = 2.2, 90% CI = 1.9–2.7), weight gain (ROR = 3.6, 95% CI = 2.6–4.8; EBGM = 2.7, 90% CI = 2.1–3.5), weight loss (ROR = 2.0, 95% CI = 1.4–2.9; EBGM = 1.7, 90% CI = 1.2–2.2), and lipodystrophy (ROR = 146.0, 95% CI = 96.1–221.8; EBGM = 116.0, 90% CI = 81.7–160.8).

Conclusions:

Findings identified significant post‐marketing safety signals of Lantus and Semglee. Longitudinal studies are warranted to verify these signals.

01 Jul 2025·DIABETES OBESITY & METABOLISM

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups—Sharing Canadian perspectives

Review

Author: Chu, L. ; Abitbol, A.

Abstract:

Background:

The rising cost of insulins are significantly impacting health care expenditure, thereby limiting access to treatment for more people affected by diabetes. Fear and misunderstanding of insulin therapy have worsened with the emergence of biosimilar insulins. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference.

Results:

There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty ™. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins.

Conclusion:

Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. Tailoring effective conversations to patient needs ensures the best possible therapeutic outcomes.

Plain Language Summary:

This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost‐effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials, comparative studies evaluating efficacy and safety and manufacturing quality control. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Health care providers are encouraged to stay up to date on the latest guidelines and recommendations regarding biosimilar insulin interchangeability to ensure safe and cost‐effective use of these products. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins. A summary of adults with diabetes from this registry showed 3.8% of individuals with T1D were prescribed Basaglar® before April 2023 compared to 12.0% after January 2024. For the T2D cohort, the use of basal biosimilar insulins, Basaglar® and Semglee®, similarly increased by approximately 10% and 2% after January 2024, respectively. The use of bolus biosimilar insulins also increased after January 2024 by approximately 28% in the T1D cohort and 60% in the T2D cohort using insulin therapy. Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. People living with diabetes must have access to safe and effective treatment options, and they should be able to obtain appropriate medications at an affordable price and in a fair and timely manner.

News (Medical) associated with Insulin Glargine(Mylan Nv)

21 Nov 2025

·pharma.economictimes.indiatimes.com

Biocon in very unique position globally as a biosimilars leader: Kiran Mazumdar-Shaw

Mumbai: Biocon is entering a transformative phase in its journey as a global biosimilars leader driven by regulatory shifts in the US, strategic partnerships and a robust insulin and GLP-1 portfolio, executive chairperson Kiran Mazumdar-Shaw said. The company is uniquely positioned to accelerate growth, reduce financial burden and expand its footprint in the high-value biologics space, Shaw told ET in an exclusive interview. "We are in a sweet spot and a very unique position," Shaw said. "Nobody else has interchangeable insulins and insulin now is becoming a very big opportunity for Biocon Biologics because of the fact that the actual insulin companies are planning to focus on GLP-1s. We are taking that advantage globally." Biocon is the only company with interchangeable biosimilar insulin analogues like insulin glargine (Semglee) and insulin aspart (Kirsty) in the US market. According to Shaw, the company's acquisition of Viatris' global portfolio of biosimilars, often scrutinised for its debt impact, has strengthened Biocon 's position as one of the top five biosimilars companies globally. Biocon Biologics acquired Viatris' global biosimilars business in 2022 for $3.3 billion and has been trying to cut acquisition-related debt of $1.2 billion. "People focus too much on the acquisition debt and not enough on the fact that we have become a leading global biosimilars company," said Mazumdar-Shaw. Referring to the company's R&D priorities in new therapeutic areas such as GLP-1 analogues , Mazumdar-Shaw said: "We have done this successfully for insulins and for liraglutide and are confident that semaglutide will be quite straightforward for us." According to Shaw, the recent draft guidelines by the USFDA, which propose to waive off the requirement for phase-III clinical trials for certain biosimilars that demonstrate robust chemistry, manufacturing and controls (CMC) package, presents a significant opportunity for Biocon . The USFDA's new draft guidance eliminates the need for most comparative efficacy trials-the costliest and slowest step in biosimilar development. Instead, it will allow developers to rely on advanced analytical and functional testing to demonstrate similarity with reference biologics. The agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily. "Once we get the first approval without phase-III trials, it will set the stage for more launches and significantly reduce our R&D costs." It will allow the company to do more for the same amount of R&D spend, creating a compelling advantage over competitors, according to Mazumdar-Shaw. Biocon has already delivered an array of biosimilars over the past 12-18 months, including ustekinumab (Yesintek, used to treat chronic autoimmune condition), aflibercept (Yesafili, used for treatment of certain eye conditions), insulin aspart (Kirsty), bevacizumab (Jobevne, a cancer drug), and recently denosumab (Bosaya and Aukelso indicated for osteoporosis and cancer-related bone). The company has also reached a settlement with Amgen for denosumab, enabling its upcoming US launch. With these approvals, Biocon is in the "acceleration" phase, having built a diversified portfolio that few competitors, including Sandoz, Amgen, Pfizer , Celltrion, or Samsung, can match in scale and vertical integration, said Mazumdar-Shaw. "We have a large basket of biosimilars now in the market and nobody else has this scale of products," she said. Biocon's cancer drugs Fulphila (pegfilgrastim) and Ogivri (trastuzumab) have over 25% US market share. "The kind of growth story we are creating is going to be exciting in the immediate five-year window and beyond," said Mazumdar-Shaw. "After 2030, there will be some very exciting products becoming big-ticket opportunities for companies like us, more cancer drugs PD-1s and many other products." The insulin and GLP-1 segments are emerging as high-growth adjacencies for Biocon. Shaw emphasised that the company's deep experience in insulin manufacturing and patient familiarity with Biocon devices provide a natural advantage in GLP-1 analogues , so introducing GLP-1 is seamless. By Rica Bhattacharyya ,

AcquisitionLicense out/inDrug Approval

21 Oct 2025

·pharma.economictimes.indiatimes.com

Civica to market Biocon Biologics Insulin Glargine in US

New Delhi: US-based non-profit pharmaceutical company Civica has bagged Biocon Biologics Insulin Glargine US commercial rights under a separate brand name. Bengaluru-based Biocon biosimilars arm has inked a multi-year transformational agreement with Civica, allowing the latter to distribute, promote, and sell the medicine in the US under a separate Civica label and trade dress. Under the agreement, no technology transfer is involved, and Biocon will continue to own the intellectual property (IP) and marketing authorization associated with the therapy. The Indian drugmaker will supply the drug to Civica and will continue to directly commercialize the therapy in the country. Biocon’s Insulin Glargine was approved by the US FDA in July 2021 as the first interchangeable biosimilar. Notably, the new agreement completes the insulin therapy regimen, as the two partners have already announced an agreement for Insulin as part ensuring access to both rapid-acting and long-acting insulin indicated for the management of diabetes. Commenting on the announcement, Shreehas Tambe, CEO and MD, Biocon Biologics Ltd , said,”...we are building on our differentiated approach to serving and enhancing patient access—by retaining our direct commercialization and through this strategic partnership.” “This collaboration enables us to reach underserved populations through new channels in direct alignment with our mission,” Tambe added. By Online Bureau ,

Drug ApprovalLicense out/in

16 Oct 2025

·endpoints.news

California to offer its own, cheaper version of insulin pens

California Gov. Gavin Newsom on Thursday unveiled a deal to keep insulin glargine pen prices down for diabetics in the state, offering Biocon’s interchangeable biosimilar for a suggested retail price of about half of what pharmacies currently pay for competitors offered by Eli Lilly and Sanofi. Beginning Jan. 1, 2026, the cheaper insulin for Californians, offered under the CalRx brand, will cost no more than $55 per five-pack of pens, Newsom said. The price was forged via a deal between Virginia-based nonprofit generic drugmaker Civica Rx and India-based Biocon Biologics. Biocon and Civica on Thursday announced a “multiyear” private label agreement where Biocon will manufacture and supply insulin glargine to Civica, and Civica will commercialize it under Biocon Biologics’ existing marketing approval. The push from California shows how states may look to take unique approaches to bring down drug prices, particularly for biologics like insulin, where prices remain persistently high despite ongoing competition. Civica expects to launch the same price for its insulin glargine pens in all 50 states on Jan. 1, the company’s chief government affairs officer Allan Coukell told Endpoints News . Biocon said it will continue to directly commercialize its own interchangeable biosimilar insulin glargine, known as Semglee, which launched in the US in November 2021. The current list price of Semglee is almost 10 times higher than what the CalRx biosimilar will retail at for a pack of five pens. In March 2022, Civica laid out plans for its suggested retail price of no more than $55 per pack of five pens, which compared at the time with a list price of $425 for Sanofi’s Lantus, $404 for Semglee, and $148 for unbranded Semglee. Now, Lilly’s insulin glargine, known as Rezvoglar, retails at about $89 per pack, according to the governor’s office, while its Basaglar pens cost more than $310. Lantus retails at $92, while Sanofi’s Toujeo version sells for $411 for a pack of five. “California didn’t wait for the pharmaceutical industry to do the right thing — we took matters into our own hands. By beginning the process to manufacture our own insulin and pricing it at a maximum cost of $11 a pen in a five-pack, California and Civica are showing the nation what it looks like to put people over profits,” Newsom said in a statement . Newsom also signed a bill on Monday that would ensure consumer cost-sharing for insulin at $35 for a month-long supply.

License out/inDrug Approval

100 Deals associated with Insulin Glargine(Mylan Nv)

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KEGG	Wiki	ATC	Drug Bank
D03250	-	A10AE04	DB00047

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Australia	Alphapharm Pty Ltd.	28 Mar 2018
Diabetes Mellitus, Type 1	Japan	FUJIFILM Toyama Chemical Co., Ltd.	28 Mar 2016
Diabetes Mellitus	India	-	21 Jan 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


818-P (ADA2024)	Phase 1	Diabetes Mellitus, Type 2	54	Efsitora	kgvlewaqyy(vvytscpkmz) = jtwmyzbbhx atvwflbiwy (omguqfzmxx ) View more	Positive	14 Jun 2024
				Glargine	kgvlewaqyy(vvytscpkmz) = mjnfsimgdq atvwflbiwy (omguqfzmxx ) View more
NCT03376789 (CTgov)	Phase 3	Diabetes Mellitus, Type 1	219	MYL-1501D product using manufacture process V (MYL-1501D (Process V Product))	aqflptamlz(uhovobxjbo) = ypzlhpmxpc rfmbxbwwlb (aobvgswdmh, 0.055) View more	-	03 Mar 2022
				MYL-1501D product using manufacture process VI (MYL-1501D (Process VI Product))	aqflptamlz(uhovobxjbo) = ncaksdnuhm rfmbxbwwlb (aobvgswdmh, 0.053) View more
NCT03819790 (VARIATION 2 SA, Pubmed \| Can J Diabetes)	Phase 4	Diabetes Mellitus, Type 2	104	iGlarLixi	kchqulhdph(qmyezoiveb) = npqpladipf zfgifryqau (gntqrnebpm, 16.8) View more	Positive	11 Feb 2022
				iGlar + gliclazide	kchqulhdph(qmyezoiveb) = fguuoycjxb zfgifryqau (gntqrnebpm, 21.6) View more
ADA2021	Not Applicable	Diabetes Mellitus, Type 1	185	Glargine at 6-7pm	xspvuinzfo(jvedfsmvzy) = ouwwyzhacm ddjmudxfvp (yebhrnufik ) View more	-	01 Jun 2021
				Glargine at 10-12 night	xspvuinzfo(jvedfsmvzy) = ouupnnofba ddjmudxfvp (yebhrnufik ) View more
NCT02443402 (SITACABG NonDM, CTgov)	Phase 4	Coronary Artery Disease \| Diabetes Mellitus \| Hyperglycemia	68	Sitagliptin+insulin+Regular Human Insulin+Insulin lispro+Insulin aspart+Insulin glargine (Sitagliptin)	aytmstyjgg = qesiiztjom ypfpombkcw (tcdhbvxbke, ofmuluybhw - vtokykpbvr) View more	-	06 Feb 2018
				Placebo+insulin+Regular Human Insulin+Insulin lispro+Insulin aspart+Insulin glargine (Placebo)	aytmstyjgg = iptcoxnxjv ypfpombkcw (tcdhbvxbke, qljqyvujic - kyiwddsogp) View more
Pubmed \| Endocr Pract	Phase 3	-	-	Insulin degludec	vsriafejpu(nribljceya): ERR = 0.86 (95% CI, 0.76 - 0.98)	Positive	01 Aug 2015
				Insulin glargine
NCT00391027 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	261	Exuber+Human Insulin (Inhaled Human Insulin (Exubera®))	jqeyvbgiqn(ogbeyllhol) = dbhfgfuoni wolhjhojdj (tmvtkkwgpk, 1.19) View more	-	21 Oct 2009
				Lantus+Insulin Glargine (Insulin Glargine (Lantus®))	jqeyvbgiqn(ogbeyllhol) = mzyrxubdae wolhjhojdj (tmvtkkwgpk, 1.14) View more

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