Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patients with renal impairment - Renal-TIR

Start Date09 May 2022

Sponsor / Collaborator-

ChiCTR2000040250

/ SuspendedEarly Phase 1IIT

Observation on the efficacy of application in the treatment of type 2 diabetes with insulin glargine

Start Date01 Mar 2021

Sponsor / Collaborator-

ChiCTR-IIR-17011018

/ SuspendedPhase 4IIT

Study of efficacy and safety of higher starting dose of insulin glargine in overweight and obese newly-diagnosed hospitalized patients with type 2 diabetes

Start Date30 May 2017

Sponsor / Collaborator

Shenzhen Second People's Hospital

100 Clinical Results associated with Insulin Glargine(Samsung Bioepis Co., Ltd.)

100 Translational Medicine associated with Insulin Glargine(Samsung Bioepis Co., Ltd.)

100 Patents (Medical) associated with Insulin Glargine(Samsung Bioepis Co., Ltd.)

2,250

Literatures (Medical) associated with Insulin Glargine(Samsung Bioepis Co., Ltd.)

01 Feb 2025·DIABETES OBESITY & METABOLISM

Treatment persistence, adherence and healthcare resource utilisation for iGlarLixi versus basal–bolus insulin or premixed insulin in older adult ethnic minorities with type 2 diabetes: SoliEthnicity study

Article

Author: Li, Xuan ; Gill, Jasvinder ; Núñez, Ana ; Umpierrez, Guillermo ; Hood, David

Abstract:

Aims:

Most type 2 diabetes (T2D) studies have predominantly enrolled White people aged <65 years. This retrospective study evaluated outcomes for iGlarLixi (fixed‐ratio combination [FRC] of insulin glargine 100 U/mL and lixisenatide) versus basal–bolus or premixed insulin in African American, Asian and Hispanic adults with T2D aged ≥65 years.

Methods:

Medicare claims data were assessed from beneficiaries receiving basal insulin who newly initiated iGlarLixi, basal–bolus insulin, or premixed insulin between 7/1/2019 and 12/30/2021. Groups were propensity score matched at baseline and followed for up to 12 months. Endpoints (primary: treatment persistence; secondary: treatment adherence, hypoglycaemia event rates, healthcare resource utilisation) were assessed using multivariable regression.

Results:

Treatment persistence was higher for iGlarLixi versus basal–bolus or premixed insulin in the overall population (26.9%, 7.6%, 18.9%; adjusted p < 0.0001) and numerically higher in all ethnic subgroups. Treatment adherence was numerically higher for iGlarLixi versus basal–bolus or premixed insulin in the overall population (28.0%, 8.0%, 19.0%) and in all subgroups. Hypoglycaemia event rates were numerically lower for iGlarLixi versus basal–bolus insulin or premixed insulin in the overall population (2.5, 3.8, 7.5/100 person‐years' follow‐up) and in all subgroups except Asians receiving basal–bolus insulin. All‐cause and diabetes‐related hospitalisation and emergency department visit event rates were lower with iGlarLixi versus basal–bolus insulin or premixed insulin in the overall population, and in all subgroups except for hospitalisations in Hispanics.

Conclusion:

FRC therapies such as iGlarLixi represent an appropriate treatment option when intensifying basal insulin therapy in ethnic minority older adults with T2D.

01 Jan 2025·DIABETES OBESITY & METABOLISM

Cost‐utility analysis of once‐weekly insulin icodec and once‐daily insulin glargine in patients with type 2 diabetes receiving basal‐bolus insulin therapy in China

Article

Author: Wang, Yong ; Dai, Nan ; Su, Xiaorong

Abstract:

Objective:

The purpose of this study is to explore the rational pricing range for the once‐weekly administration of insulin icodec in the treatment of type 2 diabetes patients in China who have already received basal insulin therapy.

Methods:

The data foundation of this study originates from the ONWARDS 4 clinical trial and research materials on Chinese type 2 diabetes patients. By comprehensively applying cost‐utility analysis methods and binary search techniques, the appropriate price positioning of insulin icodec was determined from the perspective of China's healthcare system.

Results:

In the long‐term treatment simulation, we found that insulin icodec and insulin glargine performed similarly in terms of quality‐adjusted life years (QALYs), with 10.15 and 10.07 years, respectively. Although the annual cost of insulin icodec was initially assumed to be equivalent to that of insulin glargine, in‐depth analysis revealed that insulin icodec may have higher cost‐effectiveness potential. Further price sensitivity analysis indicated that the reasonable cost range of insulin icodec lies between $851.95 and $1358.25. After fine‐tuning through univariate sensitivity analysis, this cost range was revised to $784.90 to $1145.96, a conclusion that was robustly validated in subsequent probabilistic sensitivity analysis and scenario simulations.

Conclusion:

The conclusion drawn from this study is that, with insulin glargine as the cost reference, the economic cost of insulin icodec for Chinese type 2 diabetes patients is expected to range from $784.90 to $1145.96, providing a reference basis for clinical decision‐making and healthcare policy formulation.

01 Jan 2025·DIABETES OBESITY & METABOLISM

Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve individuals according to diabetes duration: Results from the REALI European pooled data analysis

Article

Author: Gourdy, Pierre ; Vera, Carine ; Bonnemaire, Mireille ; Mauquoi, Celine ; Müller‐Wieland, Dirk ; Mauricio, Didac ; Bonadonna, Riccardo C. ; Freemantle, Nick

Abstract:

Aim:

To evaluate the effectiveness and safety of insulin glargine 300 U/mL (Gla‐300) initiation according to diabetes duration (DD).

Materials and Methods:

We analysed patient‐level data from 2381 insulin‐naïve individuals with type 2 diabetes (T2D), of whom 2349 (98.7%) were treated with Gla‐300 for 24 weeks. Of the 2381 participants, 1048 (44.0%) had a DD of less than 8 years and 1333 (56.0%) had a DD of 8 years or longer. We further analysed the subgroups of participants having a DD of less than 4 years (N = 450), 4‐8 years (N = 598), 8‐12 years (N = 627) and 12 years or longer (N = 706).

Results:

Mean ± standard deviation age was 60.2 ± 9.0 years in participants with a DD less than 8 years and 64.2 ± 8.8 years in those with a DD of 8 years or longer. At 24 weeks of Gla‐300 therapy, HbA1c improved with a least‐squares (LS) mean change from baseline of −1.88% (95% confidence interval [CI], −1.95 to −1.80) and −1.71% (95% CI, −1.77 to −1.65), respectively, resulting in a LS mean difference between groups of 0.17% (95% CI, 0.07 to 0.26; P = .0005). In the subgroup analysis, LS mean HbA1c reduction from baseline to week 24 was highest in participants with a DD of less than 4 years and lowest in participants with a DD of 12 years or longer. Overall, incidences of symptomatic and severe hypoglycaemia were low, irrespective of DD, without body weight changes.

Conclusions:

Gla‐300 was effective and safe in insulin‐naïve individuals with T2D, regardless of DD. Improvement in HbA1c was greater when Gla‐300 was initiated in participants with a DD of less than 4 years, although the difference between the groups was modest.

News (Medical) associated with Insulin Glargine(Samsung Bioepis Co., Ltd.)

19 Dec 2024

·endpts.com

Lonza expands capsule footprint; BioCentriq's new HQ

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Lonza is expanding its manufacturing sites in Rewari, India, and Suzhou, China, for hard gelatin capsules, the CDMO said Thursday, despite the company flagging last week that it is looking to exit the capsule and health ingredients market. The new manufacturing lines will be online in the third quarter of 2025. BioCentriq is building a new 60,000-square-foot headquarters in Princeton, NJ, which will have cell therapy manufacturing, the CDMO said Tuesday. The factory also has potential for future clinical and commercial manufacturing expansions up to 30,000 square feet. The site will be fully operational in the second quarter of next year. Thermo Fisher Scientific is divesting its commercial samples business to Knipper Health for an undisclosed sum. Knipper will absorb Thermo Fisher’s Memphis, TN, facility as well as an undisclosed number of employees. The transaction will be completed by September 2025 and will expand Knipper’s cold chain footprint, according to a Wednesday press release. New York’s first cell and gene therapy manufacturing facility has opened at the Roswell Park Comprehensive Cancer Center in Buffalo, according to a Monday release. The factory cost $98 million to build, with $30 million from Empire State Development. Eli Lilly and EVA Pharma have won approval for their insulin glargine injection from the Egyptian Drug Authority, Lilly said Tuesday. The companies started their partnership in December 2022, with Lilly supplying APIs to EVA, who manufactures the insulin products locally. Bavarian Nordic is licensing its mpox vaccine to the Serum Institute of India under a new partnership, it announced Monday. Bavarian will allow SII to manufacture and distribute the MVA-BN vaccine in India. Valneva is also licensing its single-shot chikungunya vaccine to SII, who will manufacture and seek approval for the asset in India and other parts of Asia, according to a Thursday release. Samsung Biologics is investing , via its Life Science Fund, in the Flagship-founded company Generate:Biomedicines, according to a Wednesday release. Generate uses AI software to discover and design protein therapies. No financial details were disclosed. Celltrion has launched a new CDMO arm, dubbed Celltrion BioSolutions, the company said Tuesday. Theratechnologies has submitted a Prior Approval Supplement to the FDA outlining the changes it made to the manufacturing of its drug Egrifta, which is approved in the US to reduce belly fat in HIV and lipodystrophy patients. The FDA has four months to OK the manufacturing changes, the company said Wednesday. VaxSen has drawn support from the US International Development Finance Corporation, the African Development Bank, and the International Finance Corporation worth $45 million to improve local vaccine supply chains in Africa, according to a Tuesday release. Polyrizon has tapped the CDMO Eurofins, also called Amatsiaquitaine, to supply material for its PL-14 allergy blocker, which is entering a study next year, according to a Wednesday release. French pharma company Biocodex tapped the logistics firm Kinaxis to access its supply chain platform, according to a Monday release. BioVaxys has secured 48 kgs of lipids to start its antigen packaging platform, the company said Tuesday. The platform can package mRNA, proteins, peptides and small molecules. Moberg Pharma has secured a new manufacturer and supplier of an ingredient (terbinafine) for its nail fungus drug named MOB-015, according to a Wednesday release.

VaccineDrug ApprovalAcquisitionClinical StudymRNA

10 Sep 2024

·www.pharmaceutical-technology.com

EASD 2024: Eli Lilly releases Phase III data for once-weekly insulin in diabetes

Eli Lilly is conducting five registrational QWINT studies to establish that once-weekly insulin efsitora is not inferior to daily insulin injection in managing type 1 and 2 diabetes. Image Credit: Tada Images / Shutterstock. Eli Lilly has released detailed results from the Phase III QWINT-2 and QWINT-5 trial showing that its once weekly insulin efsitora (efsitora alfa) demonstrated a similar reduction in HbA1C levels compared to daily insulin injections in adults with type 2 and type 1 diabetes, respectively. The company is conducting five registrational QWINT studies to establish that once-weekly efsitora is not inferior to daily insulin injection in managing type 1 and 2 diabetes. The results from the two QWINT studies were presented at the European Association for the Study of Diabetes (EASD) 2024 meeting taking place from 9-13 September in Spain. The QWINT-2 and QWINT-5 data were also concurrently published in the New England Journal of Medicine and the Lancet . The data presentation comes on the heels of the positive topline data from the QWINT-1 and QWINT-3 trials . Both studies met their primary endpoint by demonstrating that efsitora’s HbA1C reduction was non-inferior to that of insulin glargine and insulin degludec, respectively. Diabetes is a high-grossing indication for Lilly. Apart from the GLP-1 receptor agonists, which have generated billions for Lilly in both diabetes and obesity indications, the company’s insulin products have been extremely successful too. Humalog (insulin lispro), a fast-acting insulin, raked in $1.67bn in sales last year, as per the company’s financials. The randomised open label QWINT-2 trial (NCT05362058) enrolled 928 participants with type 2 diabetes. The study compared insulin efsitora to insulin degludec. At 52 weeks, participants on efsitora reduced their mean HbA1C levels by −1.26 percentage points comparable to the −1.17 percentage point reduction seen in the insulin degludec group. The non-inferiority in Hb1C reduction was maintained whether the participants used GLP-1 receptor agonists or not. See Also: FDA grants breakthrough therapy designation to Neuraptive’s NTX-001 FDA grants breakthrough therapy status to Arrowhead’s plozasiran No episodes of severe hypoglycaemia were observed in the efsitora group, whilst six participants in the degludec group suffered from severe hypoglycaemic episodes. The number of nocturnal hypoglycaemic episodes was similar for both groups, 32 in the efsitora group and 35 in degludec group. The randomised open-label QWINT-5 trial (NCT05463744) enrolled 893 participants with type 1 diabetes. The participants received either insulin efsitora to insulin degludec in combination with insulin lispro. At 26 weeks, participants on efsitora reduced their mean HbA1C levels by -0.51%, comparable to the -0.56% reduction seen in the insulin degludec group. Rates of hypoglycaemia were higher with efsitora compared with degludec, with 10% of patients in efsitora group observing severe hypoglycaemia compared to 3% in the degludec group.

Phase 3Clinical ResultBreakthrough TherapyPhase 2

09 Sep 2024

·pmlive.com

Eli Lilly’s once-weekly insulin candidate shows promise in late-stage diabetes trials

Eli Lilly’s once-weekly insulin candidate efsitora alfa has shown promise as a treatment for type 2 diabetes (T2D), according to new late-stage results announced by the company. It is hoped that the introduction of an insulin option specifically designed for once-weekly subcutaneous administration could improve adherence rates and quality of life for patients with the chronic condition. The phase 3 QWINT-1 trial randomised adults with T2D who were using basal insulin for the first time to receive either efsitora or once-daily insulin glargine. Efsitora was titrated across four fixed doses at four-week intervals, as needed for blood glucose control, Lilly said, noting that fixed dose regimens could make it easier for patients to start and manage insulin therapy. The primary endpoint of non-inferior A1C reduction at 52 weeks was met, with efsitora reducing A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively. Non-inferior A1C reductions were also seen in the phase 3 QWINT-3, which compared efsitora to once-daily insulin degludec in adults switching from daily basal injections. Efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26, resulting in an A1C of 6.93% and 7.03%, respectively. The overall safety and tolerability profile of efsitora was similar to that of daily T2D basal insulin therapies in both QWINT-1 and QWINT-3, Lilly said, adding that detailed results from the studies will be shared at an upcoming congress and published in a peer-reviewed journal. More than 4.3 million people in the UK have diabetes and T2D accounts for approximately 90% of all cases. There is currently no cure for T2D, with current treatment options focused on disease management, including diet and exercise, diabetes medications and insulin therapy. Jeff Emmick, senior vice president, product development at Lilly, said: “Many patients are reluctant to start insulin because of the burden it places on them. “With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives.”

Phase 3Clinical Result

100 Deals associated with Insulin Glargine(Samsung Bioepis Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
D03250	-	A10AE04	DB00047

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Merck Sharp & Dohme BV	03 Jan 2017
Diabetes Mellitus	IS	Merck Sharp & Dohme BV	03 Jan 2017
Diabetes Mellitus	LI	Merck Sharp & Dohme BV	03 Jan 2017
Diabetes Mellitus	NO	Merck Sharp & Dohme BV	03 Jan 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	-	Merck Sharp & Dohme Corp.	11 Feb 2014
Diabetes Mellitus, Type 1	Phase 3	-	Merck Sharp & Dohme Corp.	17 Oct 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02059187 (1293-006, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	526	MK-1293 insulin glargine	zuvaehribi(gyotvrdckk) = dyoderwqqp qmgassmasv (oiiwpxhjgt, -1.41 to -1.15)	Similar	01 Sep 2018
				insulin glargine	zuvaehribi(gyotvrdckk) = qwuetmbada qmgassmasv (oiiwpxhjgt, -1.43 to -1.18)
NCT02059161 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 1	508	MK-1293 insulin glargine	wgbdetimcn(kuccfugjga) = fqdinlcjop yjoegsiatl (ofzfzafipo, -0.79 to -0.45)	Similar	01 Sep 2018
				insulin glargine+Lantus	wgbdetimcn(kuccfugjga) = zrpsjfjlio yjoegsiatl (ofzfzafipo, -0.82 to -0.50)
NCT02059161 (1293-003, CTgov)	Phase 3	Diabetes Mellitus, Type 1	508	Prandial Insulin+MK-1293 (MK-1293)	webchwbvjm(zpcouicbun) = ipwobimhpf npjzdxpiqx (ieqhogtmpw, kfpxotdoho - zkdibsznxq) View more	-	08 Mar 2017
				Prandial Insulin+Lantus™ (Lantus)	webchwbvjm(zpcouicbun) = bkbdheotsa npjzdxpiqx (ieqhogtmpw, lhfbaupxej - bsssqoxhou) View more
NCT02059187 (1293-006, CTgov)	Phase 3	Diabetes Mellitus, Type 2	531	Prandial insulin+MK-1293 (MK-1293)	hatnnqcurd(chzobmhzqq) = hphpuxpfgi nahmnbzlry (vtoacjmjck, txskmprqfr - kgdtdtxrnk) View more	-	08 Mar 2017
				Prandial insulin+Lantus™ (Lantus™)	hatnnqcurd(chzobmhzqq) = bnhbhkhbnz nahmnbzlry (vtoacjmjck, cvruudyprw - hkmispjyyf) View more
EASD2015	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin Glargine	hnxnrupqfw(pbjxngrsof) = pphkjvkplr qypzuoxmqy (acanbwjivt ) View more	Positive	16 Sep 2015
				Non-Glargine Basal Insulin	hnxnrupqfw(pbjxngrsof) = pshqbtkwrg qypzuoxmqy (acanbwjivt ) View more
INITIATOR (EASD2014)	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine pen (GLA)	angxqogkes(jypxguewcs) = LIRA (OP and HC) and GLA patients (OP only) incurred higher diabetes drug costs grgpoqpcin (ydqelarzky ) View more	Positive	17 Sep 2014
				GLP-1 analogue liraglutide (LIRA)
EASD2013	Not Applicable	Diabetes Mellitus, Type 2	9	Insulin glargine 10 AM	khiqrunnfx(rwofambjse) = alhsmtpmdj sizmrghmhj (tvjsokgktu ) View more	Positive	26 Sep 2013
				Insulin glargine 10 PM	khiqrunnfx(rwofambjse) = aohkshlnhu sizmrghmhj (tvjsokgktu ) View more
EASD2012	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine	rqlyqeqqfc(zwpsodxski) = diagxgsqfi jnsslddpxd (dugjfzpapt, 50eventsper1 - 000person-yearsatrisk)	Positive	04 Oct 2012
				Intermediate/long-acting HI	rqlyqeqqfc(zwpsodxski) = fzvvrvqwms jnsslddpxd (dugjfzpapt, 123eventsper1 - 000person-yearsatrisk)

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