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.)

473

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

01 Jan 2025·Diabetes Therapy

Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study

Article

Author: Kenzler, Julia ; Bilz, Stefan ; Gölz, Stefan ; Danne, Thomas ; Mader, Julia K

INTRODUCTION:

Appropriate glycemic control is paramount for people with type 1 diabetes (PwT1D) by the effective delivery of exogenous insulin. However, glycemic variability and the risk of severe hypoglycemia must be reliably controlled.

METHODS:

COMET-T is a prospective, multicenter, observational study conducted in Germany, Austria, and Switzerland during 2021-2022 to assess the effectiveness and safety of insulin glargine 300 U/ml (Gla-300) after switching from other basal insulins. Out of 135 PwT1D, data of 94 patients were analyzed. The primary endpoint was the change in time in range (TIR) approximately 12 and 24 weeks after switching to Gla-300. Secondary endpoints were: change in HbA_1c, fasting plasma glucose (FPG), coefficient of variation (CV%) of plasma glucose, body weight (BW) and insulin dose.

RESULTS:

Patients had mean age of 48.6 ± 16.5 years, included 39.4% males and had 18.2 ± 15.5 years T1D duration. From baseline (54.3%), TIR changed at week 12 (mean change 0.3% [± 14.3]; p = 0.8383) and at week 24 (+ 4.5% [± 14.9], p = 0.078). At week 24, TIR significantly increased in patients with body mass index > 30 kg/m² (8.4% [± 12.8] p = 0.0057) and patients who previously received insulin detemir (10.5%; [± 12.93]; p = 0.0005). At week 24, there was a significant reduction in the HbA_1c value (8.1 ± 0.6% vs. 7.7 ± 0.9%; p < 0.001), a reduction in the CV% of plasma glucose (36.1 ± 12.4% vs. 32.8 ± 9.6%, p = 0.056), and increase in bolus insulin dose (26.5 ± 16.3 vs. 27.9 ± 16.6 U/day; p = 0.042). FPG, BW, and basal insulin doses were not significantly changed.

CONCLUSIONS:

Although switching to Gla-300 in poorly controlled PwT1D did not significantly reduce TIR, it significantly decreased HbA_1c values and glycemic variability without changes in BW and basal insulin dose.

01 Nov 2024·Diabetes Therapy

Real-Life Effectiveness of iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) in People with Type 2 Diabetes (T2D) According to Baseline HbA1c and BMI

Article

Author: Seufert, Jochen ; Haluzík, Martin ; Bonnemaire, Mireille ; Guja, Cristian ; Vera, Carine ; Kis, Janos T ; Freemantle, Nick ; Kis, Janos T. ; Tournay, Mathilde

INTRODUCTION:

This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice.

METHODS:

We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m² and 510 (36%) a BMI < 30 kg/m²; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%.

RESULTS:

After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups.

CONCLUSIONS:

Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.

01 Nov 2024·Diabetes Therapy

Quality of Life in Japanese People with Type 2 Diabetes Switching from Multiple Daily Insulin Injections to Once-Daily iGlarLixi: SIMPLIFY Japan

Article

Author: Morimoto, Yukiko ; Yabe, Daisuke ; Takahashi, Yoko ; Ishii, Hitoshi ; Kamiya, Hideki

INTRODUCTION:

Previous studies have shown that iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, provides effective glycemic control in people with type 2 diabetes (T2D). The SIMPLIFY Japan study assessed the impact of switching from multiple daily insulin injections (MDI) to once-daily iGlarLixi on health-related quality of life (HRQOL) and glycemic parameters in Japanese people with moderately controlled T2D.

METHODS:

This 24-week, prospective, observational cohort study enrolled Japanese adults with T2D who switched from MDI therapy to iGlarLixi. Data were collected at baseline, 12, and 24 weeks; changes in Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire score, glycated hemoglobin (HbA1c), body weight and self-reported treatment adherence were evaluated; the primary endpoint was change in DTR-QOL at 24 weeks.

RESULTS:

Sixty-six participants were enrolled and 61 were included in the full analysis set. Significant improvements were observed in total DTR-QOL score from baseline to week 24 (mean change + 10.8 points; P < 0.001), with higher scores observed in individual domains related to social/daily activities, treatment satisfaction, and reductions in treatment-related anxiety (P < 0.05). A small HbA1c increase was noted at week 24 (P < 0.001), while this did not appear to adversely affect HRQOL or treatment satisfaction. A significant reduction in body weight was observed at week 12 (mean change - 0.7 kg; P = 0.046). Self-reported treatment adherence increased from baseline to week 24, with the proportion of participants who never missed an insulin injection increasing from 55.7 to 77.6%. At week 24, the incidence of hypoglycemia and gastrointestinal adverse events was 18.2 and 27.3%, respectively.

CONCLUSIONS:

Switching from MDI to iGlarLixi therapy in Japanese people with T2D was associated with enhanced HRQOL (despite slight elevation in HbA1c) and improved treatment adherence, with a favorable safety profile. These findings support the beneficial role of iGlarLixi in the management of T2D in real-world Japanese clinical practice.

STUDY REGISTRATION:

Japan Registry of Clinical Trials (jRCT1041210151).

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

10 top approved records.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02059161 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 1	508	MK-1293 insulin glargine	xcufgritjp(hjsydrqgzk) = anzpgrieem mhrgjxhjuz (ytuvknujrm, -0.79 to -0.45)	Similar	01 Sep 2018
				insulin glargine+Lantus	xcufgritjp(hjsydrqgzk) = crsslkfumu mhrgjxhjuz (ytuvknujrm, -0.82 to -0.50)
NCT02059187 (1293-006, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	526	MK-1293 insulin glargine	lltpttzvqo(irdxwokfbq) = efbwadulvk dfmkymcxml (eidegjnodl, -1.41 to -1.15)	Similar	01 Sep 2018
				insulin glargine	lltpttzvqo(irdxwokfbq) = jxaorsthnz dfmkymcxml (eidegjnodl, -1.43 to -1.18)
NCT02059187 (1293-006, CTgov)	Phase 3	Diabetes Mellitus, Type 2	531	Prandial insulin+MK-1293 (MK-1293)	cimnpdvamx(klievnabwn) = yrqerikdey htyydlzobt (vamjukteax, gdeahgmskw - ndfwaqwqej) View more	-	08 Mar 2017
				Prandial insulin+Lantus™ (Lantus™)	cimnpdvamx(klievnabwn) = valhbbvhfe htyydlzobt (vamjukteax, zqqhprplof - xfbwfxgdce) View more
NCT02059161 (1293-003, CTgov)	Phase 3	Diabetes Mellitus, Type 1	508	Prandial Insulin+MK-1293 (MK-1293)	fckbrmodab(uoabvejmhk) = zzfaqqzamx tueqwibzea (xhhsvahsrs, jqjjmmmoni - ydsoilnkus) View more	-	08 Mar 2017
				Prandial Insulin+Lantus™ (Lantus)	fckbrmodab(uoabvejmhk) = sklylikolt tueqwibzea (xhhsvahsrs, xgepatypdv - fjxzwdertx) View more
EASD2015	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin Glargine	svqljlrnsx(tjnmledgqc) = huiwsanegl mfsericwnl (pzwrbzozkr ) View more	Positive	16 Sep 2015
				Non-Glargine Basal Insulin	svqljlrnsx(tjnmledgqc) = izcqpomtrl mfsericwnl (pzwrbzozkr ) View more
INITIATOR (EASD2014)	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine pen (GLA)	limncvppma(gqogijedbn) = LIRA (OP and HC) and GLA patients (OP only) incurred higher diabetes drug costs afntdczvxn (imuhlhlygc ) View more	Positive	17 Sep 2014
				GLP-1 analogue liraglutide (LIRA)
EASD2013	Not Applicable	Diabetes Mellitus, Type 2	9	Insulin glargine 10 AM	idkbuwdemu(dvmptwqwzr) = clxzkiqppm lylidbpssl (vafwtcjtsx ) View more	Positive	26 Sep 2013
				Insulin glargine 10 PM	idkbuwdemu(dvmptwqwzr) = qmccjndjwp lylidbpssl (vafwtcjtsx ) View more
EASD2012	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine	guqqgkxbfg(bkaordpaxm) = dfdpwnkrye rawtatrzln (sdbnjlwzkx, 50eventsper1 - 000person-yearsatrisk)	Positive	04 Oct 2012
				Intermediate/long-acting HI	guqqgkxbfg(bkaordpaxm) = pmdhqbugva rawtatrzln (sdbnjlwzkx, 123eventsper1 - 000person-yearsatrisk)

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