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https://www.readbyqxmd.com/read/29453671/comparative-evaluation-of-pharmacokinetics-and-pharmacodynamics-of-insulin-glargine-glaritus-%C3%A2-and-lantus-%C3%A2-in-healthy-subjects-a-double-blind-randomized-clamp-study
#1
Ashima Bhatia, Shraddha Tawade, Mushtaque Mastim, Eliford Ngaimisi Kitabi, Mathangi Gopalakrishnan, Manish Shah, Sridhar Yeshamaina, Joga Gobburu, Maharaj Sahib, Dipak Thakur, K M Prasanna Kumar
AIMS: The objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus ® (test) with the innovator's formulation Lantus ® (reference) using the euglycemic clamp technique in a single-dose, double-blind, randomized, two sequences, four-period replicate crossover study in healthy volunteers (n = 40). METHODS: Subjects received subcutaneous administration of the insulin glargine (0...
February 16, 2018: Acta Diabetologica
https://www.readbyqxmd.com/read/29368288/ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#2
Yvette N Lamb, Yahiya Y Syed
Subcutaneous once-daily LY2963016 insulin glargine (LY insulin glargine) [Abasaglar® (EU); Basaglar® (USA)] has been approved in the EU as a biosimilar to reference insulin glargine (Lantus®), and in the USA as a follow-on biologic to reference insulin glargine, for use in patients with type 1 or 2 diabetes. Structural and functional characterization of LY insulin glargine in preclinical studies showed that it is similar to reference insulin glargine. In phase I euglycaemic clamp studies, LY insulin glargine demonstrated similar pharmacodynamic (including duration of action) and pharmacokinetic parameters to reference insulin glargine...
January 24, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29355435/anti-insulin-antibodies-and-adverse-events-with-biosimilar-insulin-lispro-compared-with-humalog-insulin-lispro-in-people-with-diabetes
#3
Philip Home, Karl-Michael Derwahl, Monika Ziemen, Karin Wernicke-Panten, Suzanne Pierre, Yvonne Kirchhein, Satish K Garg
BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog®; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both in combination with insulin glargine (Lantus®). SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this study, the impact of anti-insulin antibodies (AIA) to SAR-Lis and Ly-Lis on safety and glycemic control is reported...
February 2018: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29232162/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-2-diabetes-also-using-insulin-glargine-sorella-2-study
#4
Karl-Michael Derwahl, Timothy S Bailey, Karin Wernicke-Panten, Lin Ping, Suzanne Pierre
BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult patients with type 2 diabetes mellitus (T2DM) treated with multiple daily injections, while using insulin glargine (GLA-100; Lantus®) as basal insulin. METHODS: SORELLA 2 was a 6-month, randomized, open-label, Phase 3 study (NCT02294474). Insulin doses were adjusted to achieve fasting and 2-h postprandial glucose targets according to American Diabetes Association guidelines...
December 12, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/29029025/insulin-deficient-mouse-%C3%AE-cells-do-not-fully-mature-but-can-be-remedied-through-insulin-replacement-by-islet-transplantation
#5
Adam Ramzy, Majid Mojibian, Timothy J Kieffer
Insulin receptor insufficiency in β-cells leads to impaired insulin secretion and reduced β-cell hyperplasia in response to hyperglycemia. Selective insulin receptor deficiency in β-cells in later embryological development may lead to compensatory β-cell hyperplasia. Though these findings suggest insulin signaling on the β-cell is important for β-cell function, they are confounded by loss of signaling by the IGFs through the insulin receptor. To determine if insulin itself is necessary for β-cell development and maturation, we performed a characterization of pancreatic islets in mice with deletions of both non-allelic insulin genes (Ins1-/-Ins2-/-)...
September 27, 2017: Endocrinology
https://www.readbyqxmd.com/read/28940840/ly2963016-insulin-glargine-and-insulin-glargine-lantus-produce-comparable-pharmacokinetics-and-pharmacodynamics-at-two-dose-levels
#6
Xin Zhang, Eric Chen Quin Lam, Mary E Seger, David Coutant, Laiyi Chua, Lai Hock Tan, Danny Soon, Helle Linnebjerg
LY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products with identical amino acid sequences. This was a phase 1 single-site, randomized, subject- and investigator-blinded, 4-treatment, 4-period crossover study to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of LY IGlar and IGlar at 2 different doses. Fasted healthy subjects were randomly assigned to receive 2 single doses of LY IGlar and IGlar (0.3 and 0.6 U/kg for each product). Blood samples were collected up to 24 hours postdose to assess PK, and a euglycemic clamp lasting up to 24 hours postdose was conducted to assess PD...
September 21, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28817223/single-dose-euglycemic-clamp-studies-demonstrating-pharmacokinetic-and-pharmacodynamic-similarity-between-mk-1293-insulin-glargine-and-originator-insulin-glargine-lantus-in-type-1-diabetes-and-healthy-subjects
#7
Michael Crutchlow, John S Palcza, Kate M Mostoller, Chantal D Mahon, April M Barbour, Michael C Marcos, Yang Xu, Elaine Watkins, Linda Morrow, Marcus Hompesch
AIMS: MK-1293 is an insulin glargine that has an identical amino acid sequence to that of Lantus, the originator insulin glargine. Two euglycemic clamp studies, one in subjects with Type 1 diabetes (T1D) and one in healthy subjects, were conducted to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293 and Lantus commercially procured in both the European Union (EU-Lantus) and United States (US-Lantus). MATERIALS AND METHODS: Both studies were single-dose, randomized, double-blind, single-center, crossover studies with ≥7 days between dosing periods...
August 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28722480/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-1-diabetes-also-using-insulin-glargine-sorella-1-study
#8
Satish K Garg, Karin Wernicke-Panten, Maria Rojeski, Suzanne Pierre, Yvonne Kirchhein, Krystyna Jedynasty
BACKGROUND: SAR342434 is a biosimilar follow-on of insulin lispro-Humalog(®). This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus(®); GLA-100). MATERIALS AND METHODS: SORELLA-1 was a randomized, open-label phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension...
September 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28643298/a-comparison-of-clinical-efficacy-and-economic-value-in-basalin-and-lantus-treated-patients-with-type-2-diabetes-using-continuous-glucose-monitoring-system
#9
H Q Li, C F Lu, J Wang, G P Yin, R Sun, X H Xu, B L Liu, F F Li, T Jing, K O Lee, L Ye, J H Ma, X F Su
AIM: To determine the clinical non-inferiority of recombinant glargine-Basalin vs glargine-Lantus, in treatment of type 2 diabetes mellitus (T2DM) using continuous glucose monitoring system (CGMS). METHODS: One hundred patients with T2DM were recruited. They were either regularly taking Basalin (Basalin group) or Lantus (Lantus group) (n = 50 each). CGMS was employed to real-time monitor blood glucose profile for 4 days (from day 1 to day 5). To exclude the effect of patient background, the study design was to have a blinded crossover from glargine-Basalin to glargine-Lantus on day 3, and vice versa...
June 22, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28623551/which-patients-will-benefit-from-a-switch-in-therapy-from-premixed-insulin-to-insulin-glargine-plus-oral-antidiabetic-drugs-further-analysis-of-the-lantus-registry-study
#10
Shi Bu, Xuelian Zhang, Haiqing Zhu, Ying Shuai, Xiaoyan Xing, Wenying Yang
INTRODUCTION: This subgroup analysis of data from the 16-week Lantus Registry Study in China investigated the characteristics of patients with type 2 diabetes mellitus (T2DM) associated with clinical benefits of transitioning therapy from premixed insulin to insulin glargine (100 U/ml) plus oral antidiabetic drugs (OADs). METHODS: The modified intention-to-treat population of the Lantus Registry Study, comprising 1847 patients with T2DM, were included in the current subgroup analyses...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28526658/nonclinical-pharmacology-and-toxicology-of-the-first-biosimilar-insulin-glargine-drug-product-basaglar-%C3%A2-abasaglar-%C3%A2-approved-in-the-european-union
#11
Richard A Byrd, Rebecca A Owens, Jamie L Blackbourne, David E Coutant, Mark W Farmen, M Dodson Michael, Julie S Moyers, A Eric Schultze, Michael K Sievert, Niraj K Tripathi, John L Vahle
Basaglar(®)/Abasaglar(®) (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus(®) (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity...
May 17, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28511765/basaglar-an-insulin-follow-on-prepares-to-do-battle-with-lantus
#12
Thomas Reinke
Basaglar is coming on the scene during tumultuous times for insulin products. Manufacturers are under attack for price hikes. There are allegations of backroom rebate deals. And a class-action lawsuit has been brought on behalf of uninsured patients, charging insulin makers with setting artificially high prices.
April 2017: Managed Care
https://www.readbyqxmd.com/read/28485557/when-the-treatment-becomes-the-problem
#13
Vivek-Thomas J Sankoorikal, Janet Ricks
A 47-year-old white male with a 5-year history of type 2 diabetes mellitus presented to clinic with uncontrolled hyperglycemia, weight loss, and body aches that impeded his ability to work and sleep. He had initially controlled his diabetes successfully with weight loss and exercise. However, in the previous 6 months he had noticed unintentional weight loss. He was evaluated at another clinic where he was prescribed sitagliptin/metformin (Janumet) for his uncontrolled hyperglycemia. After 6 weeks his blood glucose had not significantly improved, and an endocrinologist prescribed insulin glargine (Lantus) and insulin aspart (NovoLog)...
July 2016: Journal of the Mississippi State Medical Association
https://www.readbyqxmd.com/read/28439129/ismp-medication-error-report-analysis-betaine-anhydrous-versus-betaine-hydrochloride-look-alike-generic-names-don-t-give-zurampic-without-allopurinol-lantus-overdose-tied-to-confusing-vial-label-more-on-lipid-rescue
#14
Michael R Cohen, Judy L Smetzer
These medication errors have occurred in health care facilities at least once. They will happen again-perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting them at your inservice training programs. Your assistance is required to continue this feature. The reports described here were received through the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program...
March 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28361463/clinical-outcomes-of-patients-with-diabetes-who-exhibit-upper-quartile-insulin-antibody-responses-after-treatment-with-ly2963016-or-lantus-%C3%A2-insulin-glargine
#15
Liza L Ilag, Timothy M Costigan, Mark A Deeg, Robyn K Pollom, Curtis L Chang, Robert J Konrad, Melvin J Prince
INTRODUCTION: We compared insulin antibody response (IAR) profiles in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who received LY2963016 insulin glargine (LY IGlar) or Lantus(®) insulin glargine (IGlar) and evaluated the potential relationship between higher IARs and clinical and safety outcomes with a focus on patients who exhibited antibody responses in the upper quartile. METHODS: Data from ELEMENT-1 (52-week open-label in T1D) and ELEMENT-2 (24-week, double-blind study in T2D) were analyzed...
June 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/27669747/assessment-of-three-fasting-plasma-glucose-targets-for-insulin-glargine-based-therapy-in-people-with-type-2-diabetes-mellitus-in-china-study-protocol-for-a-randomized-controlled-trial
#16
Wenying Yang, Zhaojun Yang, Jing Zhao, Hai Lu, Tianhong Luo
BACKGROUND: A large proportion of patients with T2DM in China do not meet accepted HbA1c targets despite the availability of guidelines that describe a treatment pathway for achieving glycemic control. The aim of this study is to identify the fasting plasma glucose (FPG) target that will provide the highest control rate of HbA1c <7 % in Chinese patients with T2DM treated with an insulin glargine-based regimen as an adjunct to an established OAD regimen. This information will support improvements in diabetes care management in China...
September 26, 2016: Trials
https://www.readbyqxmd.com/read/27667797/glycemic-control-and-safety-in-chinese-patients-with-type-2-diabetes-mellitus-who-switched-from-premixed-insulin-to-insulin-glargine-plus-oral-antidiabetics-a-large-prospective-observational-study
#17
MULTICENTER STUDY
Bo Zhang, Jing Zhao, Wenying Yang
In some circumstances, the premixed insulin should be switched to alternative therapy. The effectiveness and the safety of switching from premixed insulin to insulin glargine plus oral antidiabetic drugs (OADs) in Chinese patients with type 2 diabetes mellitus (T2DM) have not been clarified and, hence, will be assessed in this study. Chinese patients with T2DM (2013 men and women aged 18-75 years) who had received premixed insulin ± OADs for ≥3 months with glycated hemoglobin (HbA1c) ≤ 10% were enrolled in a prospective, observational study conducted at 53 hospitals across China...
March 2017: Diabetes/metabolism Research and Reviews
https://www.readbyqxmd.com/read/27484286/duration-of-action-of-two-insulin-glargine-products-ly2963016-insulin-glargine-and-lantus-insulin-glargine-in-subjects-with-type-1-diabetes-mellitus
#18
RANDOMIZED CONTROLLED TRIAL
Helle Linnebjerg, Eric Chen Quin Lam, Xin Zhang, Mary E Seger, David Coutant, Laiyi Chua, Christoph Kapitza, Tim Heise
AIMS: LY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products manufactured by distinct processes, but with identical amino acid sequences. This study compared the duration of action of LY IGlar and IGlar in subjects with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This was a randomized, double-blind, single-dose, two-period, crossover study. Twenty subjects underwent 42-hour euglycaemic clamps after a single subcutaneous 0.3-U/kg dose of LY IGlar or IGlar...
January 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27438706/cost-effectiveness-of-ideglira-vs-alternative-basal-insulin-intensification-therapies-in-patients-with-type-2-diabetes-mellitus-uncontrolled-on-basal-insulin-in-a-uk-setting
#19
COMPARATIVE STUDY
Melanie J Davies, Divina Glah, Barrie Chubb, Gerasimos Konidaris, Phil McEwan
OBJECTIVES: Once-daily insulin degludec/liraglutide (IDegLira) is the first basal insulin and glucagon like peptide-1 receptor agonist combined in one delivery device. Our aim was to investigate the cost effectiveness of IDegLira vs. basal insulin intensification therapies for patients with type 2 diabetes mellitus uncontrolled on basal insulin (glycosylated haemoglobin; HbA1c >7.5 %; 58 mmol/mol) in a UK setting. RESEARCH DESIGN AND METHODS: Baseline cohort and clinical parameters were sourced from a pooled analysis comparing IDegLira with basal insulin plus liraglutide and basal-bolus therapy, and from the DUAL™ V trial comparing IDegLira with up-titrated insulin glargine (IGlar; Lantus(®))...
September 2016: PharmacoEconomics
https://www.readbyqxmd.com/read/27307429/basal-insulin-regime-change-from-lantus-to-toujeo-resulted-in-fewer-hypoglycaemic-episodes-in-a-28-year-old-man-with-diabetes-mellitus
#20
Alexandra Shields, Sailesh Sankaranarayanan
An active 28-year-old man with type 1 diabetes mellitus reported a reduced number of hypoglycaemic episodes following change in basal regime insulin glargine from U100 Lantus to U300 Toujeo. Consequently, an improved quality of life was also reported. Flash-based glucose monitoring was utilised to record 24-hour continuous glucose levels throughout two comparable 60-day periods before and after the change in regimen. Low blood glucose was most likely between 03:00 and 08:00. Nocturnal hypoglycaemic episodes (≤3...
June 15, 2016: BMJ Case Reports
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