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Insuline Glargin

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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/29430801/dulaglutide-1-5-mg-as-an-add-on-option-for-patients-uncontrolled-on-insulin-subgroup-analysis-by-age-duration-of-diabetes-and-baseline-hba1c
#2
Kevin M Pantalone, Hiren Patel, Maria Yu, Laura Fernández Landó
AIMS: To assess efficacy and safety of dulaglutide 1.5 mg combined with insulin, categorised by subgroups of baseline HbA1c (≤9% and >9%), age (<65 and ≥65 years), and duration of diabetes (<10 and ≥10 years) at 6 months in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: This pooled analysis was conducted in a similar T2D population from the AWARD-4 and AWARD-9 clinical trials randomised to dulaglutide 1.5 mg (pooled mean baseline age: 59 years, duration of diabetes: 13 years, HbA1c: 8...
February 12, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29423761/comparative-safety-and-efficacy-of-insulin-degludec-with-insulin-glargine-in-type-2-and-type-1-diabetes-a-meta-analysis-of-randomized-controlled-trials
#3
Xiao-Wen Zhang, Xin-Lin Zhang, Biao Xu, Li-Na Kang
AIMS: To determine the safety and efficacy of insulin degludec versus glargine in patients with type 1 (T1D) and type 2 (T2D) diabetes mellitus. METHODS: Databases were searched until July 5, 2017. We included randomized controlled trials comparing degludec with glargine in diabetic patients, each with a minimum of 16 weeks of follow-up. RESULTS: Eighteen trials with 16,791 patients were included. Degludec was associated with a statistically significant reduction in risk for all confirmed hypoglycemia at the maintenance treatment period [estimated rate ratio (ERR) 0...
February 8, 2018: Acta Diabetologica
https://www.readbyqxmd.com/read/29413582/determination-of-human-insulin-in-dog-plasma-by-a-selective-liquid-chromatography-tandem-mass-spectrometry-method-application-to-a-pharmacokinetic-study
#4
Shiqi Dong, Yong Zeng, Guangli Wei, Duanyun Si, Changxiao Liu
A simple, sensitive and selective LC-MS/MS method for quantitative analysis of human insulin was developed and validated in dog plasma. Insulin glargine was used as the internal standard. After a simple step of solid-phase extraction, the chromatographic separation of human insulin was achieved by using InertSustain Bio C18 column with a mobile phase of acetonitrile containing 1% formic acid (A)-water containing 1% formic acid (B). The detection was performed by positive ion electrospray ionization in multiple-reaction monitoring (MRM) mode...
January 31, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29406841/slow-titration-and-delayed-intensification-of-basal-insulin-among-patients-with-type-2-diabetes
#5
Michelle Mocarski, Jason Yeaw, Victoria Divino, Mitch DeKoven, German Guerrero, Jakob Langer, Brian Larsen Thorsted
BACKGROUND: Clinical inertia in type 2 diabetes mellitus (T2DM) refers to the failure of clinicians to intensify therapy when indicated. Many T2DM patients remain suboptimally controlled after initiating basal insulin. OBJECTIVE: To examine the prevalence of patients treated with basal insulin but in poor glycemic control (hemoglobin A1c [A1c] ≥ 7%) after initiation and subsequent treatment intensification patterns and glycemic outcomes in a real-world setting...
November 16, 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29381818/role-of-omalizumab-in-insulin-hypersensitivity-a-case-report-and-review-of-the-literature
#6
S Mishra, L Connors, B Tugwell
BACKGROUND: Insulin allergy is a rare yet severe side effect of exogenous insulin use. Management typically involves use of alternative antihyperglycaemic agents, symptom control with antihistamines, use of different insulin formulations, and induction of tolerance with incremental doses of insulin. This treatment regimen is not always successful, and the use of omalizumab, an anti-IgE monoclonal antibody, has been used to induce tolerance to insulin. CASE REPORT: G...
January 30, 2018: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/29380268/rapid-characterization-of-insulin-modifications-and-sequence-variations-by-proteinase-k-digestion-and-uhplc-esi-ms
#7
Rong-Sheng Yang, Weijuan Tang, Huaming Sheng, Fanyu Meng
Discovery of novel insulin analogs as therapeutics has remained an active area of research. Compared with native human insulin, insulin analog molecules normally incorporate either covalent modifications or amino acid sequence variations. From the drug discovery and development perspective, methods for efficient and detailed characterization of these primary structural changes are very important. In this report, we demonstrate that proteinase K digestion coupled with UPLC-ESI-MS analysis provides a simple and rapid approach to characterize the modifications and sequence variations of insulin molecules...
January 29, 2018: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/29377408/a-2-year-trial-of-intermittent-insulin-therapy-versus-metformin-for-the-preservation-of-beta-cell-function-after-initial-short-term-intensive-insulin-induction-in-early-type-2-diabetes
#8
Ravi Retnakaran, Haysook Choi, Chang Ye, Caroline K Kramer, Bernard Zinman
AIMS: When administered in early type 2 diabetes (T2DM), short-term intensive insulin therapy (IIT) can improve reversible beta-cell dysfunction and induce subsequent remission of diabetes. However, this remission is ultimately temporary, as beta-cell function deteriorates over time after stopping IIT. Thus, to preserve beta-cell function, we hypothesized that "induction" IIT needs to be followed by a "maintenance therapy." In this context, we sought to evaluate the impact on beta-cell function over 2-years of two approaches to maintenance therapy: intermittent short-term IIT every 3-months versus daily metformin...
January 27, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29370218/the-effect-of-concomitant-dppivi-use-on-glycaemic-control-and-hypoglycaemia-with-insulin-glargine-300-u-ml-gla-300-versus-insulin-glargine-100-u-ml-gla-100-in-people-with-type-2-diabetes-a-patient-level-meta-analysis-of-edition-2-and-3
#9
Jean-François Yale, Jeremy Hodson Pettus, Miguel Brito-Sanfiel, Fernando Lavalle-Gonzalez, Ana Merino-Trigo, Peter Stella, Soazig Chevalier, Raffaella Buzzetti
AIMS: To evaluate the effect of concomitant dipeptidyl peptidase IV inhibitor (DPPIVi) use on efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in people with type 2 diabetes on oral antihyperglycaemic drugs. METHODS: A post hoc patient-level meta-analysis was performed using data from EDITION 2 (basal insulin [N = 811]) and EDITION 3 (insulin-naïve [N = 878]), multicentre, randomised, open-label, parallel-group, phase 3a trials of similar design...
2018: PloS One
https://www.readbyqxmd.com/read/29368288/ly2963016-insulin-glargine-a-review-in-type-1-and-2-diabetes
#10
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/29357718/the-cost-effectiveness-of-dulaglutide-versus-insulin-glargine-for-the-treatment-of-type-2-diabetes-mellitus-in-japan
#11
Hitoshi Ishii, Matthew Madin-Warburton, Alena Strizek, Lucy Thornton-Jones, Shuichi Suzuki
AIMS: Dulaglutide is a new once weekly glucagon-like peptide-1 (GLP-1) receptor agonist administered via a disposable auto-injection pen for the management of type 2 diabetes mellitus (T2DM). The objective of this study was to estimate the cost-effectiveness of dulaglutide versus insulin glargine for the management of T2DM from a Japanese healthcare perspective in accordance with recently approved Japanese Cost-Effectiveness Guidelines. METHODS: The IQVIA CORE Diabetes Model (version 9) was used to estimate the long-term costs and effects of treatment with dulaglutide and insulin glargine...
January 22, 2018: Journal of Medical Economics
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
#12
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/29335890/effectiveness-of-sodium-glucose-cotransporter-2-inhibitor-as-an-add-on-drug-to-glp-1-receptor-agonists-for-glycemic-control-of-a-patient-with-prader-willi-syndrome-a-case-report
#13
Yukio Horikawa, Mayumi Enya, Makie Komagata, Ken-Ichi Hashimoto, Masayo Kagami, Maki Fukami, Jun Takeda
INTRODUCTION: Diabetes patients with Prader-Willi syndrome (PWS) are obese because of hyperphagia; weight control by dietary modification and medicine is required for glycemic control. There are several recent reports showing the effectiveness of GLP-1 receptor agonists (GLP-1RAs) for diabetes treatment in PWS. CASE REPORT: A 36-year-old Japanese male patient was diagnosed with PWS at 10 years of age. At age 16 years, he was diagnosed with diabetes and began to take several kinds of oral hypoglycemic agents...
January 15, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29322308/quality-of-life-of-patients-with-type-1-diabetes-mellitus-using-insulin-analog-glargine-compared-with-nph-insulin-a-systematic-review-and-policy-implications
#14
REVIEW
Paulo H R F Almeida, Thales B C Silva, Francisco de Assis Acurcio, Augusto A Guerra Júnior, Vania E Araújo, Leonardo M Diniz, Brian Godman, Alessandra M Almeida, Juliana Alvares
INTRODUCTION: Insulin analog glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have shown that a decrease in the frequency of hypoglycemic episodes improves the quality of life (QoL) of diabetic patients. However, there are appreciable acquisition cost differences between different insulins. Consequently, there is a need to assess their impact on QoL to provide future guidance to health authorities...
January 10, 2018: Patient
https://www.readbyqxmd.com/read/29316176/effect-of-prandial-treatment-timing-adjustment-based-on-continuous-glucose-monitoring-in-patients-with-type-2-diabetes-uncontrolled-on-once-daily-basal-insulin-a-randomized-phase-iv-study
#15
Jacob Ilany, Hamad Bhandari, Dan Nabriski, Yoel Toledano, Noa Konvalina, Ohad Cohen
OBJECTIVE: To evaluate the glycemic control achieved by prandial once daily insulin glulisine injection timing adjustment based on continuous glucose monitoring sensor in comparison to once daily insulin glulisine injection before breakfast in type 2 diabetes patients uncontrolled on once daily basal insulin glargine. RESEARCH DESIGN AND METHODS: This was a 24-week open-label, randomized-controlled, multicenter trial. At the end of 8 weeks of basal insulin optimization period, patients with HbA1c ≥ 7...
January 8, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29316143/basal-insulin-peglispro-increases-lipid-oxidation-metabolic-flexibility-thermogenesis-and-ketone-bodies-compared-to-insulin-glargine-in-subjects-with-type-1-diabetes-mellitus
#16
Niels K Porksen, Helle Linnebjerg, Eric Chen Quin Lam, Parag Garhyan, Alok Pachori, Richard E Pratley, Steven R Smith
AIMS: When treated with basal insulin peglispro (BIL), patients with type 1 diabetes mellitus (T1DM) exhibit weight loss and lower prandial insulin requirements versus insulin glargine (GL), while total insulin requirements remain similar. One possible explanation is enhanced lipid oxidation and improved ability to switch between glucose and lipid metabolism with BIL. This study compared the effects of BIL and GL on glucose and lipid metabolism in subjects with T1DM. MATERIALS AND METHODS: Fifteen subjects with T1DM were enrolled into this open-label, randomised, crossover study, and received once-daily stable, individualised, subcutaneous doses of BIL and GL for 4 weeks each...
January 8, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29314667/clinical-characteristics-of-type-2-diabetes-patients-with-discordance-between-hba1c-and-fasting-plasma-glucose-in-the-real-world-an-analysis-of-the-orbit-study
#17
Hua Shu, Juming Lu, Puhong Zhang, Dongshan Zhu, Xian Li, Jiachao Ji, Fang Zhao, Linong Ji
BACKGROUND: We aimed to determine the clinical characteristics of type 2 diabetes patients on basal insulin therapy with inadequate glucose control due to discordance between glycated haemoglobin (HbA1c ) and fasting plasma glucose (FPG) in the real world. METHODS: This was a retrospective analysis of data from the ORBIT study in China. Clinical characteristics of patients with discordance between HbA1c and FPG at baseline and at the end of 6 months of follow-up were analysed using multinomial logistic regression in 4 study groups divided by HbA1c and FPG...
January 3, 2018: Diabetes/metabolism Research and Reviews
https://www.readbyqxmd.com/read/29313285/treatment-dosing-patterns-and-clinical-outcomes-for-patients-with-type-2-diabetes-starting-or-switching-to-treatment-with-insulin-glargine-300-units-per-milliliter-in-a-real-world-setting-a-retrospective-observational-study
#18
Shaloo Gupta, Hongwei Wang, Neil Skolnik, Liyue Tong, Ryan M Liebert, Lulu K Lee, Peter Stella, Anna Cali, Ronald Preblick
INTRODUCTION: Usage patterns and effectiveness of a longer-acting formulation of insulin glargine at a strength of 300 units per milliliter (Gla-300) have not been studied in real-world clinical practice. This study evaluated differences in dosing and clinical outcomes before and after Gla-300 treatment initiation in patients with type 2 diabetes starting or switching to treatment with Gla-300 to assess whether the benefits observed in clinical trials translate into real-world settings...
January 8, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29300101/quality-of-life-and-treatment-satisfaction-in-actual-clinical-practice-of-patients-with-type-1-diabetes-mellitus-t1dm-and-hypoglycemia-treated-with-insulin-degludec
#19
Edurne Lecumberri, Maite Ortega, Marta Iturregui, José Antonio Quesada, Clotilde Vázquez, Domingo Orozco
OBJECTIVE: The frequency of hypoglycemia in patients with T1DM is high and results in a poorer quality of life and low treatment satisfaction. The aim of our study is to demonstrate the effect of changing the basal insulin (glargine or detemir) to insulin degludec. METHODS: We conducted an observational analytical study on a cohort of 110 patients with T1DM. The patients were administered 3 questionnaires to assess treatment satisfaction (DTSQ-s), fear of hypoglycemia (HFS-II) and quality of life (EQ-5D), before the change and at 6 months...
January 4, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29289540/a-randomized-controlled-study-comparing-a-dpp4-inhibitor-linagliptin-and-basal-insulin-glargine-in-patients-with-type-2-diabetes-in-long-term-care-and-skilled-nursing-facilities-linagliptin-ltc-trial
#20
Guillermo E Umpierrez, Saumeth Cardona, David Chachkhiani, Maya Fayfman, Sahebi Saiyed, Heqiong Wang, Priyathama Vellanki, J Sonya Haw, Darin E Olson, Francisco J Pasquel, Theodore M Johnson
OBJECTIVES: Safe and easily implemented treatment regimens are needed for the management of patients with type 2 diabetes mellitus (T2DM) in long-term care (LTC) and skilled nursing facilities. DESIGN: This 6-month open-label randomized controlled trial compared the efficacy and safety of a DPP4 inhibitor (linagliptin) and basal insulin (glargine) in LTC residents with T2DM. SETTINGS: Three LTC institutions affiliated with a community safety-net hospital, US Department of Veterans Affairs and Emory Healthcare System in Atlanta, Georgia...
December 27, 2017: Journal of the American Medical Directors Association
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