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https://www.readbyqxmd.com/read/29915923/pharmacokinetics-and-clinical-implications-of-semaglutide-a-new-glucagon-like-peptide-glp-1-receptor-agonist
#1
REVIEW
Sylvie Hall, Diana Isaacs, Jennifer N Clements
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) came to market in the year 2005, as a new therapeutic classification, for clinical use in the management of type 2 diabetes mellitus (T2DM). Since 2005, there have been six approved products on the market, with the newest product being semaglutide (Novo Nordisk). Several studies have been conducted and completed evaluating its pharmacokinetics as a once-weekly subcutaneous injection. As a dose of 0.5 or 1 mg, semaglutide has a half-life of 7 days; therefore, it would reach steady state in 4-5 weeks...
June 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29915021/lixisenatide-versus-insulin-glulisine-on-fasting-and-postbreakfast-systemic-hemodynamics-in-type-2-diabetes-mellitus-patients
#2
Lennart Tonneijck, Marcel H A Muskiet, Jos W Twisk, Mark H H Kramer, A H Jan Danser, Jaap A Joles, Mark M Smits, Daniël H van Raalte
The prolonged treatment effects of a short-acting GLP-1RA (glucagon-like peptide-1 receptor agonist), such as lixisenatide, on fasting and postprandial systemic hemodynamics in type 2 diabetes mellitus patients are unknown. In this secondary analysis, we included 34 overweight insulin glargine-treated type 2 diabetes mellitus patients (mean±SD age, 62±7 years; HbA1c , 8.0±0.9%; systolic blood pressure [BP], 133.9±16.1 mm Hg; diastolic BP, 75.4±8.39 mm Hg) that were randomized to once-daily lixisenatide 20 μg or once-daily titrated insulin glulisine for 8 weeks...
June 18, 2018: Hypertension
https://www.readbyqxmd.com/read/29910024/dulaglutide-versus-insulin-glargine-in-patients-with-type-2-diabetes-and-moderate-to-severe-chronic-kidney-disease-award-7-a-multicentre-open-label-randomised-trial
#3
Katherine R Tuttle, Mark C Lakshmanan, Brian Rayner, Robert S Busch, Alan G Zimmermann, D Bradley Woodward, Fady T Botros
BACKGROUND: Many antihyperglycaemic drugs, including insulin, are primarily cleared by the kidneys, restricting treatment options for patients with kidney disease. Dulaglutide is a long-acting glucagon-like peptide-1 receptor agonist that is not cleared by the kidneys, and confers a lower risk of hypoglycaemia than does insulin. We assessed the efficacy and safety of dulaglutide in patients with type 2 diabetes and moderate-to-severe chronic kidney disease. METHODS: AWARD-7 was a multicentre, open-label trial done at 99 sites in nine countries...
June 14, 2018: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29895556/a-randomized-controlled-trial-comparing-efficacy-and-safety-of-insulin-glargine-300-units-ml-versus-100-units-ml-in-older-people-with-type-2-diabetes-results-from-the-senior-study
#4
Robert Ritzel, Stewart B Harris, Helen Baron, Hermes Florez, Ronan Roussel, Melanie Espinasse, Isabel Muehlen-Bartmer, Nianxian Zhang, Monica Bertolini, Claire Brulle-Wohlhueter, Medha Munshi, Geremia B Bolli
OBJECTIVE: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes. RESEARCH DESIGN AND METHODS: SENIOR was an open-label, two-arm, parallel-group, multicenter phase 3b trial designed to enroll ∼20% of participants aged ≥75 years. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to a fasting self-monitored plasma glucose of 5...
June 12, 2018: Diabetes Care
https://www.readbyqxmd.com/read/29893144/reduced-glucose-variability-with-glucose-dependent-versus-glucose-independent-therapies-despite-similar-glucose-control-and-hypoglycemia-rates-in-a-randomized-controlled-study-of-older-patients-with-type-2-diabetes-mellitus
#5
Richard E Pratley, Julio Rosenstock, Simon R Heller, Alan Sinclair, Robert J Heine, Jacek Kiljański, Cynthia S Brusko, Ran Duan, Andreas Festa
BACKGROUND: Few studies have evaluated continuous glucose monitoring (CGM) in older patients with type 2 diabetes mellitus (T2DM) not using injectable therapy. CGM is useful for investigating hypoglycemia and glycemic variability, which is associated with complications in T2DM. METHODS: A CGM substudy of Individualized treatMent aPproach for oldER patIents in a randomized trial in type 2 diabetes Mellitus (IMPERIUM)) was conducted. Patients were vulnerable (moderately ill and/or frail) older (≥65 years) individuals with suboptimally controlled T2DM...
June 1, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/29892561/reduction-of-glycemic-variability-with-degludec-insulin-in-patients-with-unstable-diabetes
#6
Diana Cristina Henao-Carrillo, Oscar M Muñoz, Ana M Gómez, Martín Rondón, Christian Colón, L Chica, Claudia Rubio, Fabián León-Vargas, Maria Alejandra Calvachi, Ana María Perea
Introduction: Degludec (IDeg) is an ultralong-acting insulin, with stable pharmacodynamic profile which leads to lower fluctuations in glucose levels. The effect of IDeg has not been specifically assessed in patients with unstable diabetes, defined as increased glycemic variability (GV). Methods: A prospective before-after pilot study was conducted, including patients managed at Hospital Universitario San Ignacio in Bogotá, Colombia. The impact of the switch from a Glargine or Detemir insulin to a basal insulin regimen with IDeg for 12 weeks on GV measured by continuous glucose monitoring, on A1c levels, and on the incidence of episodes of global and nocturnal hypoglycemia was assessed in a group of patients with (coefficient of variation >34%) or without increased basal GV using a Generalised Estimating Equation (GEE) analysis...
June 2018: Journal of Clinical & Translational Endocrinology
https://www.readbyqxmd.com/read/29888454/glycaemic-control-hypoglycaemia-and-weight-change-with-insulin-glargine-300-u-ml-versus-insulin-glargine-100-u-ml-in-japanese-adults-with-type-2-diabetes-a-12-month-comparison-by-concomitant-sulphonylurea-and-or-glinide-use
#7
Yasuo Terauchi, Matthew C Riddle, Takahisa Hirose, Masayoshi Koyama, Xi Cheng, Yoshinori Takahashi, Geremia B Bolli
AIM: To explore if clinical effects and hypoglycaemia risks associated with insulin glargine 300 U/mL (Gla-300) and 100 U/mL (Gla-100) differed by sulphonylurea and/or glinide (SU/G) treatment. METHODS: This was a post hoc subgroup analysis of 12-month treatment data from EDITION JP 2 (randomised, open-label, phase 3 study of Japanese people with type 2 diabetes [T2DM] receiving once-daily Gla-300/Gla-100+oral antihyperglycaemic drugs). Participants previously receiving SU/G (+SU/G) were compared with those not taking SU/G (-SU/G)...
June 11, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29874257/evaluation-of-the-innate-immunostimulatory-potential-of-originator-and-non-originator-copies-of-insulin-glargine-in-an-in-vitro-human-immune-model
#8
Ernesto Luna, Pankaj Agrawal, Riyaz Mehta, Maria E Boone, Charlotte Vernhes, Colombe Denys, Robert Small, Bhaswati Mukherjee, Norbert Tennagels, Stefan Maerten, Donald R Drake
BACKGROUND: The manufacture of insulin analogs requires sophisticated production procedures which can lead to differences in the structure, purity, and/or other physiochemical properties of resultant products that can affect their biologic activity. Here, we sought to compare originator and non-originator copies of insulin glargine for innate immune activity and mechanisms leading to differences in these response profiles in an in vitro model of human immunity. METHODS: An endothelial/dendritic cell-based innate immune model was used to study antigen-presenting cell activation, cytokine secretion, and insulin receptor signalling pathways induced by originator and non-originator insulin glargine products...
2018: PloS One
https://www.readbyqxmd.com/read/29873004/safety-and-efficacy-of-high-versus-standard-starting-doses-of-insulin-glargine-in-overweight-and-obese-chinese-individuals-with-type-2-diabetes-mellitus-inadequately-controlled-on-oral-antidiabetic-medications-beyond-vii-study-protocol-for-a-randomized-controlled
#9
Linong Ji, Zhengnan Gao, Bimin Shi, Rongwen Bian, Fuzai Yin, Wuyan Pang, Hong Gao, Nan Cui
BACKGROUND: Treatment with basal insulin in Chinese populations is currently sub-optimal, with delayed initiation of insulin treatment and inadequate dose titration. Increasing the initial dose of insulin may be a practicable and effective solution to the problem of titration. A higher initial dose will be helpful for patients to achieve the blood glucose target and improve treatment satisfaction and compliance as well require fewer steps to titrate. Considering that overweight and obese patients usually require higher insulin doses because of insulin resistance, a higher initial dose of the basal insulin is feasible in overweight and obese patients with type 2 diabetes...
June 5, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29862621/achieving-glycaemic-control-without-weight-gain-hypoglycaemia-or-gastrointestinal-adverse-events-in-type-2-diabetes-in-the-sustain-clinical-trial-programme
#10
J Hans DeVries, Cyrus Desouza, Srikanth Bellary, Jeffrey Unger, Oluf K H Hansen, Jeppe Zacho, Vincent Woo
AIM: To evaluate the potential for semaglutide to help subjects with type 2 diabetes (T2D) achieve HbA1c targets while avoiding unwanted outcomes such as weight gain, hypoglycaemia and gastrointestinal (GI) side effects. MATERIALS AND METHODS: Data from the phase 3a SUSTAIN 1-5 clinical trials were analysed. Subjects had inadequately controlled T2D and were drug-naïve (SUSTAIN 1) or on a range of background treatments (SUSTAIN 2-5). The main protocol-specified composite endpoint was the proportion of subjects achieving HbA1c <7...
June 4, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29862021/switching-from-biosimilar-basalin-to-originator-lantus-insulin-glargine-is-effective-in-chinese-patients-with-diabetes-mellitus-a-retrospective-chart-review
#11
Xia Hu, Lei Zhang, Yanhu Dong, Chao Dong, Jikang Jiang, Weiguo Gao
Background: This study investigated the effectiveness and safety of switching from Basalin® to Lantus® in Chinese patients with diabetes mellitus (DM). Methods:  A retrospective chart review conducted using the electronic medical records of patients hospitalized at the Qingdao Endocrine and Diabetes Hospital from 2005 to 2016. All patients were diagnosed with DM and underwent switching of insulin from Basalin to Lantus during hospitalization. Data collected included fasting (FBG), pre- and post-prandial whole blood glucose, insulin dose, reasons for insulin switching and hypoglycemia...
2018: F1000Research
https://www.readbyqxmd.com/read/29861115/-effectiveness-of-an-intervention-strategy-in-the-biosimilar-glargine-prescription-pattern-in-primary-care
#12
Carmen Saborido-Cansino, Bernardo Santos-Ramos, Carmen Carmona-Saucedo, María Victoria Rodríguez-Romero, Antonio González-Martín, Ana Palma-Amaro, Isabel María Rojas-Lucena, Carmen Almeida-González, Susana Sánchez-Fidalgo
OBJECTIVES: To examine the effects of specific interventions on biosimilar glargine insulin (BGI) prescribing in general practices and to analyse the influence of prescriber and economic impact. DESIGN: Non randomized controlled study. SETTING: General practices in 2 health areas of Seville, intervention and control group. PARTICIPANTS: 220 general practices (intervention group) and 100 general practices (control group)...
May 31, 2018: Atencion Primaria
https://www.readbyqxmd.com/read/29808361/successful-management-of-poorly-controlled-type-2-diabetes-with-multidisciplinary-neurobehavioral-rehabilitation-a-case-report-and-review
#13
Zhihui Deng, John Davis, Flor Muniz-Rodriguez, Fran Richardson
Lifestyle modification with healthy diet and physical exercise is considered the basic strategy of prevention and treatment of type 2 diabetes, a commonly seen comorbidity in patients with acquired brain injury. Additionally, emotional stress with anxiety and depression is suggested to play a role in type 2 diabetes. Research studies have demonstrated the efficacy of multidisciplinary lifestyle intervention in patients with inadequate glycemic control. However, whether lifestyle approaches alone may be adequate for the management of poorly controlled type 2 diabetes is unknown...
May 28, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29807104/dapagliflozin-improves-blood-glucose-in-diabetes-on-triple-oral-hypoglycemic-agents-having-inadequate-glucose-control
#14
Hyun Jeong Jeon, Eu Jeong Ku, Tae Keun Oh
AIMS: The aim of this study was to evaluate whether a combination drug therapy that consists of dapagliflozin with three other oral hypoglycemic agents (OHAs) would have a beneficial safety and efficacy profile in T2DM patients who have uncontrolled glucose levels compared to a treatment regimen that contains of basal insulin with two different OHAs. METHODS: A total of 162 type 2 diabetic patients who are unable to control glucose on their current therapy consisting of 3 OHAs were enrolled in dapagliflozin group and 148 patients in insulin glargine group for the 24-week study period...
May 26, 2018: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29801995/prevalence-of-insulin-glargine-vial-use-beyond-28-days-in-a-medicaid-population
#15
Judith M Turner, Elizabeth J Unni, Jennifer Strohecker, Jacob Henrichs
OBJECTIVES: Insulin glargine, one of the most commonly prescribed drugs for diabetes, has a 28-day limit on the use of a 10-mL (1000 units) multiple-dose vial once the bottle is punctured. If patients who are using smaller doses or are not adherent continue to use insulin glargine beyond the 28-day window, it can result in questionable stability and sterility of the product. The aim of this study was to determine the proportion of patients who used each insulin glargine vial for more than 28 days, the mean number of days the vial was used after 28 days, the reason for the extended use, and whether that use had any association with diabetes control and injection site infection...
May 22, 2018: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/29797389/management-of-type-2-diabetes-with-fixed-ratio-combination-insulin-degludec-liraglutide-ideglira-versus-basal-bolus-therapy-insulin-glargine-u100-plus-insulin-aspart-a-short-term-cost-effectiveness-analysis-in-the-uk-setting
#16
R S Drummond, Sjp Malkin, M Du Preez, X Y Lee, B Hunt
AIMS: Insulin degludec/liraglutide (IDegLira) is a once-daily, single-injection, fixed-ratio combination of insulin degludec, a basal insulin with a half-life of more than 24 hours, and GLP-1 receptor agonist liraglutide. The present analysis evaluated the cost-effectiveness of IDegLira versus basal-bolus therapy (BBT) with insulin glargine U100 plus up to four times daily insulin aspart for management of type 2 diabetes in the UK. MATERIALS AND METHODS: A Microsoft Excel model was used to evaluate the cost-utility of IDegLira versus BBT over a 1-year time horizon...
May 24, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29796928/multinational-consensus-insulin-initiation-with-insulin-degludec-aspart-idegasp
#17
REVIEW
Sanjay Kalra, Stephen Atkin, Antonio Cervera, Ashok Kumar Das, Orgur Demir, Tevfik Demir, Md Fariduddin, Khoa Tuan Vo, Bon Jeong Ku, Ajay Kumar, Zafar A Latif, Rachid Malek, Bien J Matawaran, Roopa Mehta, Nam Quang Tran, Araceli Panelo, Sundeep Ruder, Joel Rodriquez Saldana, Khalid A Shaikh, Amit Shakya, Dina Shrestha, A G Unnikrishnan
Insulin degludec/aspart (IDegAsp) is the first soluble insulin co-formulation, combining a long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). In type 2 diabetes patients with oral antidiabetes agent (OAD) inadequacy, insulin initiation with IDegAsp once daily provides superior long-term glycemic control compared to insulin glargine, with similar fasting plasma glucose (FPG) and insulin doses, and numerically lower rates of overall and nocturnal hypoglycemia. Furthermore, in patients with uncontrolled type 2 diabetes previously treated with insulins, IDegAsp twice daily effectively improves glycated hemoglobin and FPG, with fewer hypoglycemic episodes versus premix insulins and basal bolus therapy...
May 23, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29796245/the-role-of-basal-insulin-and-glp-1-receptor-agonist-combination-products-in-the-management-of-type-2-diabetes
#18
REVIEW
Taylor R Inman, Erika Plyushko, Nicholas P Austin, Jeremy L Johnson
The prevalence of type 2 diabetes necessitates the development of new treatment options to individualize therapy. Basal insulin has been a standard treatment option for years, while glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have grown in use over the past decade due to glucose-lowering efficacy and weight loss potential. There are two new combination injectable products that have recently been approved combining basal insulins with GLP-1 RAs in single pen-injector devices. United States guidelines recently emphasize the option to use combination injectable therapy with GLP-1 RAs and basal insulin once the basal insulin has been optimally titrated as a second- or third-line agent in addition to metformin without reaching the goal A1c...
May 2018: Therapeutic Advances in Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29793353/developing-planning-and-conducting-an-interim-analysis-lessons-from-the-devote-cardiovascular-outcomes-trial-trial-comparing-cardiovascular-safety-of-insulin-degludec-versus-insulin-glargine-in-patients-with-type-2-diabetes-at-high-risk-of-cardiovascular-events
#19
Hanne Theilgaard, Inger Mollerup, Ida Carøe Helmark, Lars Endahl, Shawn Hoskin, Anders Hvelplund, Lene Klixbüll Amby, Alan C Moses
BACKGROUND: In 2013, a randomized, double-blind, active comparator-controlled, event-driven cardiovascular outcomes trial (DEVOTE) was initiated to compare the cardiovascular safety of insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes at high risk of cardiovascular events. The FDA agreed that an interim analysis could form the basis for an early regulatory approval. We report here the operational model developed to support the DEVOTE interim analysis and the results...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29785837/more-patients-reach-glycaemic-control-with-fixed-ratio-combination-of-insulin-glargine-and-lixisenatide-iglarlixi-than-with-basal-insulin-at-12-weeks-of-treatment-a-post-hoc-time-to-control-analysis-of-lixilan-o-and-lixilan-l
#20
Juan Frias, Manuel Puig Domingo, Luigi Meneghini, Raffaele Napoli, Minzhi Liu, Erika Soltes Rak, Vanita R Aroda
This post hoc analysis of two 30-week clinical trials compared efficacy and hypoglycaemia outcomes at early study visits with iGlarLixi (insulin glargine U100 [iGlar] and lixisenatide) vs iGlar alone in patients with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs; LixiLan-O) or basal insulin (LixiLan-L). Time to control, defined as days to achieve glycated haemoglobin (HbA1c) <7% or fasting plasma glucose (FPG) ≤7.2 mmol/L, was estimated using the Kaplan-Meier method. In LixiLan-O and -L, 60% and 46% of patients, respectively, reached HbA1c <7% with iGlarLixi at 12 weeks, vs 45% and 24%, respectively, with iGlar...
May 21, 2018: Diabetes, Obesity & Metabolism
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