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https://www.readbyqxmd.com/read/28537449/understanding-how-pharmacokinetic-and-pharmacodynamic-differences-of-basal-analog-insulins-influence-clinical-practice
#1
Jennifer Goldman, Christoph Kapitza, Jeremy Pettus, Tim Heise
This article reviews pharmacokinetic (PK) and pharmacodynamic (PD) concepts relating to the pharmacology of basal insulin analogs. Understanding the pharmacology of currently available long-acting basal insulins and the techniques used to assess PK and PD parameters (e.g. the euglycemic clamp method) is important when considering the efficacy and safety of these agents, and can help in understanding the rationale for specific dosing strategies when tailoring therapy for a specific patient. Basal insulins such as insulin glargine 100 units (U)/mL and insulin detemir show improved PK/PD characteristics compared with the intermediate-acting NPH insulin, with a longer duration of action, a more consistent glucose-lowering effect and less prominent concentration peaks...
May 24, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28527305/changes-in-hba1c-and-hypoglycemic-episodes-in-type-1-diabetes-patients-after-switching-to-insulin-glargine-u300-pilot-study
#2
Marina Gradišer, Maja Cigrovski Berković, Ines Bilić-Ćurčić
We included diabetes type 1 (T1DM) patients with suboptimal glycemic control on morning application glargine (I-Glar) U100, switching them to U300. After six months improvement in HbA1c was observed, while hypoglycemic episodes decreased. Switch from I-Glar U100 to U300 could be a good therapeutic option for that subset of patients.
May 9, 2017: Diabetes Research and Clinical Practice
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
#3
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 16, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28526033/effects-of-exenatide-on-cardiac-function-perfusion-and-energetics-in-type-2-diabetic-patients-with-cardiomyopathy-a-randomized-controlled-trial-against-insulin-glargine
#4
Weena J Y Chen, Michaela Diamant, Karin de Boer, Hendrik J Harms, Lourens F H J Robbers, Albert C van Rossum, Mark H H Kramer, Adriaan A Lammertsma, Paul Knaapen
BACKGROUND: Multiple bloodglucose-lowering agents have been linked to cardiovascular events. Preliminary studies showed improvement in left ventricular (LV) function during glucagon-like peptide-1 receptor agonist administration. Underlying mechanisms, however, are unclear. The purpose of this study was to investigate myocardial perfusion and oxidative metabolism in type 2 diabetic (T2DM) patients with LV systolic dysfunction as compared to healthy controls. Furthermore, effects of 26-weeks of exenatide versus insulin glargine administration on cardiac function, perfusion and oxidative metabolism in T2DM patients with LV dysfunction were explored...
May 19, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28526014/the-use-of-lipid-lowering-therapy-and-effects-of-antihyperglycaemic-therapy-on-lipids-in-subjects-with-type-2-diabetes-with-or-without-cardiovascular-disease-a-pooled-analysis-of-data-from-eleven-randomized-trials-with-insulin-glargine-100%C3%A2-u-ml
#5
Markolf Hanefeld, Louise Traylor, Ling Gao, Wolfgang Landgraf
BACKGROUND: Dyslipidaemia is a major contributor to the increased risk of cardiovascular disease (CVD) associated with type 2 diabetes (T2D). This study aimed to characterize the extent of lipid-lowering therapy use and its impact on lipid and glycaemic outcomes in people with T2D uncontrolled on oral agents who were enrolled in insulin glargine 100 units/mL (Gla-100) randomized controlled trials (RCTs). METHODS: A post hoc patient-level pooled analysis of eleven RCTs (≥24 weeks' duration) comparing Gla-100 (±oral antidiabetes drugs [OADs]) with OADs alone in people with T2D was performed...
May 19, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28524340/effectiveness-and-clinical-inertia-in-patients-with-antidiabetic-therapy
#6
Manuel Enrique Machado-Duque, Adriana Carolina Ramírez-Riveros, Jorge Enrique Machado-Alba
AIMS: To establish the effectiveness of antidiabetic therapy and the frequency of clinical inertia in the management of type 2 diabetes mellitus in Colombia. METHODS: A cross-sectional study with follow-up of patients who had been treated for at least 1 year and were receiving medical consultation for antidiabetic treatment. Effectiveness was established when haemoglobin-A1c levels were <7% and when clinical inertia was reached, which was defined as no therapeutic modifications despite not achieving management controls...
May 19, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28523624/erratum-to-evaluation-of-the-short-term-cost-effectiveness-of-ideglira-versus-continued-up-titration-of-insulin-glargine-u100-in-patients-with-type-2-diabetes-in-the-usa
#7
Barnaby Hunt, Michelle Mocarski, William J Valentine, Jakob Langer
No abstract text is available yet for this article.
May 18, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28523483/modeling-the-long-term-cost-effectiveness-of-ideglira-in-patients-with-type-2-diabetes-who-are-failing-to-meet-glycemic-targets-on-basal-insulin-alone-in-the-netherlands
#8
Barnaby Hunt, Divina Glah, Maarten van der Vliet
INTRODUCTION: Insulin degludec/liraglutide (IDegLira) is the first basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single pen injection device, and a once-daily treatment option for patients with type 2 diabetes mellitus (T2DM) who are uncontrolled on basal insulin and require treatment intensification. The objective of this analysis was to evaluate the long-term cost-effectiveness of IDegLira versus basal-bolus therapy (insulin glargine U100 + 3× daily insulin aspart) for patients with T2DM uncontrolled on basal insulin [HbA1c >53 mmol/mol (>7%)] in the Netherlands...
May 18, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28511140/different-impacts-of-acylated-and-non-acylated-long-acting-insulin-analogs-on-neural-functions-in-vitro-and-in-vivo
#9
Hiroshi Tsuneki, Hitomi Yoshida, Kosuke Endo, Norihiko Mori, Shuji Hosoh, Masaaki Tsuda, Tsutomu Wada, Toshiyasu Sasaoka
AIMS: Centrally administered insulin improves cognitive functions in patients with Alzheimer's disease; however, it remains unknown whether long-acting insulin analogs exert more pronounced effects than insulin. In the present study, we directly compared the effects of insulin and its analogs on neural functions in vitro and in vivo. METHODS: Cultured rat cerebral cortical neurons were treated with insulin, insulin glargine U100 (Gla), insulin detemir (Det), or insulin degludec (Deg)...
May 4, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28491437/hypersensitivity-reaction-associated-with-subcutaneous-glargine-insulin-therapy-in-a-cat
#10
Lisa A Murphy, Greg F Zuendt, Reid K Nakamura, Paul Gambardella
CASE SUMMARY: A 14-year-old, domestic shorthair cat was treated for transient diabetes mellitus for 3 months with glargine insulin, which was discontinued when the diabetes mellitus resolved. Approximately 36 months later the diabetes mellitus recurred and glargine insulin was restarted. Within 2-3 mins of the first injection the cat collapsed, developed profuse vomiting and diarrhea, as well as facial swelling and diffuse erythema. A hypersensitivity reaction was suspected and the cat was treated with antihistamines, aggressive fluid therapy and gastrointestinal support...
July 2016: JFMS Open Rep
https://www.readbyqxmd.com/read/28485557/when-the-treatment-becomes-the-problem
#11
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/28483786/faster-aspart-versus-insulin-aspart-as-part-of-a-basal-bolus-regimen-in-inadequately-controlled-type-2-diabetes-the-onset-2-trial
#12
Keith Bowering, Christopher Case, John Harvey, Michael Reeves, Michael Sampson, Robert Strzinek, Ditte-Marie Bretler, Rikke Beck Bang, Bruce W Bode
OBJECTIVE: This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in adults with type 2 diabetes receiving basal insulin and oral antidiabetic agents. RESEARCH DESIGN AND METHODS: The primary end point was HbA1c change from baseline after 26 weeks' treatment. After an 8-week run-in to optimize basal insulin, subjects were randomized (1:1) to mealtime faster aspart (n = 345) or IAsp (n = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin...
May 8, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28475455/higher-concentration-insulins-an-overview-of-clinical-considerations
#13
Timothy S Reid, Fryn Schafer, Cynthia Brusko
Three higher concentration insulin products (insulin lispro 200 units/mL, insulin degludec 200 units/mL, and insulin glargine 300 units/mL) received US Food and Drug Administration (FDA) approval in 2015. Although human regular insulin 500 units/mL (U-500) was approved in 1997, a pen and dedicated U-500 syringe became available in 2016. These products offer more treatment options for the increasing numbers of patients requiring insulin to achieve and maintain glycemic targets. Higher concentration insulins have some unique safety and efficacy considerations...
May 12, 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/28467113/efficacy-and-safety-of-insulin-glargine-300-u-ml-versus-insulin-glargine-100-u-ml-in-high-risk-and-low-risk-patients-with-type-2-diabetes-stratified-using-common-clinical-performance-measures
#14
Ildiko Lingvay, Jason Chao, Mehul R Dalal, Luigi F Meneghini
BACKGROUND: To determine whether previously reported reductions in hypoglycemia associated with insulin glargine 300 U/mL (Gla-300) compared with insulin glargine 100 U/mL (Gla-100) are impacted by patient risk category in type 2 diabetes (T2D), clinical performance measures based on the Healthcare Effectiveness Data and Information Set (HEDIS) were applied to patient-level data from the EDITION 2 and EDITION 3 clinical trials that compared Gla-300 and Gla-100. METHODS: In this post hoc analysis, patients were stratified as low risk (LR) if patients were <65 years old with no comorbidities derived from HEDIS (HbA1c target <7...
May 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28466661/dose-unit-establishment-for-a-new-basal-insulin-using-joint-modeling-of-insulin-dose-and-glycemic-response
#15
Yongming Qu, Junxiang Luo, Parag Garhyan, Caryl J Antalis, Annette M Chang, Scott J Jacober
BACKGROUND: For new insulin analogs with properties that vary from human insulin, defining activity in units of human insulin based on glycemic lowering efficacy may be challenging. Here we present a new method that can be used to quantify a unit dose of an experimental insulin when the traditional euglycemic clamp method is not adequate. METHODS: Joint modeling of insulin dose and the glycemic outcome variable hemoglobin A1c (HbA1c), where both were response variables, was used to evaluate insulin unit potency for basal insulin peglispro (BIL)...
May 1, 2017: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/28458515/united-states-experience-of-insulin-degludec-alone-or-in-combination-for-type-1-and-type-2-diabetes
#16
REVIEW
Marc Rendell
Insulin degludec has been the product of a sophisticated and systematic biochemical engineering program which began with the release of insulin detemir. The goal was to produce a long-lasting basal insulin with low individual variability. Certainly, this goal has been achieved. Degludec has a duration of action approaching twice that of glargine. Another advantage of degludec is in its lack of unpredictable copolymerization of added aspart. In several studies, degludec has shown lower rates of nocturnal hypoglycemia than glargine...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28452095/cost-effectiveness-of-exenatide-twice-daily-versus-insulin-glargine-as-add-on-therapy-to-oral-anti-diabetic-agents-in-type-2-diabetes-in-china
#17
Shuyan Gu, Xiaoyong Wang, Qing Qiao, Weiguo Gao, Jian Wang, Hengjin Dong
AIMS: This study aimed to estimate long-term cost-effectiveness of exenatide twice daily (EBID) versus insulin glargine once daily (IGQD) as add-on therapy to oral anti-diabetic agents (OADs) for Chinese patients with type 2 diabetes (T2DM). MATERIALS AND METHODS: Cardiff Diabetes Model was used to simulate disease progression and estimate long-term effects of EBID versus IGQD. Model-required patient profiles and treatment effects were obtained from literature reviews (English and Chinese databases) and meta-analysis of eight randomized clinical trials comparing EBID versus IGQD add-on to OADs for T2DM in China...
April 28, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28449412/effects-of-age-gender-and-body-mass-index-on-efficacy-and-hypoglycaemia-outcomes-across-treat-to-target-trials-with-insulin-glargine-100-u-ml-added-to-oral-antidiabetes-agents-in-type-2-diabetes
#18
D Owens, G Bolli, B Charbonnel, T Haak, W Landgraf, F Porcellati, L Traylor, A Kautzky-Willer
AIMS: Analyse effects of patient characteristics and different OAD use on standardised clinical outcomes in type 2 diabetes patients initiating insulin glargine 100 U/ml (Gla-100). MATERIALS AND METHODS: Patient-level data were analysed from 16 randomised, treat-to-target clinical trials that added Gla-100 to existing metformin (MET), sulfonylurea (SU), or metformin plus sulfonylurea (MET+SU) in insulin-naïve patients inadequately controlled on oral therapy and followed for ≥24 weeks...
April 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28449402/postprandial-renal-haemodynamic-effect-of-lixisenatide-versus-once-daily-insulin-glulisine-in-type-2-diabetes-patients-on-insulin-glargine-an-8-week-randomised-open-label-trial
#19
Lennart Tonneijck, Marcel H A Muskiet, Mark M Smits, Trynke Hoekstra, Mark H H Kramer, A H Jan Danser, Michaela Diamant, Jaap A Joles, Daniël H van Raalte
AIMS: To determine whether lixisenatide, a prandial short-acting glucagon-like peptide receptor agonist (GLP-1RA), ameliorates postprandial glomerular hyperfiltration in type 2 diabetes mellitus (T2DM)-patients compared to insulin-glulisine (iGlu) . METHODS: Postprandial renal haemodynamic effects of 8-week treatment with lixisenatide 20 µg versus once-daily titrated iGlu were measured in 35 overweight T2DM-patients inadequately controlled on insulin-glargine, with or without metformin (mean±SD age 62 ± 7years, HbA1c 8...
April 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28442823/insulin-degludec-200-units-ml-is-associated-with-lower-injection-frequency-and-improved-patient-reported-outcomes-compared-with-insulin-glargine-100-units-ml-in-patients-with-type-2-diabetes-requiring-high-dose-insulin
#20
Mark L Warren, Louis B Chaykin, Serge Jabbour, Mae Sheikh-Ali, Charlotte T Hansen, Thor S S Nielsen, Paul Norwood
IN BRIEF Many patients with type 2 diabetes require high basal insulin doses, necessitating multiple injections, increasing patient burden, and resulting in reduced treatment adherence. This randomized, controlled, crossover trial compared the efficacy, safety, and patient-reported outcomes for a concentrated formulation of insulin degludec (200 units/mL) to those of insulin glargine in patients requiring high doses of basal insulin. By offering equivalent glycemic control while reducing the rate of confirmed hypoglycemia and the number of injections required for administration, insulin degludec 200 units/mL may be preferred by patients with type 2 diabetes who require high basal insulin doses...
April 2017: Clinical Diabetes: a Publication of the American Diabetes Association
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