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https://www.readbyqxmd.com/read/27861265/drug-updates-and-approvals-2016-in-review
#1
Lindsy Meadowcraft, Geoffrey Mospan, Taylor Morrisette, Katie Smart, Melissa Janis
In 2016, the FDA approved several new drugs for use in primary care. These drugs include amphetamine extended-release orally disintegrating tablets (Adzenys XR-ODT), elbasvir and grazoprevir (Zepatier), emtricitabine and tenofovir alafenamide (Descovy), glycopyrrolate and formoterol (Bevespi Aerosphere), insulin degludec injection (Tresiba), and ixekizumab (Taltz).
December 16, 2016: Nurse Practitioner
https://www.readbyqxmd.com/read/27853981/intensification-of-idegasp-twice-daily-adding-insulin-aspart-vs-switching-to-basal-bolus-exploratory-randomized-trial-in-type-2-diabetes
#2
Wan Mohamaed Wan Bebakar, Louis Chaykin, Malene Lundgren Hersløv, Søren Rasmussen
INTRODUCTION: In a preceding trial comparing two different titration schemes, insulin degludec/insulin aspart (IDegAsp) showed good efficacy for achieving HbA1c <7% when administered twice daily (BID) in patients with uncontrolled type 2 diabetes (T2D). However, poor glycemic control persisted in a minority of patients. The current exploratory trial investigated the efficacy and safety of intensifying IDegAsp BID treatment in these patients by either adding a once-daily (OD) bolus injection of insulin aspart (IAsp) or by switching to a basal-bolus regimen of insulin degludec (IDeg) plus IAsp taken three times a day (TID)...
November 16, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/27846338/an-evolutionary-perspective-on-basal-insulin-in-diabetes-treatment-innovations-in-insulin-insulin-degludec-u-100-and-u-200
#3
Athena Philis-Tsimikas
Insulin degludec (IDeg) is a long-acting basal human insulin analog produced using recombinant DNA technology. The insulin structure is modified at the B30 position to allow a di-hexamer conformation in the presence of phenol and zinc.
October 2016: Journal of Family Practice
https://www.readbyqxmd.com/read/27836130/insulin-degludec-lixisenatide-and-patiromer-sorbitex-calcium
#4
Daniel A Hussar, Melissa N White
No abstract text is available yet for this article.
November 2016: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/27799746/insulin-glargine-300-u-ml-in-the-management-of-diabetes-clinical-utility-and-patient-perspectives
#5
REVIEW
Bastiaan E de Galan
There is ongoing interest in optimizing basal insulin treatment by developing insulins with a flat pharmacological profile, a long duration of action (typically beyond 24 hours) and minimum day-to-day variation. Glargine-300 is a modified form of the long-acting insulin analog glargine in that it has been concentrated at 300 units/mL rather than the conventional 100 units/mL. Glargine-300 has a longer duration of action and a flatter pharmacological profile than original glargine-100. This property allows for more flexibility around the timing of administration, when injected once per day...
2016: Patient Preference and Adherence
https://www.readbyqxmd.com/read/27764979/budget-impact-of-treating-commercially-insured-type-1-and-type-2-diabetes-patients-in-the-united-states-with-insulin-degludec-compared-to-insulin-glargine
#6
James Weatherall, Lisa Bloudek, Sarah Buchs
OBJECTIVE: To quantify the annual budget impact if all United States (US) commercially insured type 1 diabetes mellitus patients on basal-bolus therapy (T1DMBBT), type 2 diabetes mellitus patients on basal-oral therapy (T2DMBOT), and type 2 diabetes mellitus patients on basal-bolus therapy (T2DMBBT) switched from insulin glargine (IGlar) to insulin degludec (IDeg). METHODS: A short-term (1-year) budget impact model was developed to evaluate the costs of IDeg vs...
October 21, 2016: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/27760129/efficacy-and-safety-of-once-daily-insulin-degludec-insulin-aspart-versus-insulin-glargine-u100-for-52-weeks-in-insulin-na%C3%A3-ve-patients-with-type-2-diabetes-a-randomized-controlled-trial
#7
Ajay Kumar, Edward Franek, Jonathan Wise, Marcus Niemeyer, Henriette Mersebach, Rafael Simó
PURPOSE: The efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily (OD) compared with insulin glargine U100 (IGlar) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus (T2DM) was investigated. METHODS: In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264). Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221)...
2016: PloS One
https://www.readbyqxmd.com/read/27746408/a-randomized-crossover-study-of-the-efficacy-and-safety-of-switching-from-insulin-glargine-to-insulin-degludec-in-children-with-type-1-diabetes
#8
Tatsuhiko Urakami, Yusuke Mine, Masako Aoki, Misako Okuno, Junichi Suzuki
This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues...
October 14, 2016: Endocrine Journal
https://www.readbyqxmd.com/read/27710135/pharmacodynamic-and-pharmacokinetic-evaluation-of-insulin-glargine-u300-for-the-treatment-of-type-1-diabetes
#9
Kathryn M Hurren, Jessica L O'Neill
Glargine 300 units/ml (Gla-300) is a novel basal insulin formulation approved in 2015 for the treatment of diabetes. This more concentrated form of glargine causes delayed redissolution from the subcutaneous depot after injection and thus altered action profile. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of Gla-300 in patients with type 1 diabetes mellitus (T1DM) will be reviewed. Expert opinion: Gla-300 has a flatter and more prolonged pharmacokinetic profile compared to glargine 100 units/ml (Gla-100), but is less potent on a unit per unit basis...
December 2016: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/27705031/a-short-term-cost-utility-analysis-of-insulin-degludec-versus-insulin-glargine-in-patients-with-type-1-or-type-2-diabetes-in-denmark
#10
R F Pollock, C K Tikkanen
BACKGROUND AND AIMS: Insulin degludec is an insulin analog with an ultra-long duration of action that exhibits less intra-patient variability in its glucose-lowering activity, and reduces nocturnal, overall, and severe hypoglycaemia relative to insulin glargine. The aim of the present study was to evaluate the cost-effectiveness of insulin degludec relative to insulin glargine in patients with: type 1 diabetes (T1D), type 2 diabetes receiving basal-only therapy (T2DBOT), and type 2 diabetes receiving basal-bolus therapy (T2DBB) in Denmark...
October 5, 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/27696221/a-review-of-insulin-degludec-insulin-aspart-pharmacokinetic-and-pharmacodynamic-properties-and-their-implications-in-clinical-use
#11
Hanne Haahr, Edmond G Fita, Tim Heise
Insulin degludec/insulin aspart (IDegAsp; 70 % IDeg and 30 % IAsp) is a soluble combination of two individual insulin analogues in one product, designed to provide mealtime glycaemic control due to the IAsp component and basal glucose-lowering effect from the IDeg component. The pharmacokinetic and pharmacodynamic characteristics of IDegAsp have been investigated in a series of clinical pharmacology studies with generally comparable designs, methodologies and patient inclusion/exclusion criteria. The glucose-lowering effect profile of IDegAsp during once-daily dosing at steady state shows distinct and clearly separated action from the prandial and basal components of IDegAsp...
October 1, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27668062/tresiba-insulin-degludec-injection-and-ryzodeg-70-30-insulin-degludec-and-insulin-aspart-injection-two-new-insulin-analogs-for-glycemic-control-in-diabetes-mellitus
#12
https://www.readbyqxmd.com/read/27627074/-clinical-contribution-of-new-basal-analogue-insulin
#13
Alena Adamíková
UNLABELLED: Chronic long term hyperglycemia plays a key role in the pathogenesis of micro and macrovascular complications. The UKPDS study and its further analysis has proved that reduction of the value of glycated hemoglobin by 1 % leads to a 14 % reduction of the risk of myocardial infarction and a 37 % reduction of the risk of microvascular complications. Effective control of glycaemia, optimal value of pre-prandial, postprandial glycaemia, and low variability from the start of the disease has a long term beneficial impact...
2016: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27621510/sacubitril-valsartan
#14
EDITORIAL
Dennis J Cada, Danial E Baker, James Leonard
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
November 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/27618501/switching-from-twice-daily-glargine-or-detemir-to-once-daily-degludec-improves-glucose-control-in-type-1-diabetes-an-observational-study
#15
S Galasso, A Facchinetti, B M Bonora, V Mariano, F Boscari, E Cipponeri, A Maran, A Avogaro, G P Fadini, D Bruttomesso
BACKGROUND AND AIMS: Degludec is an ultralong-acting insulin analogue with a flat and reproducible pharmacodynamic profile. As some patients with type 1 diabetes (T1D) fail to achieve 24-h coverage with glargine or detemir despite twice-daily injections, we studied the effect of switching T1D patients from twice-daily glargine or detemir to degludec. METHODS AND RESULTS: In this prospective observational study, T1D patients on twice-daily glargine or detemir were enrolled...
December 2016: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
https://www.readbyqxmd.com/read/27596552/-efficacy-and-safety-of-insulin-degludec-for-diabetes-mellitus-a-meta-analysis
#16
S M Sun, L Ding, H X Liu, X R Deng, C B Jing, R Z Zheng, Y F Wang
OBJECTIVE: To systematically evaluate the efficacy and safety of insulin degludec for diabetes mellitus (DM). METHODS: Databases including Cochrane Library, PubMed, Embase, Wanfang Data, China Biology Medicine disc (CBM) and China National Knowledge Infrastructure (CNKI) were searched electronically for randomized controlled trials (RCTs) meeting including criteria and the methodological quality of studies was assessed. Then meta-analysis was performed using RevMan 5...
August 23, 2016: Zhonghua Yi Xue za Zhi [Chinese medical journal]
https://www.readbyqxmd.com/read/27595693/design-of-devote-trial-comparing-cardiovascular-safety-of-insulin-degludec-vs-insulin-glargine-in-patients-with-type-2-diabetes-at-high-risk-of-cardiovascular-events-devote-1
#17
Steven P Marso, Darren K McGuire, Bernard Zinman, Neil R Poulter, Scott S Emerson, Thomas R Pieber, Richard E Pratley, Poul-Martin Haahr, Martin Lange, Kirstine Brown Frandsen, Rasmus Rabøl, John B Buse
DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. The primary end point was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke...
September 2016: American Heart Journal
https://www.readbyqxmd.com/read/27593206/impact-of-the-mode-of-protraction-of-basal-insulin-therapies-on-their-pharmacokinetic-and-pharmacodynamic-properties-and-resulting-clinical-outcomes
#18
Tim Heise, Chantal Mathieu
Manufacturers of insulin products for diabetes therapy have long sought ways to modify the absorption rate of exogenously administered insulins in an effort to better reproduce the naturally occurring pharmacokinetics of endogenous insulin secretion. Several mechanisms of protraction have been used in pursuit of a basal insulin for which a low injection frequency would provide tolerable and reproducible glucose control; these mechanisms have met with varying degrees of success. Before the advent of recombinant DNA technology, development focused on modifications to the formulation that increased insulin self-association, such as supplementation with zinc or the development of pre-formed precipitates using protamine...
September 4, 2016: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27593174/efficacy-and-safety-of-thrice-weekly-insulin-degludec-in-elderly-patients-with-type-2-diabetes-assessed-by-continuous-glucose-monitoring
#19
Yoshio Nagai, Mariko Murakami, Kana Igarashi, Yuta Nakamura, Hidekazu Tsukiyama, Fumiaki Matsubara, Ami Nishine, Toshihiko Ohshige, Satoshi Ishii, Hiroyuki Kato, Yasushi Tanaka
As life expectancy becomes longer in Japan, there has been an increase of elderly patients with type 2 diabetes who need insulin therapy but cannot perform self-injection due to dementia or other conditions. Therefore, the aim of this study was to investigate the efficacy and safety of thrice-weekly insulin degludec therapy in elderly patients with poorly controlled diabetes. The subjects were 22 hospitalized elderly Japanese patients with type 2 diabetes who had difficulty with self-injection. After becoming stable on once-daily insulin degludec treatment, they were assigned to continue once-daily injection (OD group) or were switched to thrice-weekly injection (TW group) for one week...
September 2, 2016: Endocrine Journal
https://www.readbyqxmd.com/read/27589252/safety-and-efficacy-of-insulin-degludec-liraglutide-ideglira-added-to-sulphonylurea-alone-or-to-sulphonylurea-and-metformin-in-insulin-na%C3%A3-ve-people-with-type-2-diabetes-the-dual-iv-trial
#20
H W Rodbard, B W Bode, S B Harris, L Rose, L Lehmann, H Jarlov, J Thurman
AIM: To investigate the safety and efficacy of insulin degludec/liraglutide (IDegLira), a novel combination product, as add-on therapy for people with Type 2 diabetes uncontrolled on sulphonylurea therapy. METHODS: In this 26-week, double-blind trial, adults with Type 2 diabetes [HbA1c 53-75 mmol/mol (7.0-9.0%)] were randomized to IDegLira (n = 289) or placebo (n = 146) as add-on to pre-trial sulphonylurea ± metformin, titrating to a fasting glycaemic target of 4...
September 2, 2016: Diabetic Medicine: a Journal of the British Diabetic Association
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