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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
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
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
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...
October 6, 2016: Expert Opinion on Drug Metabolism & Toxicology
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
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
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
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
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...
August 6, 2016: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
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]
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
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
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
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
Yoshiko Onda, Rimei Nishimura, Kiyotaka Ando, Hiroshi Takahashi, Daisuke Tsujino, Kazunori Utsunomiya
AIMS: To compare glucose variability in patients with type 1 diabetes (T1D) treated with insulin glargine (IGla) versus insulin degludec (IDeg) using continuous glucose monitoring (CGM). METHODS: Thirteen patients with T1D were randomly assigned to receive IDeg once-daily followed by IGla twice-daily or vice versa. They were evaluated for glucose variability by CGM after >4weeks of treatment with either insulin, and then were crossed over to the other, and evaluated by CGM after >4weeks...
October 2016: Diabetes Research and Clinical Practice
Yukiko Onishi, Kenichi Yamada, Jeppe Zacho, Jan Ekelund, Yasuhiko Iwamoto
AIMS/INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit-to-unit from twice-daily basal or pre-mix insulin to twice-daily IDegAsp in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre-trial insulin...
August 25, 2016: Journal of Diabetes Investigation
Marc Evans, Jens Gundgaard, Brian Bekker Hansen
INTRODUCTION: To evaluate the cost-effectiveness of the co-formulation insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart (BIAsp 30), both administered twice daily, in patients with type 2 diabetes mellitus (T2DM), using a short-term cost-effectiveness model. METHODS: Data from two phase 3a treat-to-target clinical trials were used to populate a simple and transparent short-term cost-effectiveness model. The costs and effects of treatment with IDegAsp versus BIAsp 30 were calculated over a 5-year period, from a Danish health-care cost perspective...
August 23, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
K Stinkens, B Peene, C Mathieu
INTRODUCTION: The treatment of patients with type 2 diabetes mellitus remains challenging, as it goes beyond adequate glycemic control, in particular addressing weight, blood pressure and other contributors to cardiovascular disease. In addition, the progressive nature of type 2 diabetes mellitus demands the intensification and combination of glucose lowering therapies. In many patients, there is a clinical inertia for the initiation of insulin therapy, leading to failure in reaching glycemic targets in many patients...
September 2016: Expert Opinion on Biological Therapy
Elizabeth Mary Lamos, Stephen N Davis
INTRODUCTION: Type 2 diabetes is a complex disease requiring individualized and often multi-faceted treatment plans. Balancing glycemic control with adverse medication side effects can be challenging. Combination therapy of basal insulin and GLP-1 receptor agonist therapy appears to provide a balance between glycemic efficacy, hypoglycemia and weight gain. AREAS COVERED: Available pharmacokinetic data, clinical trials and abstracts regarding fixed-ratio combination of insulin degludec and liraglutide were reviewed...
October 2016: Expert Opinion on Drug Metabolism & Toxicology
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