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Arturo Rojas, Georgina Sposetti, Jorge L Gross, Douglas Eugenio Barbieri, Ran Duan, Bruno Linetzky, Janaina Martins De Lana, Oded Stempa, Angel Rodriguez
BACKGROUND: This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM). METHODS: A phase 4, randomized, open-label, parallel-arm trial included participants aged 18-75 years with T2DM taking once-daily insulin glargine and stable doses of metformin and/or pioglitazone with glycated hemoglobin (HbA1c) 7...
2016: Diabetology & Metabolic Syndrome
Linong Ji, Kyung Wan Min, Juliana Oliveira, Thomas Lew, Ran Duan
OBJECTIVE: The objective of this study was to explore the efficacy and safety of insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension [LM25]) or insulin glargine plus insulin lispro (G+L) in insulin-naïve patients with type 2 diabetes from different racial/ethnic groups. METHODS: Three subgroups from the PARADIGM study were analyzed post hoc: non-Asian (n=130), Asian Indian (n=106), and East Asian (n=89). RESULTS: All subgroups recorded glycated hemoglobin (HbA1c) reductions: non-Asian (LM25, -2...
2016: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
Stephen Lowe, Emanuele Sher, Graham Wishart, Kimberley Jackson, Eunice Yuen, Claire Brittain, Siew Chinn Fong, David O Clarke, William H Landschulz
Intranasally administered regular insulin and insulin aspart have shown cognitive benefit for patients with Alzheimer's disease (AD). To support development of intranasally administered insulin analogs for AD, the central disposition of intranasal insulin lispro in the cerebrospinal fluid (CSF) of healthy volunteers was investigated. Healthy volunteers (N = 8) received two sequential doses of intranasal insulin lispro (48 or 80 IU followed by 160 IU) by Aero Pump in an open-label, single-period study with serial CSF and serum sampling over 5 hours after each dose...
August 23, 2016: Drug Delivery and Translational Research
Christoph Hasslacher, Felix Kulozik, Justo Lorenzo Bermejo
OBJECTIVES: The influence of type of insulin treatment - insulin analogs versus human insulin - on the development of diabetes related vascular complications has been sparsely investigated. We examine here possible differences regarding kidney function and hemoglobin levels. METHODS: Multiple linear regression was used to investigate the relationship between the following characteristics measured in 509 type 1 diabetic patients who were recruited in an outpatient practice: current clinical status and treatment modalities, type of injected insulin and the routine laboratory parameters hemoglobin, HbA1c, serum creatinine, eGFR, hs CRP and urinary albumin/creatinine ratio...
August 2016: Therapeutic Advances in Endocrinology and Metabolism
Mary Pat Knadler, Tri-Hung Nguyen, Kristina Campanale, Michael J De Veer, John M Beals, Shun Li, Ryan Hansen, Angela Siesky, M Dodson Michael, Christopher J H Porter
PURPOSE: Determine the pharmacokinetics of insulin peglispro (BIL) in 5/6-nephrectomized rats and study the absorption in lymph duct cannulated (LDC) sheep. METHODS: BIL is insulin lispro modified with 20-kDa linear PEG at lysine B28 increasing the hydrodynamic size to 4-fold larger than insulin lispro. Pharmacokinetics of BIL and insulin lispro after IV administration were compared in 5/6-nephrectomized and sham rats. BIL was administered IV or SC into the interdigital space of the hind leg, and peripheral lymph and/or serum samples were collected from both LDC and non-LDC sheep to determine pharmacokinetics and absorption route of BIL...
August 15, 2016: Pharmaceutical Research
Vincent Lak, Ann-Marie Svensson, Mervete Miftaraj, Stefan Franzén, Björn Eliasson
INTRODUCTION: Studies comparing direct-acting insulin analogs (DAIs) in terms of effectiveness and long-term safety are scarce. Our aim was to explore these variables in clinical practice among patients with type 1 diabetes, including the elderly and those with renal impairment. METHODS: We linked four national registers in a population-based cohort study. Patients with type 1 diabetes and continuous use of all currently available DAIs (lispro, aspart, or glulisine) in 2005-2013 were monitored for up to 7...
September 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Susanne Famulla, Ulrike Hövelmann, Annelie Fischer, Hans-Veit Coester, Lidia Hermanski, Matthias Kaltheuner, Lars Kaltheuner, Lutz Heinemann, Tim Heise, Laurence Hirsch
OBJECTIVE: Lipohypertrophy (LHT) is common in insulin-treated patients but its exact impact on insulin absorption and action is unclear. RESEARCH DESIGN AND METHODS: In this crossover study, 13 patients with type 1 diabetes received subcutaneous abdominal injections of 0.15 units/kg insulin lispro into LHT (confirmed by examination and ultrasound) and normal adipose tissue (NAT). On one day, a euglycemic clamp was performed with two injections each into LHT and NAT, and on another day one injection per region was given before a standardized mixed meal (75 g carbohydrates), all in randomized order...
September 2016: Diabetes Care
(no author information available yet)
This article will be part of a supplement and will be republished when the entire issue is complete.
July 8, 2016: Diabetes, Obesity & Metabolism
Kevin Kaiserman, Heike Jung, Imane Benabbad, Beate Karges, Michel Polak, Myriam Rosilio
BACKGROUND: Insulin lispro, the first rapid-acting insulin analog, was developed 20 years ago and has been studied in multiple situations and various populations. OBJECTIVE: To review the literature on the use of insulin lispro in children, adolescents, and young adults. PATIENTS: Children, adolescents, and young adults with type-1-diabetes. METHODS: One hundred and twenty-two relevant publications, identified by a systematic (MEDLINE) and manual literature search, were reviewed...
July 8, 2016: Pediatric Diabetes
Qing Su, Chao Liu, Hongting Zheng, Jun Zhu, Peng Fei Li, Lei Qian, Wen Ying Yang
BACKGROUND: Premixed insulins are recommended starter insulins in Chinese patients after oral antihyperglycemic medication (OAM) failure. Here, we compared the efficacy and safety of Insulin Lispro Mix25 (LM25) twice daily (BID) and Insulin Lispro Mix50 (LM50) BID as starter insulin regimen in Chinese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with OAMs. METHODS: Primary efficacy outcome in this open-label, parallel, randomized clinical trial was change in hemoglobin A1c (HbA1c) from baseline to 26 weeks...
July 1, 2016: Journal of Diabetes
J Gordon, P McEwan, U Sabale, B Kartman, B H R Wolffenbuttel
OBJECTIVE: To evaluate the cost-effectiveness of exenatide twice daily (BID) versus bolus insulin lispro three times daily (TID) as add-on therapy when glycemic control is suboptimal with titrated basal insulin glargine and metformin. METHODS: The analysis was based on the recent 4B Study, which compared exenatide BID and lispro TID as add-on therapies in subjects with type 2 diabetes insufficiently controlled despite titrated insulin glargine. The Cardiff Diabetes Model was used to simulate patient costs and health benefits beyond the 4B Study...
June 29, 2016: Journal of Medical Economics
Roberto Visentin, Clemens Giegerich, Robert Jäger, Raphael Dahmen, Anders Boss, Marshall Grant, Chiara Dalla Man, Claudio Cobelli, Thomas Klabunde
BACKGROUND: Technosphere(®) insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose. We used the University of Virginia (UVA)/Padova simulator to explore in-silico the potential benefit of different dosing regimens on postprandial glucose (PPG) control to support the design of further clinical trials. Tested dosing regimens included at-meal or postmeal dosing, or dosing before and after a meal (split dosing). METHODS: Various dosing regimens of TI were compared among one another and to insulin lispro in 100 virtual type-1 patients...
September 2016: Diabetes Technology & Therapeutics
Johan Jendle, Marcia A Testa, Sherry Martin, Honghua Jiang, Zvonko Milicevic
AIM: To conduct a substudy, using 24-hour continuous glucose monitoring (CGM), of the AWARD-4 trial, which was designed to compare insulin + glucagon-like peptide-1 receptor agonist treatment with an insulin-only regimen. METHODS: The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring...
October 2016: Diabetes, Obesity & Metabolism
Jinbo Hu, Hui Shi, Changhong Zhao, Xiyue Li, Yue Wang, Qingfeng Cheng, Richa Goswami, Qianna Zhen, Mei Mei, Ying Song, Shumin Yang, Qifu Li
OBJECTIVE: The aim of this study is to evaluate the pharmacokinetic and pharmacodynamic (PK-PD) profiles of lispro administered by the QS-M needle-free jet injector in Chinese subjects. RESEARCH DESIGN AND METHODS: A randomized, double-blind, double-dummy, cross-over study was performed. Eighteen healthy volunteers were recruited. Lispro (0.2 units/kg) was administered by the QS-M needle-free jet injector or by conventional pen. Seven-hour euglycemic clamp tests were performed...
September 2016: Expert Opinion on Drug Delivery
Richard M Bergenstal, Helen Lunt, Edward Franek, Florence Travert, Jiani Mou, Yongming Qu, Caryl J Antalis, Mark L Hartman, Myriam Rosilio, Scott J Jacober, Edward J Bastyr
AIMS: To compare the efficacy and safety of basal insulin peglispro (BIL), with a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes. MATERIALS AND METHODS: In this Phase 3, 52-week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3:2 distribution to receive either BIL (N = 664) or GL (N = 450) at bedtime, with preprandial insulin lispro, using intensive insulin management...
June 6, 2016: Diabetes, Obesity & Metabolism
Thomas Blevins, Thomas R Pieber, Gildred Colón Vega, Shuyu Zhang, Edward J Bastyr Iii, Annette M Chang
AIMS: To evaluate the efficacy and safety of basal insulin peglispro (BIL) vs insulin glargine, in combination with prandial insulin lispro, in type 2 diabetes (T2D) patients. MATERIALS AND METHODS: This Phase 3, multicenter, double-blind, 26-week study randomized T2D patients (HbA1c ≥7% and <12%, on ≥1 insulin injections daily) to BIL (N = 691) or glargine (N = 678), in combination with lispro. RESULTS: At Week 26, the primary objective of noninferiority of BIL vs glargine for HbA1c reduction was achieved (least squares mean difference -0...
May 28, 2016: Diabetes, Obesity & Metabolism
Cortney M Mospan
Two concentrated analog insulins, long-acting insulin glargine U-300 (Toujeo) and rapid-acting insulin lispro (Humalog U-200), were recently approved by the FDA. Providers must be aware of clinical differences in these new product formulations compared with their nonconcentrated formulations, so that they can select appropriate patients for these products and minimize drug errors.
June 2016: JAAPA: Official Journal of the American Academy of Physician Assistants
Olga Valerianovna Selivanova, Mariya Yu Suvorina, Alexey K Surin, Nikita V Dovidchenko, Oxana Galzitskaya
There are different insulin analogues with various pharmacokinetic characteristics, such as, rapid-acting, long-acting, or intermediate-acting analogues. Since insulin tends to form amyloid aggregates, it is of particular interest to measure characteristic times of formation of amyloid aggregates and compare those to action times for insulin and its analogues. For the study we have chosen one of the insulin analogues - insulin Lispro, which is a fast acting insulin analog. It is usually thought of amyloid aggregation as a nucleation-dependent process...
May 26, 2016: Current Protein & Peptide Science
Angela M Thompson, Jennifer M Trujillo
The purpose of this review is to provide a review of current data of the most recently approved glucagon-like peptide (GLP)-1-receptor agonist, dulaglutide, in the treatment of type 2 diabetes. To complete this, a PubMed search was performed to identify manuscripts published from 1947 to July 2015. The search terms "Trulicity", "dulaglutide", and "LY2189265" were utilized, and publications were included if they evaluated the pharmacology, pharmacokinetics, efficacy, safety, or patient-reported outcomes of dulaglutide...
2016: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
Ajay Kumar
Type 2 diabetes (T2D) represents an escalating burden worldwide, particularly in China and India. Compared with Caucasians, Asian people with diabetes have lower body mass index, increased visceral adiposity, and postprandial glucose (PPG)/insulin resistance. Since postprandial hyperglycemia contributes significantly to total glycemic burden and is associated with heightened cardiovascular risk, targeting PPG early in T2D is paramount. Premixed insulin regimens are widely used in Asia due to their convenience and effectiveness...
May 2016: Indian Journal of Endocrinology and Metabolism
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