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Soichi Takeishi, Hiroki Tsuboi, Shodo Takegoshi
AIMS/INTRODUCTION: We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/ml (G+G300) to that of insulin lispro + insulin glargine biosimilar (L+GB). MATERIALS AND METHODS: 30 patients with type 2 diabetes who wear continuous glucose monitoring device in admission after glucose levels were stabilized by morning long-acting and ultra-rapid-acting insulins were randomly allocated to groups who received G+G300 on days 1 and 2 and the same dose L+GB on days 3 and 4, or vice versa...
March 28, 2017: Journal of Diabetes Investigation
Jürgen Harreiter, Lana Kosi-Trebotic, Albert Lukas, Peter Wolf, Yvonne Winhofer, Anton Luger, Alexandra Kautzky-Willer, Michael R Krebs
INTRODUCTION: To prove the feasibility and safety of a conversion to once-daily injected GLP1 agonist (lixisenatide) and long-acting basal insulin analogue (glargine) in patients with T2DM and poorly controlled glycemia previously treated with multiple injections of premixed insulins (iPremix) in an outpatient setting. METHODS: Nine patients with T2DM currently receiving iPremix formulations and poor glycemic control were switched to once-daily injected lixisenatide (Lixi) and basal insulin analogue glargine (iGlar) for a 12-week period...
March 29, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
R Gómez-Huelgas, J Sabán-Ruiz, F J García-Román, N Quintela-Fernández, J M Seguí-Ripoll, M V Bonilla-Hernández, G Romero-Meliá
OBJECTIVES: To assess the safety and efficacy of a basal-plus (BP) regimen with insulin glargine (as basal insulin) and insulin glulisine (as prandial insulin) with the main meal for elderly patients with type 2 diabetes mellitus (DM2) and high cardiovascular risk, following standard clinical practice. PATIENTS AND METHODS: An observational, retrospective study was conducted in 21 centres of internal medicine in Spain. The study included patients aged 65 years or older with DM2, undergoing treatment with a BP regimen for 4 to 12 months before inclusion in the study and a diagnosis of cardiovascular disease or high cardiovascular risk...
March 14, 2017: Revista Clínica Española
Marion Afonso, Fay Ryan, Ashley Pitcher, Elisheva Lew
OBJECTIVES: This study investigated the cost per responder and number needed to treat (NNT) in type 2 diabetes mellitus (T2DM) patients for lixisenatide compared to insulin intensification regimens using composite endpoints in the UK, Italy, and Spain. METHODS: Efficacy and safety outcomes were obtained from GetGoal Duo-2, a 26-week phase 3 trial comparing lixisenatide versus insulin glulisine (IG) once daily (QD) and three times daily (TID). Response at week 26 was extrapolated to 52 weeks assuming a maintained treatment effect, based on long-term evidence in other T2DM populations...
March 8, 2017: Journal of Medical Economics
Delilah McCarty, Megan Coleman, Cassie L Boland
OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the glucagon-like peptide-1 receptor agonist (GLP-1RA), lixisenatide, in the treatment of type 2 diabetes mellitus. DATA SOURCES: A PubMed (1966-2016) search was conducted using the following keywords: lixisenatide, AVE0010, glucagon-like peptide-1 agonist, and type 2 diabetes. References were reviewed to identify additional sources. STUDY SELECTION AND DATA EXTRACTION: Articles written in English were included if they evaluated the pharmacology, pharmacokinetics, efficacy, or safety of lixisenatide in human subjects...
May 2017: Annals of Pharmacotherapy
Jorge Enrique Machado-Alba, Diego Alejandro Medina-Morales
AIMS: To compare the effect on metabolic control of treatment with conventional and analogue insulins for patients with diabetes mellitus. METHODS: Retrospective cohort study held in cities of Colombia (Pereira and Manizales). People insured by the paid healthcare system, who were diagnosed with diabetes mellitus type 1 and 2, and treated with conventional and analogue insulin for at least 6 months prior to the start of the study were sampled and followed up for 18 months...
December 2016: International Journal of Clinical Practice
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
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...
March 2017: Pediatric Diabetes
Julio Rosenstock, Bruno Guerci, Markolf Hanefeld, Sandro Gentile, Ronnie Aronson, Francisco J Tinahones, Christine Roy-Duval, Elisabeth Souhami, Marek Wardecki, Jenny Ye, Riccardo Perfetti, Simon Heller
OBJECTIVE: To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs). RESEARCH DESIGN AND METHODS: Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization...
August 2016: Diabetes Care
João Leopoldo Oliveira Araujo, Mariana Donato Pereira, Cristiane de Cássia Bergamaschi, Fernando de Sá Del Fiol, Luciane Cruz Lopes, Maria Inês de Toledo, Silvio Barberato-Filho
BACKGROUND: In 2011, private pharmacies associated to the Brazilian Ministry of Health provided patients with two types of insulin (regular human insulin and isophane insulin or NPH) and three oral antidiabetic medications (5 mg glibenclamide and 500 and 850 mg metformin) free of charge. The aim was to evaluate the impact of the "Health Has No Price" Program [Saúde Não Tem Preço (SNTP)] for access to diabetes treatment medicines in Brazil. METHODS: This longitudinal and observational study is based on the number of units of oral hypoglycemic agents, insulin and insulin analogues supplied in 55,000 private pharmacies from February 1, 2010 to January 31, 2012...
2016: Diabetology & Metabolic Syndrome
Kaisa Miikkulainen, Antonio Caruso, Oliver Mast, Rongrong Zhang, Oleg Borisenko
BACKGROUND: Safe and effective insulin therapy for diabetes mellitus requires initial dose titration and regular adjustments based on blood glucose (BG) monitoring. Our objective was to explore the use of BG measurement in phase-III clinical studies of insulin analogs. These studies provide safety and efficacy information for regulatory authorities and are the basis for insulin analog regulatory approval. METHODS: A systematic review of phase-III studies of rapid-acting insulin analogs (insulin lispro, insulin aspart and insulin glulisine) and pre-mixed insulin analogs (biphasic insulin aspart and insulin lispro mix) was conducted...
May 4, 2016: BMC Endocrine Disorders
Yoel Toledano, Eran Hadar, Moshe Hod
INTRODUCTION: Diabetes during pregnancy may lead to maternal, fetal and neonatal complications. In order to limit unwarranted outcomes, strict glycemic control is essential. In the past, human insulin was the only insulin formulation administered in pregnancy. However, insulin analogues have also been used for this indication in recent years. AREAS COVERED: This article reviews the published data regarding the safety of insulin analogue use during pregnancy. We present the qualities, advantages and pitfalls of insulin analogue use in pregnancy compared with human insulin...
July 2016: Expert Opinion on Drug Safety
Ariel Zisman, Francienid Morales, John Stewart, Andreas Stuhr, Aleksandra Vlajnic, Rong Zhou
INTRODUCTION: In patients with type 2 diabetes mellitus (T2DM) with uncontrolled glycemia despite ongoing upward titration of basal insulin, targeting postprandial hyperglycemia may be required. Nevertheless, the point at which basal insulin is fully optimized and postprandial glucose (PPG) should be targeted with additional treatment remains unclear. We report here on the BeAM value (difference between bedtime and morning blood glucose values) as an indicator of the need to target PPG...
2016: BMJ Open Diabetes Research & Care
Carlos Culquichicón-Sánchez, Ricardo Correa, Igor Flores-Guevara, Frank Espinoza Morales, Christian R Mejia
We present the 15th case reported worldwide and 3rd case reported in Latin America of immune thrombocytopenic purpura associated with Type 1 diabetes mellitus in Scopus, MEDLINE, and SciELO. An 11-year-old male patient of mixed ethnicity with immune thrombocytopenic purpura, Type 1 diabetes mellitus, and gastritis due to H. pylori presented to the emergency room with petechiae, ecchymosis, and gingival and conjunctival bleeding that had been worsening for the past three months. The patient had a body mass index of 18...
2016: Curēus
N V Efremova, L L Bolotskaya, D S Atarshchikov, O N Bondarenko, A V Il'in, M V Shestakova
AIM: To implement in 2009-2012 the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen in patients with type 1 diabetes mellitus (DM) to evaluate the efficiency and safety of therapy with human insulin analogues. MATERIAL AND METHODS: The program covered 100 patients aged 19 to 25 years from 7 regions of the Russian Federation, who had had DM onset at the age of 9-13 years, were using human recombinant insulins as continuous insulin therapy, and had glycated hemoglobin (HbA1c) levels of 7 to 9%...
2015: Terapevticheskiĭ Arkhiv
Chen Zhou, Wei Qi, E Neil Lewis, John F Carpenter
To generate aggregates, 3 insulin analogs, lispro, aspart, and glulisine, were incubated without phenolic preservatives for 30 days at 37 °C. As a function of incubation time, aggregation was quantified with size exclusion chromatography, and the sizes of aggregates and the conformations of the constituent molecules were characterized with concomitant dynamic light scattering and Raman spectroscopy. During incubation, lispro was progressively converted into soluble aggregates with hydrodynamic diameters of circa 15 nm, and 95% of the native protein had aggregated at day 30...
February 2016: Journal of Pharmaceutical Sciences
Kahori Watanabe, Yoshiki Kusunoki, Tomoyuki Katsuno, Rie Nakae, Toshihiro Matsuo, Fumihiro Ochi, Masaru Tokuda, Takafumi Akagami, Masayuki Miuchi, Jun-Ichiro Miyagawa, Mitsuyoshi Namba
No abstract text is available yet for this article.
October 2016: Acta Diabetologica
F Porcellati, P Lucidi, G B Bolli, C G Fanelli
The add-on of a prandial (short-acting) GLP-1 RA to basal insulin in subjects with T2DM who fail to control A1C on basal insulin, stems from the physiological principles of post-prandial glucose homeostasis, and it is based on evidence from clinical trials. The 4B and GetGoal DUO 2 studies are the first to establish in head-to-head comparison, the efficacy and safety of short-acting GLP-1 RAs vs prandial insulin, when added-on to basal insulin glargine. In the 4B study (exenatide 2/d vs lispro 3/d) exenatide demonstrated similar efficacy vs lispro in reducing A1C to ~7...
December 2015: Diabetes & Metabolism
Martin Pfohl, Thorsten Siegmund, Stefan Pscherer, Katrin Pegelow, Jochen Seufert
BACKGROUND: Due to the progressive nature of type 2 diabetes mellitus (T2DM), antidiabetic treatment needs to be continuously intensified to avoid long-term complications. In T2DM patients on either basal insulin-supported oral therapy (BOT) or supplementary insulin therapy (SIT) presenting with HbA1c values above individual targets for 3-6 months, therapy should be intensified. This study investigated effectiveness and tolerability of an intensification of BOT or SIT to a basal-bolus therapy (BBT) regimen in T2DM patients in daily clinical practice...
2015: Vascular Health and Risk Management
Stephen Atkin, Zeeshan Javed, Gregory Fulcher
Patients with type 2 diabetes mellitus require insulin as disease progresses to attain or maintain glycaemic targets. Basal insulin is commonly prescribed initially, alone or with one or more rapid-acting prandial insulin doses, to limit mealtime glucose excursions (a basal-bolus regimen). Both patients and physicians must balance the advantages of improved glycaemic control with the risk of hypoglycaemia and increasing regimen complexity. The rapid-acting insulin analogues (insulin aspart, insulin lispro and insulin glulisine) all have similar pharmacokinetic and pharmacodynamic characteristics and clinical efficacy/safety profiles...
November 2015: Therapeutic Advances in Chronic Disease
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