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Katie L Anderson, Hilaree N Frazier, Shaniya Maimaiti, Vikas V Bakshi, Zana R Majeed, Lawrence D Brewer, Nada M Porter, Ai-Ling Lin, Olivier Thibault
Novel therapies have turned to delivering compounds to the brain using nasal sprays, bypassing the blood brain barrier, and enriching treatment options for brain aging and/or Alzheimer's disease. We conducted a series of in vivo experiments to test the impact of intranasal Apidra, a zinc-free insulin formulation, on the brain of young and aged F344 rats. Both single acute and repeated daily doses were compared to test the hypothesis that insulin could improve memory recall in aged memory-deficient animals. We quantified insulin signaling in different brain regions and at different times following delivery...
April 10, 2016: Journals of Gerontology. Series A, Biological Sciences and Medical Sciences
S Franzè, F Cilurzo, P Minghetti
The impending expiration of patent protection for recombinant insulins provides the opportunity to introduce cost-saving copies, named biosimilars, onto the market. Although there is broad experience in the production and characterisation of insulins, the development of copies is still a challenge. In this paper, the main features of insulins and the EU regulatory framework for their biosimilar products are reviewed. The main focus is on rapid-acting insulin analogues (Humalog(®); Novolog(®)/NovoRapid(®); Apidra(®))...
April 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
M Konstantinova, V Loizeau, V Pilorget, A Cali, T Danne
OBJECTIVE: Data on the safety of insulin glulisine for type 1 diabetes are limited in paediatric populations. The European post-marketing Observational prospective Cohort study of children with type 1 diabetes treated with APIDRA(®) (OCAPI) study evaluated the safety of insulin glulisine in children aged 6-12 years in real-life clinical practice, with a particular focus on the 6-8 years age group. RESEARCH DESIGN AND METHODS: OCAPI was an international, multicentre, observational, non-interventional, prospective cohort study, in which 94 participants with type 1 diabetes (6-8 years age group: n=31; 9-12 years age group: n=63) received insulin glulisine for 6 months under normal, local conditions...
October 2014: Experimental and Clinical Endocrinology & Diabetes
Peter Vestergaard, Jakob Starup-Linde
AIM: To conduct a systematic review of the published pre-clinical in vitro and in vivo evidence for plausible mechanisms underlying the risk of cancer associated with insulin and insulin analogues. MATERIAL AND METHODS: The review was developed according to the PRISMA guidelines. A systematic search of Pubmed was performed using the key words: "insulin analogue", "insulin derative", "insulin homologue", "glargine", "Lantus", "degludec", "tresiba", "NPH", "lispro", "humalog", "detemir", "levemir", "glulisine", "apidra", "aspart", "novolog", "insulin treatment", "diabetes treatment", "insulin therapy" or "diabetes therapy" combined with "neoplasia", "tumor", "cancer", "carcinoma", "malignan*", "carcinog*" or " mitoge*"...
November 2013: Current Drug Safety
Stewart B Harris, Jean-François Yale, Lori Berard, John Stewart, Babak Abbaszadeh, Susan Webster-Bogaert, Hertzel C Gerstein
OBJECTIVE Diabetes self-management is universally regarded as a foundation of diabetes care. We determined whether comparable glycemic control could be achieved by self-titration versus physician titration of a once-daily bolus insulin dose in patients with type 2 diabetes who are unable to achieve optimal glycemia control with a basal insulin. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes, an HbA1c level >7% (53 mmol/mol), and either nocturnal hypoglycemia episodes or an insufficient basal insulin glargine level (with or without oral agents) to achieve a fasting plasma glucose level ≤6 mmol/L (108 mg/dL) were studied...
2014: Diabetes Care
Ayse Pinar Cemeroglu, Lora Kleis, Andrew Wood, Chad Parkes, Michael A Wood, Alan T Davis
OBJECTIVE: Rapid-acting insulins, including insulin aspart (NovoLog) and lispro (Humalog), do not seem to effectively control postprandial glycemic excursions in children with type 1 diabetes mellitus (T1DM). The objective of this study was to determine if insulin glulisine (Apidra), another rapid-acting insulin analog, would be superior in controlling postprandial hyperglycemia in children with T1DM. METHODS: Thirteen prepubertal children ages 4 to 11 years completed this study...
July 2013: Endocrine Practice
Cornelius Hess, Andreas Thomas, Mario Thevis, Bernd Stratmann, Wulf Quester, Diethelm Tschoepe, Burkhard Madea, Frank Musshoff
Possible fatal complications of human insulin and its synthetic analogues like hypoglycemia require precise classification and quantitative determination of these drugs both for clinical purposes as well as for forensic toxicologists. A procedure was developed for the identification and quantification of human insulin and different long-acting as well as short-acting synthetic insulins in human blood serum specimens. After an immunoaffinity purification step and separation by liquid chromatography, the insulins were characterized by their five- or sixfold protonated molecule ions and diagnostic product ions...
October 2012: Analytical and Bioanalytical Chemistry
Andreas Thomas, Wilhelm Schänzer, Philippe Delahaut, Mario Thevis
For most peptide hormones prohibited in elite sports the concentrations in plasma or urine are very low (pg/mL). Accordingly, hyphenated purification and enrichment steps prior to mass spectrometric detection are required to obtain sufficient doping control assays. Immunoaffinity purification in combination with nano-scale liquid chromatography coupled to high resolution/high accuracy mass spectrometry was found to have the potential of providing the necessary sensitivity and unambiguous specificity to produce reliable results...
February 2012: Methods: a Companion to Methods in Enzymology
Haim Werner, Ernst A Chantelau
In order to provide comprehensive information on the differences in bioactivity between human insulin and insulin analogues, published in vitro comparisons of human insulin and the rapid acting analogues insulin lispro (Humalog®), insulin aspart ( NovoRapid®), insulin glulisine (Apidra®), and the slow acting analogues insulin glargine (Lantus®), and insulin detemir (Levemir®) were gathered from the past 20 years (except for receptor binding studies). A total of 50 reports were retrieved, with great heterogeneity among study methodology...
2011: Diabetology & Metabolic Syndrome
Anna Lih, Emily Hibbert, Tang Wong, Christian M Girgis, Nidhi Garg, John N Carter
Glulisine (Apidra(®)) is a rapid-acting human insulin analog approved for use in children with diabetes mellitus ≥4 years of age. Management of children with type 1 diabetes has seen a shift in favor of mimicking normal physiological insulin responses with multiple daily injections or continuous subcutaneous insulin infusions (CSII). Few studies have compared the rapid-acting insulin analogs in this population but limited data indicate that glulisine is as effective as lispro when used in a basal-bolus regimen...
2010: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
J Joya-Galeana, M Fernandez, A Cervera, S Reyna, S Ghosh, C Triplitt, N Musi, R A DeFronzo, E Cersosimo
BACKGROUND: To test potential differences between the actions of anti-diabetic medications, we examined the effects of oral hypoglycaemic agents versus glargine-apidra insulin therapy in T2DM. METHODS: T2DM subjects were randomized to either oral hypoglycaemic agents (pioglitazone, metformin and glipizide, n = 9) or insulin therapy (n = 12) for 6 months. Carotid intimal media thickness, vascular reactivity (flow-mediated vasodilatation; percent change in brachial artery basal diameter post-ischaemia) and sublingual nitrate were measured with ultrasonography...
May 2011: Diabetes/metabolism Research and Reviews
Karly P Garnock-Jones, Greg L Plosker
Insulin glulisine (Apidra) is a human insulin analogue approved for the improvement of glycaemic control in adults, adolescents and children with diabetes mellitus. It has similar binding properties, and is associated with a faster onset but similar level of glucose disposal, to regular human insulin (RHI). Insulin glulisine and insulin lispro have similar effects on glucose levels. Insulin glulisine is effective when compared to other short- and rapid-acting insulins, demonstrating either noninferiority, no significant difference, or superiority in primary endpoints in studies involving patients with type 1 and type 2 diabetes...
May 29, 2009: Drugs
Ashish Shukla, Harald Enzmann, Doris Mayer
The structural modification of insulin results in the generation of insulin analogues that show altered binding affinities to the insulin receptor and/or the IGF-I receptor, and as a consequence insulin analogues may have altered mitogenic potency. We analysed the proliferative effect of the rapid-acting insulin analogue Apidra (insulin glulisine) on mammary epithelial cells. We show that Apidra and Actrapid (recombinant human insulin) have similar proliferative effects on benign MCF10A and tumorigenic MCF7 cells and on epithelial cells of mouse mammary gland...
July 2009: Archives of Physiology and Biochemistry
M R Lankisch, K C Ferlinz, J L Leahy, W A Scherbaum et al.
AIM: To investigate whether the addition of a single bolus of insulin glulisine (glulisine), administered at either breakfast or main mealtime, in combination with basal insulin glargine (glargine) and oral antidiabetic drugs (OADs), provides equivalent glycaemic control in patients with type 2 diabetes, irrespective of the time of glulisine injection. METHODS: A national, multicentre, randomized, open-label, parallel-group study of 393 patients with type 2 diabetes who were suboptimally controlled [haemoglobin A(1c) (HbA(1c)) > 6...
December 2008: Diabetes, Obesity & Metabolism
Norbert Hermanns, Bernhard Kulzer, Thomas Haak
BACKGROUND: Pen devices can help to overcome some of the barriers associated with insulin therapy. The present study evaluated the accuracy of dose delivery by people with diabetes using the novel prefilled, disposable SoloSTAR device with insulin glargine (Lantus) and insulin glulisine (Apidra) (all from sanofi-aventis, Paris, France). METHODS: People with type 1 or type 2 diabetes (insulin users or insulin naive) were eligible to participate in this randomized, single-center, open-label study...
August 2008: Diabetes Technology & Therapeutics
Heather Ulrich, Benjamin Snyder, Satish K Garg
Normalization of blood glucose is essential for the prevention of diabetes mellitus (DM)-related microvascular and macrovascular complications. Despite substantial literature to support the benefits of glucose lowering and clear treatment targets, glycemic control remains suboptimal for most people with DM in the United States. Pharmacokinetic limitations of conventional insulins have been a barrier to achieving treatment targets secondary to adverse effects such as hypoglycemia and weight gain. Recombinant DNA technology has allowed modification of the insulin molecule to produce insulin analogues that overcome these pharmacokinetic limitations...
2007: Vascular Health and Risk Management
Alastair Clarke, Geralyn Spollett
SoloStar (sanofi-aventis) is a new, disposable insulin pen for the administration of insulin glargine (Lantus, sanofi-aventis) or insulin glulisine (Apidra, sanofi-aventis). SoloStar was developed to address a wide range of patient needs and demonstrates advancement over previous devices, owing to its appropriate combination of ergonomically-tested and mechanically improved features. The authors report the results of key investigations carried out by sanofi-aventis as part of the SoloStar development plan, including dose accuracy and injection force testing...
March 2007: Expert Opinion on Drug Delivery
Christian Poulsen, Lotte Langkjaer, Carsten Worsøe
BACKGROUND: The commercially available insulin products insulin aspart injection (IAsp) and insulin glulisine injection (IGlu), used for continuous subcutaneous insulin infusion (CSII), have been compared with respect to resistance towards isoelectric insulin precipitation. Additionally, a hybrid product consisting of the insulin aspart analogue in an IGlu product composition (the hybrid product was termed IAsp (Apidra)) has been examined. METHODS: The degree of isoelectric insulin precipitation was examined by reverse-phase high performance liquid chromatography while reducing pH through addition of diluted HCl...
February 2007: Diabetes Technology & Therapeutics
(no author information available yet)
The third one so far. Does it offer any advantage over the other two?
April 24, 2006: Medical Letter on Drugs and Therapeutics
Mario Thevis, Andreas Thomas, Philippe Delahaut, Alain Bosseloir, Wilhelm Schänzer
Insulin and related synthetic therapeutics have been prohibited by the World Anti-Doping Agency for athletes demonstrably not suffering from diabetes mellitus. The primary specimen for doping controls has been urine, but the renal excretion of intact human insulin as well as synthetic analogues such as the rapid-acting products Humalog LisPro, Novolog Aspart, and Apidra Glulisine has been reported negligible owing to metabolic degradation. Nevertheless, employing solid-phase extraction in combination with immunoaffinity purification followed by a top-down sequencing-based mass spectrometric approach, an assay was established allowing the identification of three intact rapid-acting synthetic insulins in doping control urine samples...
March 15, 2006: Analytical Chemistry
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