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Tina Sartorius, Anita M Hennige, Andreas Fritsche, Hans-Ulrich Häring
AIMS: Recent studies have identified unique brain effects of insulin detemir (Levemir®). Due to its pharmacologic properties, insulin detemir may reach higher concentrations in the brain than regular insulin. This might explain the observed increased brain stimulation after acute insulin detemir application but it remained unclear whether chronic insulin detemir treatment causes alterations in brain activity as a consequence of overstimulation. METHODS: In mice, we examined insulin detemir's prolonged brain exposure by continuous subcutaneous (s...
2016: PloS One
D Orozco-Beltran, C Pan, A L Svendsen, L Faerch, S Caputo
OBJECTIVE: To investigate the effect of healthcare provider (HCP) type (primary vs. specialist) on glycaemic control and other treatment parameters. RESEARCH DESIGN AND METHODS: Study of Once-Daily Levemir (SOLVE(™) ) is an international, 24-week, observational study of insulin initiation in people with type 2 diabetes. RESULTS: A total of 17,374 subjects were included, comprising 4144 (23.9%) primary care subjects. Glycaemic control improved in both HCP groups from baseline to final visit [glycated haemoglobin (HbA1c) -1...
March 2016: International Journal of Clinical Practice
N Shehadeh, Y Maor
We performed a non-inferiority trial comparing insulin detemir (Levemir) and biphasic insulin (NovoMix70) to standard care during Ramadan fast in insulin treated type 2 diabetes mellitus (T2DM) patients. This was an open label, controlled, multicentre, cluster randomised non-inferiority study. Insulin treated T2DM patients from 12 randomly selected primary clinics received Levemir and NovoMix 70 (intervention, n = 127) or standard care according to the American Diabetes Association recommendations (control, n = 118)...
November 2015: International Journal of Clinical Practice
Shaniya Maimaiti, Katie L Anderson, Chris DeMoll, Lawrence D Brewer, Benjamin A Rauh, John C Gant, Eric M Blalock, Nada M Porter, Olivier Thibault
Peripheral insulin resistance is a key component of metabolic syndrome associated with obesity, dyslipidemia, hypertension, and type 2 diabetes. While the impact of insulin resistance is well recognized in the periphery, it is also becoming apparent in the brain. Recent studies suggest that insulin resistance may be a factor in brain aging and Alzheimer's disease (AD) whereby intranasal insulin therapy, which delivers insulin to the brain, improves cognition and memory in AD patients. Here, we tested a clinically relevant delivery method to determine the impact of two forms of insulin, short-acting insulin lispro (Humalog) or long-acting insulin detemir (Levemir), on cognitive functions in aged F344 rats...
January 2016: Journals of Gerontology. Series A, Biological Sciences and Medical Sciences
Yang Xu, Marita Prohn, Xiaoyan Cai, Michael Crutchlow, Sudha S Shankar, Kevin Bateman, Eric J Woolf
BACKGROUND: A direct comparison of radioimmunoassay (RIA) and LC-MS/MS for insulin glargine quantification in human plasma is provided. RESULTS: Compared with the RIA, the LC-MS/MS assay exhibited comparable/improved sensitivity (LLOQ at 0.1 ng/ml [˜16.7 pM or 2.8 μU/ml] for glargine and its metabolites M1 and M2, respectively) and ruggedness. Most importantly, it demonstrated a superior specificity advantage against the interference from endogenous insulin, exogenous insulin analogs (e...
2014: Bioanalysis
Xiaoyan Zhu, Jingjing Liu, Jie Wu, Rongyue Cao, Taiming Li
HS061, a new structure analogue of human insulin, was investigated for the treatment of diabetes. In this study, we developed a simple and accurate UPLC-MS/MS method for the pharmacokinetic studies of HS061 in non-diabetic rats followed by a full method validation. Following a simple protein precipitation with acetonitrile, the analyte and internal standard (Levemir, IS) were separated on a Waters XBridge™ BEH300 C4 column (100 mm × 4.6 mm i.d., 3.5 μm) with a gradient elution using acetonitrile and 0.2% aqueous formic acid...
September 15, 2014: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Riccardo Torosantucci, Vera Brinks, Grzegorz Kijanka, Liem Andhyk Halim, Melody Sauerborn, Huub Schellekens, Wim Jiskoot
Mouse models are commonly used to assess the immunogenicity of therapeutic proteins and to investigate the immunological processes leading to antidrug antibodies. The aim of this work was to develop a transgenic (TG) Balb/c mouse model for evaluating the immunogenicity of recombinant human insulin (insulin) formulations. Validation of the model was performed by measuring the antibody response against plain and particulate insulin in TG and nontransgenic (NTG) mice. Intraperitoneal administration of insulin (20 μg/dose, 12 doses over a period of 4 weeks) did not break the immune tolerance of the TG mice, whereas it did elicit antibodies in NTG mice...
May 2014: Journal of Pharmaceutical Sciences
Jean-François Yale, Taner Damci, Marcel Kaiser, Eddy Karnieli, Kamlesh Khunti, Andreas Liebl, Florian Mm Baeres, Anne Louise Svendsen, Stuart A Ross
BACKGROUND: Obesity is common in type 2 diabetes (T2DM) and is associated with increased risk of morbidity and all-cause mortality. This analysis describes weight changes associated with insulin detemir initiation in real-life clinical practice. METHODS: Study of Once-Daily Levemir (SOLVE) was a 24-week international observational study of once-daily insulin detemir as add-on therapy in patients with T2DM receiving oral hypoglycaemic agents (OHAs). RESULTS: 17,374 participants were included in the analysis: mean age 62 ± 12 years; weight 80...
2013: Diabetology & Metabolic Syndrome
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
Ayesha Sethi, Muhammad Sher, Muhammad Rouf Akram, Sabiha Karim, Sonia Khiljee, Ashif Sajjad, Syed Nisar Hussain Shah, Ghulam Murtaza
Albumin is one of the most extensively studied endogenous proteins which are used in the fabrication of drug delivery and diagnostic technologies during last 10 years. This review provides a summary of products involving the use of albumin as a drug delivery tool for getting better the pharmacokinetics of a drug by developing the targetted drug delivery systems and diagnosing the pathologies. Using albumin, following market approved products have been developed: Levemir and Victoza (antidiabetic product), Abraxane (antimetastatic breast cancer product), and Nanocoll and Albures (for lymphoscintigraphy and diagnosis of cancer and rheumatoid arthritis)...
July 2013: Acta Poloniae Pharmaceutica
Chang-yu Pan, Li-nong Ji, Ju-ming Lu, Wen-ying Yang, Zhi-guang Zhou, Da-jin Zou, Qiu-he Ji, Ping Han, Jie Liu, Qiang Li, Ben-li Su, Yan-bing Li, Zheng-nan Gao, Peng-hua Wang, Shi-nan Yin, Yan-hu Dong, Tao Yang, Kan Sun, Hong Li, Xu Hong, Jing Lin, Jing-mei Shi, Xiao-jie Yang, Hui Fang, Xiao-dong Yan
OBJECTIVE: Study of Once-daily LeVEmir(®) (SOLVE(TM)) was a 24-week international observational study to evaluate the safety and effectiveness of initiating once-daily insulin detemir (Levemir) as add-on therapy in patients with type 2 diabetes mellitus (T2DM) who failed treatment of oral anti-diabetic drugs (OAD). METHODS: The present study was derived from the data of Chinese cohort. A total of 3272 patients with T2DM failing OAD were enrolled in the study. Determir were prescribed to the patients by the decision of the physician...
January 2013: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
Zachary M Novakovic, Matthew C Leinung, Patricia Grasso
The effects of oral delivery of exenatide or pramlintide acetate in dodecyl maltoside (DDM) on energy balance and glycemic control in insulin-resistant obese db/db mice are enhanced when given in combination with [D-Leu-4]-OB3. To examine the anti-hyperglycemic influence of [D-Leu-4]-OB3 in a non-obese insulin-deficient animal model, we compared the effects of metformin (200mg/kg) and [D-Leu-4]-OB3 (40 mg/kg) on energy balance and glycemic control in streptozotocin (STZ)-induced diabetic male Swiss Webster (SW) mice...
May 2013: Peptides
Eddy Karnieli, Florian M M Baeres, Grzegorz Dzida, Qiuhe Ji, Robert Ligthelm, Stuart Ross, Anne Louise Svendsen, Jean-François Yale
OBJECTIVES: Older patients are particularly vulnerable to hypoglycaemia. The aim of this study was to evaluate the response to initiation of once-daily insulin detemir in patients aged ≥75 years with type 2 diabetes mellitus (T2DM) treated with one or more oral antidiabetic drugs (OADs). METHODS: A sub-analysis was conducted using data from SOLVE (Study of Once daily LeVEmir), a 24-week observational study involving 3,219 investigators and 2,817 project sites from ten countries...
March 2013: Drugs & Aging
A Liebl, B Wilhelm, M Kaiser
BACKGROUND: Hypoglycemic risk and improved glycemic control have to be weightened when a decision on intensification of treatment of type 2 diabetes mellitus with basal insulin is made. Findings from randomized studies are available in this respect, and should be complemented by data from routine treatment. METHODS: The international, prospective, open-label, observational study SOLVE (Study of Once-Daily Levemir) investigated add-on treatment with basal insulin in type 2 diabetes mellitus using once daily insulin detemir in patients currently receiving oral antidiabetic drugs (OAD)...
December 17, 2012: MMW Fortschritte der Medizin
Gillian M Keating
Insulin detemir (Levemir®) is a long-acting insulin analogue indicated for use as basal insulin therapy in patients with type 1 or 2 diabetes mellitus. The protracted action of insulin detemir is explained by increased self-association and reversible binding to albumin, which slows its systemic absorption from the injection site. In glucose-clamp studies, less within-patient variability in glucose-lowering effect was seen with insulin detemir than with neutral protamine Hagedorn (NPH) insulin or insulin glargine in patients with type 1 or 2 diabetes...
December 3, 2012: Drugs
V Pandyarajan, M A Weiss
Structure-based protein design has enabled the engineering of insulin analogs with improved pharmacokinetic and pharmacodynamic properties. Exploiting classical structures of zinc insulin hexamers, the first insulin analog products focused on destabilization of subunit interfaces to obtain rapid-acting (prandial) formulations. Complementary efforts sought to stabilize the insulin hexamer or promote higher-order self-assembly within the subcutaneous depot toward the goal of enhanced basal glycemic control with reduced risk of hypoglycemia...
December 2012: Current Diabetes Reports
Mamatha Oduru, Mahmood Ahmad
A 52-year-old insulin-dependant diabetic man presented to the Emergency Department 2 hours after a deliberate massive overdose of 2100 units of long-acting Levemir insulin and a large quantity of whisky. On initial assessment, his GCS was 3/15 and his capillary blood sugar was 2.6 mmol/L. The patient was given a 50 ml bolus of 50% dextrose, followed by intravenous infusions of both 5% and 10% dextrose. Despite the continuous infusions, he experienced 4 symptomatic hypoglycaemic episodes in the first 12 hours after admission...
2012: Case Reports in Medicine
J Wolf, T Kapellen, R Stachow, W von Schütz, R Holl
Early morning hyperglycemia is frequent among children and adolescents with type 1 diabetes. Reasons are a dawn phenomenon, a Somogyi phenomenon or a lack of insulin in the morning hours. Only few studies are published regarding incidence and relation to different modes of basal insulin treatment in this population.We analyzed all cases recorded in the DPV register from 1995 to 2010. 5 839 patients from 128 centers with at least 3 blood glucose measurements during the last night of a hospital stay were included...
November 2012: Klinische Pädiatrie
Aditya Arya, Noori Al-Waili
There is an association between insulin analogues, glargine, lispro and aspart and the incidence of malignancies. A 76 year-old female patient with history of diabetes, hypertension and hyperlipidemia presented with flank pain after using insulin Levemir as part of her management. CT abdomen revealed pancreatic mass and endoscopic ultrasound- guided FNA aspiration biopsy showed pancreatic adenocarcinoma. It was not clear whether the insulin analogue initiated the tumor or helped the growth of pre-existing malignant foci...
August 2012: Journal of Clinical Medicine Research
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
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