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Joanna Zielińska, Jacek Stadnik, Anna Bierczyńska-Krzysik, Dorota Stadnik
PURPOSE: Isolation and identification of unknown impurities of recombinant insulin lispro (produced at IBA) formed during accelerated stability testing of pharmaceutical solutions. For comparative purposes also commercially available formulations of recombinant human insulin (Humulin S®; Lilly), recombinant insulin lispro (Humalog®; Lilly), recombinant insulin aspart (NovoRapid® Penfill®; Novo Nordisk), recombinant insulin detemir (Levemir®; Novo Nordisk) and recombinant insulin glargine (Lantus®; Sanofi-Aventis) were analyzed...
May 16, 2018: Pharmaceutical Research
V Limani
Gestational diabetes mellitus (GDM) occurs in 2-9% of all pregnancies. Evidence suggests that the use of insulin in treating hyperglycemia in GDM patients reduces the risk of perinatal morbidity. Pregnancy is an exciting time in a woman's life. However, once patient is diagnosed with GDM, she will be managed more intensively. GDM is managed using diet and exercise but one in six women with GDM requires insulin. A 35-year-old woman at the 14th gestational week of her tenth pregnancy was seen for routine prenatal care...
April 2018: Georgian Medical News
Ke-Qiang He, Wei-Zu Li, Xiao-Qing Chai, Yan-Yan Yin, Yan Jiang, Wei-Ping Li
Diabetic patients are able to manage their blood glucose with exogenous insulin but, ultimately, remain at risk of diabetic nephropathy (DN). Long‑term use of insulin may lead to iatrogenic hyperinsulinemia, which has been suggested to cause kidney injury. However, there are no effective interventions for iatrogenic hyperinsulinemia leading to kidney damage. In the present paper, the hypothesis that astragaloside IV (AS‑IV), a novel saponin purified from Astragalus membranaceus (Fisch) Bunge, may prevent DN in iatrogenic hyperinsulinemic diabetic rats through antioxidative and anti‑inflammatory mechanisms was investigated...
February 2018: International Journal of Molecular Medicine
Ana María Gómez, Santiago Vallejo, Freddy Ardila, Oscar M Muñoz, Álvaro J Ruiz, Mauricio Sanabria, Alfonso Bunch, Elly Morros, Laura Kattah, Maira García-Jaramillo, Fabián León-Vargas
INTRODUCTION: Clinical interventional studies in diabetes mellitus usually exclude patients undergoing peritoneal dialysis (PD). This study evaluates the impact of an educational program and a basal-bolus insulin regimen on the blood glucose level control and risk of hypoglycemia in this population. METHODS: A before-and-after study was conducted in type 1 and type 2 DM patients undergoing PD at the Renal Therapy Services (RTS) clinic network, Bogota, Colombia. An intervention was instituted consisting of a three-month educational program and a basal-bolus detemir (Levemir, NovoNordisk) and aspart (Novorapid, NovoNordisk) insulin regimen...
January 2018: Journal of Diabetes Science and Technology
Vivek-Thomas J Sankoorikal, Janet Ricks
A 47-year-old white male with a 5-year history of type 2 diabetes mellitus presented to clinic with uncontrolled hyperglycemia, weight loss, and body aches that impeded his ability to work and sleep. He had initially controlled his diabetes successfully with weight loss and exercise. However, in the previous 6 months he had noticed unintentional weight loss. He was evaluated at another clinic where he was prescribed sitagliptin/metformin (Janumet) for his uncontrolled hyperglycemia. After 6 weeks his blood glucose had not significantly improved, and an endocrinologist prescribed insulin glargine (Lantus) and insulin aspart (NovoLog)...
July 2016: Journal of the Mississippi State Medical Association
Andreas Pfützner, Gidi Pesach, Ron Nagar
BACKGROUND: Injectable life-saving drugs should not be exposed to temperatures <4°C/39°F or >30°C/86°F. Frequently, weather conditions exceed these temperature thresholds in many countries. Insulin is to be kept at 4-8°C/~ 39-47°F until use and once opened, is supposed to be stable for up to 31 days at room temperature (exception: 42 days for insulin levemir). Extremely hot or cold external temperature can lead to insulin degradation in a very short time with loss of its glucose-lowering efficacy...
June 2017: Expert Opinion on Drug Delivery
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...
October 2, 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
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