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diabetes trials

Christine Aroney, Samantha Fraser-Bell, Ecosse L Lamoureux, Mark C Gillies, Lyndell L Lim, Eva K Fenwick
Purpose: To determine the patient-centered effectiveness of treatment with the slow-release dexamethasone intravitreal implant (DEX implant) and intravitreal bevacizumab using the Impact of Vision Impairment Questionnaire (IVI), a vision-related quality of life (VRQoL) measure, in patients with visual impairment secondary to center-involving diabetic macular edema (DME). Methods: Patients with DME were enrolled in a phase 2, prospective, multicenter, randomized, single-masked clinical trial and received either DEX implant 4 monthly or bevacizumab monthly, both pro re nata...
October 1, 2016: Investigative Ophthalmology & Visual Science
L Blonde, P Chava, T Dex, J Lin, E Nikonova, R Goldenberg
AIMS: To explore the treatment outcomes in adult patients with type 2 diabetes (T2D) enrolled in the GetGoal trials of lixisenatide (LIXI), and the predictive effects of baseline characteristics on outcomes. METHODS: This study was a pooled analysis of patient-level data from LIXI GetGoal studies comparing LIXI and placebo. Patients were divided into baseline therapy groups: oral antihyperglycaemic drugs (OADs) at baseline (n = 2,760) or basal insulin at baseline (n = 1,198)...
October 21, 2016: Diabetes, Obesity & Metabolism
Katherine R Tuttle, T Dwight McKinney, Jaime A Davidson, Greg Anglin, Kristine D Harper, Fady T Botros
Dulaglutide (DU) is a once-weekly glucagon-like peptide-1 receptor agonist approved for treatment of type 2 diabetes. Integrated data from 9 phase 2 and 3 trials in type 2 diabetes (N = 6005) were used to evaluate effects of DU on estimated glomerular filtration rate (eGFR, mL/min/1.73m(2) [Chronic Kidney Disease Epidemiology Collaboration]), urine albumin-to-creatinine ratio (UACR, mg/g), and kidney adverse events. No significant differences in eGFR were observed during treatment for DU versus placebo (PL), active comparators (AC), or insulin glargine (IG) (mean±SD; DU: 87...
October 21, 2016: Diabetes, Obesity & Metabolism
Susan L Samson, Alan J Garber
Incretin-based therapies are important addition to our armamentarium for the treatment of type 2 diabetes (T2DM). There are six Glucagon-like peptide-1 receptor agonists (GLP-1RAs) which have received regulatory approval for clinical use. The short-acting GLP-1RAs include exenatide twice daily, liraglutide once daily, and lixisenatide once daily. The approved long-acting GLP-1RAs are administered weekly and are exenatide, albiglutide, and dulaglutide. Although all of these therapies lower hemoglobin A1C (HbA1C), there also are unique features of GLP-1RAs that have been made manifest from clinical trial data with regard to weight-loss efficacy, fasting and post-prandial glucose control, cardiovascular safety and protection, and gastrointestinal and injection adverse effects...
December 2016: Current Diabetes Reports
M Bryant Howren, Jeffrey S Gonzalez
The current issue is devoted broadly to research on treatment adherence and chronic illness self-management behavior. As the prevalence of chronic illness increases, the pervasive problem of treatment nonadherence is increasingly viewed as having a major impact on treatment outcomes, public health and healthcare costs, making this issue particularly timely. Sixteen articles spanning an array of topics are presented; articles include empirical studies, statistical simulations, systematic reviews, and theoretical commentaries...
October 20, 2016: Journal of Behavioral Medicine
Anne M Murray, Fang-Chi Hsu, Jeff D Williamson, R Nick Bryan, Hertzel C Gerstein, Mark D Sullivan, Michael E Miller, Iris Leng, Laura L Lovato, Lenore J Launer
AIMS/HYPOTHESIS: The Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, a double 2x2 factorial parallel-group randomised clinical trial, tested whether intensive compared with standard management of hyperglycaemia, BP or lipid levels reduced cognitive decline and brain atrophy in 2977 people with type 2 diabetes. We describe the results of the observational extension study, ACCORDION MIND ( registration no. NCT00182910), which aimed to measure the long-term effects of the three ACCORD interventions on cognitive and brain structure outcomes approximately 4 years after the trial ended...
October 20, 2016: Diabetologia
Emily E Regier, Manu V Venkat, Kelly L Close
IN BRIEF Concerns raised about the cardiovascular safety of type 2 diabetes medications such as rosiglitazone prompted the U.S. Food and Drug Administration to issue draft guidance in 2008 that, in practice, has required large cardiovascular outcomes trials (CVOTs) for all new type 2 diabetes therapies. After more than 7 years and six completed and published trials to date, this is an opportune time to consider whether these studies, as currently designed and conducted, accurately assess the long-term benefit/risk profile of new therapies and whether they represent an optimal use of limited health care resources...
October 2016: Clinical Diabetes: a Publication of the American Diabetes Association
Stepana Boukalova, Jan Stursa, Lukas Werner, Zuzana Ezrova, Jiri Cerny, Ayenachew Bezawork-Geleta, Alena Pecinova, Lanfeng Dong, Zdenek Drahota, Jiri Neuzil
Pancreatic cancer is one of the hardest-to-treat types of neoplastic diseases. Metformin, a widely prescribed drug against type 2 diabetes mellitus, is being trialed as an agent against pancreatic cancer, although its efficacy is low. With the idea of delivering metformin to its molecular target, the mitochondrial complex I (CI), we tagged the agent with the mitochondrial vector, triphenylphosphonium group. Mitochondrially targeted metformin (MitoMet) was found to kill a panel of pancreatic cancer cells 3-4 orders of magnitude more efficiently than found for the parental compound...
October 7, 2016: Molecular Cancer Therapeutics
Morten Asser Karsdal, Kim Henriksen, Mette Juul Nielsen, Inger Byrjalsen, Diana Julie Leeming, Stephen Gardner, Zachary Goodman, Keyur Patel, Aleksander Krag, Claus Christiansen, Detlef Schuppan
BACKGROUND: There are no approved treatments for liver fibrosis. To aid development of anti-fibrotic therapies, non-invasive biomarkers that can identify patients with progressive fibrosis and that permit monitoring of the response to anti-fibrotic therapy are much needed. METHODS: Samples from a phase II anti-fibrotic trial of the glitazone farglitazar in patients with advanced hepatitis C, with matched follow-up liver biopsies, and from a phase III study of balaglitazone in late stage type 2 diabetics (BALLET study), were analysed for serological Pro-C3 levels in conjunction with other disease parameters...
October 20, 2016: American Journal of Physiology. Gastrointestinal and Liver Physiology
Joshua A Beckman, Allison B Goldfine, Jane A Leopold, Mark A Creager
Oxidative stress is a key driver of vascular dysfunction in diabetes mellitus. Ebselen is a glutathione-peroxidase mimetic. A single-site, randomized, double-masked, placebo-controlled crossover trial in 26 subjects with either type 1 or type 2 diabetes to evaluate effects of high-dose ebselen (150 mg orally twice daily) administration on oxidative stress and endothelium-dependent vasodilation. Treatment periods were in random order of 4 weeks duration, with a 4 week washout between. Measures of oxidative stress included nitrotyrosine, plasma 8-isoprostanes, and the ratio of reduced-to-oxidized glutathione...
October 7, 2016: American Journal of Physiology. Heart and Circulatory Physiology
Wilson Kc Leung, L Gao, Parco M Siu, Christopher Wk Lai
An explosion in global epidemic of type 2 diabetes mellitus poses major rise in cases with vascular endothelial dysfunction ranging from micro- (retinopathy, nephropathy and neuropathy) to macro-vascular (atherosclerosis and cardiomyopathy) conditions. Functional destruction of endothelium is regarded as an early event that lays the groundwork for the development of renal microangiopathy and subsequent clinical manifestation of nephropathic symptoms. Recent research has shed some light on the molecular mechanisms of type 2 diabetes-associated comorbidity of endothelial dysfunction and nephropathy...
October 17, 2016: Life Sciences
Alexander N Shikov, Olga N Pozharitskaya, Valery G Makarov
PURPOSE: Aralia elata var. mandshurica (Rupr. & Maxim.) J.Wen syn. A. mandshurica Rupr. & Maxim is evaluated for its medicinal application. The aim of this study is to analyze pharmacological studies on A. elata var. mandshurica published until December 2015. METHODS: The information regarding the chemistry, safety, effectiveness, and pharmacological and clinical effects of A. elata was systematically collected from the scientific literature through library catalogs; online services such as E-library...
November 15, 2016: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
Bin Shen, Yu Zhang, Wei Dai, Yupo Ma, Yongping Jiang
BACKGROUND: Hematopoietic CD34(+) stem cells are widely used in the clinical therapy of complicated blood diseases. Stem cell factor Sall4B is a zinc finger transcription factor that plays a vital role in hematopoietic stem cell expansion. The purpose of our current study is to further evaluate how Sall4B might affect the expansion of CD34(+) cells derived from nonhuman primates. METHODS: Sall4B was overexpressed in nonhuman primate bone marrow-derived CD34(+) cells via a lentiviral transduction system...
October 20, 2016: Stem Cell Research & Therapy
Annie L Nguyen, Tingjian Yan, Kathleen Ell, Jorge Gonzalez, Susan Enguidanos
OBJECTIVE: Latinos are disproportionately affected by diabetes and people with diabetes experience frequent hospital admissions and readmissions. Care transition interventions can help reduce rates of readmission; however, there are many barriers to recruiting Latinos for participation in intervention research. Exploring reasons for study refusal furthers understanding of low research participation rates to help researchers address barriers. DESIGN: This study presents a cross-sectional, descriptive analysis of reasons for study refusal and attrition drawing from data collected as part of a randomized controlled trial conducted to test the effectiveness of a transitions intervention for diabetic Latino discharged from the hospital to home...
October 21, 2016: Ethnicity & Health
D Bogdanou, M Penna-Martinez, N Filmann, T L Chung, Y Moran-Auth, J Wehrle, C Cappel, S Huenecke, E Herrmann, U Koehl, K Badenhoop
BACKGROUND: Type 1 diabetes mellitus (T1D) is mediated by autoaggressive T effector cells with an underlying regulatory T cell (Treg) defect. Vitamin D (VD) deficiency is highly prevalent in T1D which can aggravate immune dysfunction. High dose VD treatment may enhance Tregs and improve metabolism in T1D patients. METHODS: In a randomized, double-blind, placebo-controlled trial with cross-over design, patients received either for three months cholecalciferol 4000 IU/d, followed by three months placebo or the sequential alternative...
October 20, 2016: Diabetes/metabolism Research and Reviews
A Muruganathan, Mangesh Tiwaskar
While the incidence and prevalence of stroke is gradually decreasing in the western world, a parallel increase is seen in the developing world. It is a matter of special concern to us as approximately 20-30% of stroke occur in people younger than 45 years in India. Indians are prone to higher stroke risk because of urbanization, diabetes, cigarette smoking and high incidence of hypertension. Unfortunately, there is an inadequate awareness about the risk of stroke with hypertension among general public. Hypertension is considered to be the most important risk factor for stroke, and all forms of hypertension are associated with an increased risk of both ischemic and haemorrhagic stroke...
September 2016: Journal of the Association of Physicians of India
Bhavana Sosale, Aravind R Sosale, Prassanna M Kumar, Shashank R Joshi
BACKGROUND AND AIM: The number of patients with type 2 diabetes (T2DM) is increasing. Most patients with T2DM are uncontrolled and fail to achieve their target Hba1c. In recent years, newer agents such as SGLT2 inhibitors (SGLT2i) have been approved for clinical use. Though data from clinical trials and sub set analysis of Indian patients in global studies are promising, real world evidence from standard clinical practice in India is lacking. The aim of this study was to analyze the metabolic parameters in patients with T2DM on SGLT2i in real world clinical practice...
September 2016: Journal of the Association of Physicians of India
Fabio Broglio, Edoardo Mannucci, Raffaele Napoli, Antonio Nicolucci, Francesco Purrello, Elena Nikonova, William Stager, Roberto Trevisan
AIMS: To evaluate long term efficacy and safety of lixisenatide, a short-acting, prandial GLP-1 RA (Glucagon-Like Peptide-1 Receptor Agonists) as add-on therapy in type 2 diabetes mellitus. METHODS: A meta-analysis of 76-week results of five placebo-controlled clinical trials from the GetGoal program was performed including 3,000 inadequately controlled adult diabetic patients where lixisenatide 20 µg once-daily was administered in combination with metformin (GetGoal-M and GetGoal-F1), sulphonylurea ± metformin (GetGoal-S), basal insulin ± metformin (GetGoal-L) or pioglitazone ± metformin (GetGoal-P)...
October 20, 2016: Diabetes, Obesity & Metabolism
Francisco J Tinahones, Baptist Gallwitz, Matias Nordaby, Sophia Götz, Mario Maldonado-Lutomirsky, Hans J Woerle, Uli C Broedl
AIM: To evaluate the efficacy and safety of linagliptin versus placebo as add-on to empagliflozin and metformin in patients with type 2 diabetes. MATERIALS AND METHODS: Patients with inadequate glycaemic control despite stable-dose metformin received open-label empagliflozin 10 mg (study 1) or 25 mg (study 2) as add-on therapy for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (>53 and ≤91 mmol/mol) (N = 482) were randomized to 24 weeks' double-blind, double-dummy treatment with linagliptin 5 mg or placebo in study 1, or linagliptin 5 mg or placebo in study 2; all patients continued treatment with metformin and empagliflozin 10 mg (study 1) or metformin and empagliflozin 25 mg (study 2)...
October 20, 2016: Diabetes, Obesity & Metabolism
Tongzhi Wu, Cong Xie, Hang Wu, Karen L Jones, Michael Horowitz, Christopher K Rayner
In rodents, metformin slows intestinal glucose absorption, potentially increasing exposure of the distal gut to glucose to enhance postprandial glucagon-like peptide-1 (GLP-1) secretion. We evaluated the effects of metformin on serum 3-O-methylglucose (3-OMG, a marker of glucose absorption) and plasma total GLP-1 concentrations during a standardised intraduodenal infusion of glucose and 3-OMG in patients with type 2 diabetes. 12 patients, treated with metformin 850 mg bd or placebo each for 7 days in a double-blind, randomised, crossover design (14 days 'washout' between treatments), were evaluated on days 5 or 8 of each treatment (6 each)...
October 20, 2016: Diabetes, Obesity & Metabolism
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