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New diabetes trials

Soo Lim, Robert H Eckel, Kwang Kon Koh
The final goal in the management of patients with type 2 diabetes (T2D) is reduction in cardiovascular (CV) complications and total mortality. Various factors including hyperglycemia contribute to these complications and mortality directly and indirectly. In recent years, large-scale CV outcome trials with new antidiabetic medications, such as dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP1) receptor agonists, and sodium glucose cotransporter-2 (SGLT2) inhibitors, have been completed...
March 8, 2018: Atherosclerosis
Brendan M Everett, Marc Y Donath, Aruna D Pradhan, Tom Thuren, Prem Pais, Jose C Nicolau, Robert J Glynn, Peter Libby, Paul M Ridker
BACKGROUND: Subclinical inflammation mediated in part by interleukin-1 beta (IL-1β) participates in peripheral insulin resistance and impaired pancreatic insulin secretion. OBJECTIVES: We tested the hypothesis that canakinumab, an IL-1β inhibitor, reduces incident diabetes. METHODS: The Canakinumab Antiinflammatory Thrombosis Outcomes Study (CANTOS) randomized 10,061 patients with prior MI and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L to placebo or canakinumab at doses of 50mg, 150mg, or 300mg subcutaneously once every three months...
March 3, 2018: Journal of the American College of Cardiology
Tanya Moutray, Jennifer R Evans, Noemi Lois, David J Armstrong, Tunde Peto, Augusto Azuara-Blanco
BACKGROUND: Diabetic retinopathy (DR) is a chronic progressive disease of the retinal microvasculature associated with prolonged hyperglycaemia. Proliferative DR (PDR) is a sight-threatening complication of DR and is characterised by the development of abnormal new vessels in the retina, optic nerve head or anterior segment of the eye. Argon laser photocoagulation has been the gold standard for the treatment of PDR for many years, using regimens evaluated by the Early Treatment of Diabetic Retinopathy Study (ETDRS)...
March 15, 2018: Cochrane Database of Systematic Reviews
Mikhail Kosiborod, Carolyn S P Lam, Shun Kohsaka, Dae Jung Kim, Avraham Karasik, Jonathan Shaw, Navdeep Tangri, Su-Yen Goh, Marcus Thuresson, Hungta Chen, Filip Surmont, Niklas Hammar, Peter Fenici
BACKGROUND: Randomized trials demonstrated lower risk of cardiovascular (CV) events with sodium-glucose cotransporter-2 inhibitors (SGLT-2i) in patients with type 2 diabetes (T2D) at high CV risk. Prior real-world data suggested similar SGLT-2i effects in T2D patients with broader risk profile, but focused on heart failure and death, and were limited to US and Europe. OBJECTIVES: To examine a broad range of CV outcomes in patients initiated on SGLT-2i vs. other glucose lowering drugs (oGLD) across six countries in Asia Pacific, Middle East and North America (NCT02993614)...
March 7, 2018: Journal of the American College of Cardiology
Tiffany L Gary-Webb, Elizabeth A Walker, Lindsey Realmuto, Alexandra Kamler, Jennifer Lukin, William Tyson, Olveen Carrasquillo, Linda Weiss
The Diabetes Prevention Program (DPP) landmark randomized trial demonstrated that participants with prediabetes could reduce their risk for type 2 diabetes by 58% if they achieved 5%-7% weight loss through healthy eating and increasing physical activity. The National DPP (NDPP) is a group intervention based on the DPP and has been widely disseminated by the Centers for Disease Control and Prevention (CDC) and many healthcare institutions. While data show that the program is effective in diverse populations, enrollment among men from low-income and minority communities is low...
March 1, 2018: American Journal of Men's Health
Fen Chen, Shulin Li, Dong Sun
Blood oxygen level-dependent magnetic resonance imaging (BOLD MRI) has recently been utilized as a noninvasive tool for evaluating renal oxygenation. Several methods have been proposed for analyzing BOLD images. Regional ROI selection is the earliest and most widely used method for BOLD analysis. In the last 20 years, many investigators have used this method to evaluate cortical and medullary oxygenation in patients with ischemic nephropathy, hypertensive nephropathy, diabetic nephropathy, chronic kidney disease (CKD), acute kidney injury and renal allograft rejection...
March 8, 2018: Kidney & Blood Pressure Research
Laura Van den Mooter, Simon Caerels, Chantal Mathieu
There is a clear unmet clinical need in people with Type 1 diabetes (T1DM) considering present day insulin therapy. New insulin analogues and novel technologies allowing more tailored insulin administration have improved the quality of life of people with T1DM, but issues like hypoglycemia, weight gain and variability in glucose profiles remain problematic. Areas covered: In this review, the clinical efficacy, safety and tolerability of dapagliflozin, a sodium-glucose cotransporter type 2 inhibitor, in type 1 diabetes (T1DM) is described based on a review of phase 2 and 3 studies to date...
March 14, 2018: Expert Opinion on Pharmacotherapy
Ippei Ikushima, Lene Jensen, Anne Flint, Tomoyuki Nishida, Jeppe Zacho, Shin Irie
INTRODUCTION: Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects. METHODS: In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0...
March 13, 2018: Advances in Therapy
Marisa E Hilliard, Sahar S Eshtehardi, Charles G Minard, Rana Saber, Debbe Thompson, Lefkothea P Karaviti, Yuliana Rojas, Barbara J Anderson
BACKGROUND: Supportive parent involvement for adolescents' type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. OBJECTIVE: The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well...
March 13, 2018: JMIR Research Protocols
Siti Khuzaimah Ahmad Sharoni, Hejar Abdul Rahman, Halimatus Sakdiah Minhat, Sazlina Shariff-Ghazali, Mohd Hanafi Azman Ong
BACKGROUND: Self-care behaviour is essential in preventing diabetes foot problems. This study aimed to evaluate the effectiveness of health education programs based on the self-efficacy theory on foot self-care behaviour for older adults with diabetes. METHODS: A randomised controlled trial was conducted for 12 weeks among older adults with diabetes in elderly care facility in Peninsular Malaysia. Six elderly care facility were randomly allocated by an independent person into two groups (intervention and control)...
2018: PloS One
Scott E Kasner, Pablo Lavados, Mukul Sharma, Yongjun Wang, Yilong Wang, Antoni Dávalos, Nikolay Shamalov, Luis Cunha, Arne Lindgren, Robert Mikulik, Antonio Arauz, Wilfried Lang, Anna Czlonkowska, Jens Eckstein, Rubens Gagliardi, Pierre Amarenco, Sebastián F Ameriso, Turgut Tatlisumak, Roland Veltkamp, Graeme J Hankey, Danilo S Toni, Daniel Bereczki, Shinichiro Uchiyama, George Ntaios, Byung-Woo Yoon, Raf Brouns, M M DeVries Basson, Matthias Endres, Keith Muir, Natan Bornstein, Serefnur Ozturk, Martin O'Donnell, Hardi Mundl, Calin Pater, Jeffrey Weitz, W Frank Peacock, Balakumar Swaminathan, Bodo Kirsch, Scott D Berkowitz, Gary Peters, Guillaume Pare, Ellison Themeles, Ashkan Shoamanesh, Stuart J Connolly, Robert G Hart
BACKGROUND: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. AIMS: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. METHODS: We enrolled 7213 patients at 459 sites in 31 countries...
March 7, 2018: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Xia Dai, Zu-Chun Luo, Lu Zhai, Wen-Piao Zhao, Feng Huang
INTRODUCTION: Empagliflozin is a new, emerging oral hypoglycemic agent (OHA) which has shown significant benefits in type 2 diabetes mellitus (T2DM) patients with cardiovascular disease. In this analysis, our aim was to systematically compare the adverse drug events (ADEs) associated with a low (10 mg) versus a high (25 mg) dose of empagliflozin as (1) monotherapy, (2) as an add-on to other OHAs, and (3) as an add-on specifically to metformin, in patients who were treated for T2DM. METHODS: This was a systematic review and meta-analysis of randomized controlled trials that compared empagliflozin 10 mg versus 25 mg in patients who were treated for T2DM and which reported adverse drug reactions as their clinical endpoints...
March 9, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Anna Zuk, Paul M Palevsky, Linda Fried, Frank E Harrell, Samina Khan, Dianne B McKay, Luke Devey, Lakhmir Chawla, Mark de Caestecker, James S Kaufman, B Taylor Thompson, Anupam Agarwal, Tom Greene, Mark Douglas Okusa, Joseph V Bonventre, Laura M Dember, Kathleen D Liu, Benjamin D Humphreys, Daniel Gossett, Yining Xie, Jenna M Norton, Paul L Kimmel, Robert A Star
AKI is a complex clinical condition associated with high mortality, morbidity, and health care costs. Despite improvements in methodology and design of clinical trials, and advances in understanding the underlying pathophysiology of rodent AKI, no pharmacologic agent exists for the prevention or treatment of AKI in humans. To address the barriers that affect successful clinical translation of drug targets identified and validated in preclinical animal models of AKI in this patient population, the National Institute of Diabetes and Digestive and Kidney Diseases convened the "AKI Outcomes: Overcoming Barriers in AKI" workshop on February 10-12, 2015...
March 9, 2018: Clinical Journal of the American Society of Nephrology: CJASN
W Masson, M Lobo, D Siniawski, M Huerín, G Molinero, R Valéro, J P Nogueira
BACKGROUND: Cholesteryl ester transfer protein (CETP) inhibitors are a class of drugs that targets the CETP enzyme to significantly increase serum high-density lipoprotein cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) levels. As HDL-C has potential antidiabetic properties, and the beneficial effects of CETP drugs on glucose homoeostasis have not been sufficiently studied, the aims of this study were: (1) to evaluate the effect of CETP inhibitors on the incidence of diabetes; and (2) to assess the association between CETP inhibitor-induced changes in HDL-C levels and incidence of diabetes...
February 20, 2018: Diabetes & Metabolism
Nora Luethi, Luca Cioccari, Peter Biesenbach, Luca Lucchetta, Hidetoshi Kagaya, Rhys Morgan, Francesca Di Muzio, Barbara Presello, Duaa Gaafar, Alison Hay, Marco Crisman, Roisin Toohey, Hollie Russell, Neil J Glassford, Glenn M Eastwood, Elif I Ekinci, Adam M Deane, Rinaldo Bellomo, Johan Mårtensson
OBJECTIVES: To assess the feasibility, biochemical efficacy, and safety of liberal versus conventional glucose control in ICU patients with diabetes. DESIGN: Prospective, open-label, sequential period study. SETTING: A 22-bed mixed ICU of a tertiary hospital in Australia. PATIENTS: We compared 350 consecutive patients with diabetes admitted over 15 months who received liberal glucose control with a preintervention control population of 350 consecutive patients with diabetes who received conventional glucose control...
March 3, 2018: Critical Care Medicine
Hiroki Nakajima, Sadanori Okada, Takako Mohri, Eiichiro Kanda, Naoyuki Inaba, Yoko Hirasawa, Hiroaki Seino, Hisamoto Kuroda, Toru Hiyoshi, Tetsuji Niiya, Hitoshi Ishii
Background: The benefits of sodium glucose cotransporters 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus include plasma glucose control, reduction in body weight and blood pressure, and low risk of hypoglycemia, although they may also cause genitourinary infections, polyuria, or volume depletion. It is not clear whether dapagliflozin, an SGLT2 inhibitor, improves treatment satisfaction among patients in a comprehensive way despite the negative side effects. This study assessed the effect of dapagliflozin on glycosylated hemoglobin (HbA1c), body weight, and treatment satisfaction in overweight patients with type 2 diabetes mellitus treated with oral hypoglycemic agents...
2018: Diabetology & Metabolic Syndrome
John Grundy, Kon Mouzakis, Rajesh Vasa, Andrew Cain, Maheswaree Curumsing, Mohamed Abdelrazek, Niroshine Fernando
By the 2050, it is estimated that the proportion of people over the age of 80 will have risen from 3.9% to 9.1% of population of Organisation for Economic Cooperation and Development countries. A large proportion of these people will need significant help to manage various chronic illnesses, including dementia, heart disease, diabetes, limited physical movement and many others. Current approaches typically focus on acute episodes of illness and are not well designed to provide adequately for daily living care support...
2018: Studies in Health Technology and Informatics
D Li, J Yufeng Yang, T Wang, S Shen, H Tang
BACKGROUND: The U.S. Food and Drug Administration recently issued a safety communication requiring new warnings of increased leg and foot amputation risk be added to canagliflozin drug labelling. However, the risk associated with other sodium-glucose co-transporter 2 inhibitors (SGLT2i) remains uncertain. AIM: This meta-analysis aimed to evaluate the potential risks of diabetic foot syndrome (DFS) and amputation associated with SGLT2i. METHODS: Relevant databases were searched from inception to June 14, 2017 to identify randomized controlled trials (RCTs) that evaluated risks of DFS and amputation associated with SGLT2i use...
February 13, 2018: Diabetes & Metabolism
Diana Sarfati, Melissa McLeod, James Stanley, Virginia Signal, Jeannine Stairmand, Jeremy Krebs, Anthony Dowell, William Leung, Cheryl Davies, Rebecca Grainger
BACKGROUND: Long-term conditions (LTCs) are the biggest contributor to health loss in New Zealand. The economic cost and burden on the health system is substantial and growing. Self-management strategies offer a potential way to reduce the pressure on health services. This study evaluates a comprehensive self-management programme (the BetaMe programme) delivered by mobile and web-based technologies for people with Type 2 diabetes (T2DM) and pre-diabetes. The primary aim of this study is to evaluate the effectiveness of the BetaMe programme versus usual care among primary care populations in improving the control of T2DM and pre-diabetes, as measured by change in HbA1c and weight over 12 months...
March 5, 2018: Trials
Rachel J Fenske, Michelle E Kimple
Since its discovery and purification by Frederick Banting in 1921, exogenous insulin has remained almost the sole therapy for type 1 diabetes mellitus. While insulin alleviates the primary dysfunction of the disease, many other aspects of the pathophysiology of type 1 diabetes mellitus are unaffected. Research aimed towards the discovery of novel type 1 diabetes mellitus therapeutics targeting different cell signaling pathways is gaining momentum. The focus of these efforts has been almost entirely on the impact of immunomodulatory drugs, particularly those that have already received FDA-approval for other autoimmune diseases...
January 1, 2018: Experimental Biology and Medicine
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