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Novo Nordisk

Nabil El Naggar, Sanjay Kalra
: Diabetes is a growing public health concern. Effective use of therapies for this chronic disease is necessary to improve long-term prognosis, but treatment adherence can be difficult to promote in clinical practice, and insulin, in particular, can impact both positively and negatively on patients' quality of life (QoL). Currently, guidelines advocate for QoL as a treatment goal in its own right, with treatment decisions based on patient concerns regarding injection frequency and adverse events, as well as glycemic control...
October 13, 2016: Advances in Therapy
Matthias M Weber, Beverly Mk Biller, Birgitte Tønnes Pedersen, Effie Pournara, Jens Sandahl Christiansen, Charlotte Höybye
OBJECTIVE: To assess the effect of 4 years' GH replacement on glucose homeostasis and evaluate factors affecting glycosylated haemoglobin (HbA1c ) in adults with GH deficiency (GHD). DESIGN: NordiNet(®) International Outcome Study, a non-interventional study, monitors long-term effectiveness and safety of GH-replacement (Norditropin(®) [somatropin], Novo Nordisk A/S) in real-life clinical practice. PATIENTS: Non-diabetic patients (n=245) with adult-onset GHD (age ≥20 years at GH start), ≥4 years' GH replacement and HbA1c values at baseline and 4 years were included in the analysis...
October 13, 2016: Clinical Endocrinology
Thomas S Voss, Mikkel H Vendelbo, Ulla Kampmann, Steen B Pedersen, Thomas S Nielsen, Mogens Johannsen, Mads V Svart, Niels Jessen, Niels Møller
AIMS/HYPOTHESIS: The aims of this study were to determine the role of lipolysis in hypoglycaemia and define the underlying intracellular mechanisms. METHODS: Nine healthy volunteers were randomised to treatment order of three different treatments (crossover design). Treatments were: (1) saline control; (2) hyperinsulinaemic hypoglycaemia (HH; i.v. bolus of 0.1 U/kg insulin); and (3) hyperinsulinaemic euglycaemia (HE; i.v. bolus of 0.1 U/kg insulin and 20% glucose)...
October 12, 2016: Diabetologia
Michelle Downie, Gary Kilov, Jencia Wong
: The progressive nature of type 2 diabetes (T2D) often results in the need for initiation and subsequent intensification of insulin treatment to achieve glycemic control. The aim of this review is to examine published clinical evidence that has directly compared two recommended treatment approaches in patients with T2D: (1) a 'basal plus' regimen, whereby 1-2 injections of prandial insulin are added to basal insulin; or (2) the use of once- or twice-daily premix insulin analogs, which contain both basal and prandial insulin in a single injection...
September 22, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Steven P Marso, Stephen C Bain, Agostino Consoli, Freddy G Eliaschewitz, Esteban Jódar, Lawrence A Leiter, Ildiko Lingvay, Julio Rosenstock, Jochen Seufert, Mark L Warren, Vincent Woo, Oluf Hansen, Anders G Holst, Jonas Pettersson, Tina Vilsbøll
Background Regulatory guidance specifies the need to establish cardiovascular safety of new diabetes therapies in patients with type 2 diabetes in order to rule out excess cardiovascular risk. The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an extended half-life of approximately 1 week, in type 2 diabetes are unknown. Methods We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks...
September 15, 2016: New England Journal of Medicine
Nandu Thalange, Abdullah Bereket, Lisbeth Bjerring Jensen, Line Conradsen Hiort, Valentina Peterkova
BACKGROUND: To study the long-term development (104 weeks) of insulin antibodies during treatment with insulin detemir (IDet) and insulin aspart (IAsp) in children with type 1 diabetes aged 2-16 years. METHODS: A 52-week, two-arm, randomized trial comparing IDet and neutral protamine Hagedorn insulin, both in combination with IAsp, was followed by a one-arm, 52-week extension trial of the IDet + IAsp arm. The present analysis was conducted in children who completed the randomized trial and entered into the extension trial...
September 6, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Marc Evans, Jens Gundgaard, Brian Bekker Hansen
INTRODUCTION: To evaluate the cost-effectiveness of the co-formulation insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart (BIAsp 30), both administered twice daily, in patients with type 2 diabetes mellitus (T2DM), using a short-term cost-effectiveness model. METHODS: Data from two phase 3a treat-to-target clinical trials were used to populate a simple and transparent short-term cost-effectiveness model. The costs and effects of treatment with IDegAsp versus BIAsp 30 were calculated over a 5-year period, from a Danish health-care cost perspective...
August 23, 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Agnete Kirkeby, Thomas Perlmann, Carlos-Filipe Pereira
The third 'Stem Cell Niche' meeting, supported by The Novo Nordisk Foundation, was held this year on May 22-26 and brought together 185 selected participants from 24 different countries to Hillerød, Denmark. Diverse aspects of embryonic and adult stem cell biology were discussed, including their respective niches in ageing, disease and regeneration. Many presentations focused on emerging technologies, including single-cell analysis, in vitro organogenesis and direct reprogramming. Here, we summarize the data presented at this exciting and highly enjoyable meeting, where speakers as well as kitchen chefs were applauded at every session...
August 15, 2016: Development
Peter Gæde, Jens Oellgaard, Bendix Carstensen, Peter Rossing, Henrik Lund-Andersen, Hans-Henrik Parving, Oluf Pedersen
AIMS/HYPOTHESIS: The aim of this work was to study the potential long-term impact of a 7.8 years intensified, multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria in terms of gained years of life and years free from incident cardiovascular disease. METHODS: The original intervention (mean treatment duration 7.8 years) involved 160 patients with type 2 diabetes and microalbuminuria who were randomly assigned (using sealed envelopes) to receive either conventional therapy or intensified, multifactorial treatment including both behavioural and pharmacological approaches...
November 2016: Diabetologia
Diana Isaacs, Lalita Prasad-Reddy, Sneha Baxi Srivastava
PURPOSE: Published data on the weight loss effects of glucagon-like peptide 1 (GLP-1) receptor agonists are reviewed, with a focus on data from clinical trials. SUMMARY: Obesity is a significant health problem in the United States (an estimated 69% of U.S. adults are overweight and nearly 35% are obese), and few drugs have proven safety and efficacy as adjuncts to lifestyle modification for weight management. GLP-1 receptor agonists are used for glycemic control in patients with type 2 diabetes and have been studied for their weight loss effects in patients with and without diabetes; these agents produce weight loss benefits through their effects on satiety and gastric emptying...
October 1, 2016: American Journal of Health-system Pharmacy: AJHP
Martin Blomberg Jensen, Jacob Gerner Lawaetz, Anna-Maria Andersson, Jørgen Holm Petersen, Loa Nordkap, Anne Kirstine Bang, Pia Ekbom, Ulla Nordström Joensen, Lisbeth Prætorius, Peter Lundstrøm, Vibeke Hartvig Boujida, Beate Lanske, Anders Juul, Niels Jørgensen
STUDY QUESTION: Are low vitamin D levels linked with semen quality and sex steroids in infertile men? SUMMARY ANSWER: Infertile men with vitamin D deficiency had lower sperm motility, total numbers of motile sperm, Inhibin B, sex-hormone-binding-globulin (SHBG) and testosterone/estradiol ratio, but higher levels of free sex steroids, than infertile men with normal vitamin D levels. WHAT IS KNOWN ALREADY: Low vitamin D levels have been associated with decreased sperm motility in healthy men, but a relationship between vitamin D and calcium with semen quality and especially sex steroids has not been sufficiently described in infertile men...
August 2016: Human Reproduction
Amrita Ostawal, Emina Mocevic, Nana Kragh, Weiwei Xu
INTRODUCTION: In clinical trials, liraglutide has proven to be an effective drug for the treatment of type 2 diabetes mellitus (T2DM). The real-world effectiveness of liraglutide has been investigated in numerous studies. The aim of this systematic literature review is to collate evidence on the real-world clinical effectiveness of liraglutide. METHODS: A review of publications from Medline, EMBASE, the Cochrane Library, and conference proceedings was conducted to identify observational studies that assessed the clinical effectiveness of liraglutide in real-world clinical practice...
September 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Steven P Marso, Gilbert H Daniels, Kirstine Brown-Frandsen, Peter Kristensen, Johannes F E Mann, Michael A Nauck, Steven E Nissen, Stuart Pocock, Neil R Poulter, Lasse S Ravn, William M Steinberg, Mette Stockner, Bernard Zinman, Richard M Bergenstal, John B Buse
BACKGROUND: The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. METHODS: In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke...
July 28, 2016: New England Journal of Medicine
Meryl Brod, Annie Nikolajsen, James Weatherall, Kathryn M Pfeiffer
INTRODUCTION: To explore how patients with diabetes experience post-prandial hyperglycemia (PPH) or elevated blood glucose (BG) following a meal. METHODS: A web-based survey of patients with type 1 or type 2 diabetes using bolus insulin in Germany, the USA, and the UK was conducted. RESULTS: A total of 906 respondents completed the survey. PPH was a frequent occurrence among patients with type 1 and type 2 diabetes; 61.9% of respondents had experienced PPH in the past week, and differences by diabetes type were not significant...
June 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Marcus Lind, Per-Olov Matsson, Ragnar Linder, Irene Svenningsson, Leif Jørgensen, Uffe J Ploug, Helge Gydesen, Mozhgan Dorkhan, Sara Larsen, Gunnar Johansson
INTRODUCTION: The aim of the present study was to use real-world data from Swedish primary-care and national registries to understand clinical outcomes in patients with Type 2 diabetes (T2D) treated with liraglutide in clinical practice, and to compare with data from those treated with sitagliptin. METHODS: This was a non-interventional, retrospective study conducted between February 2014 and September 2014 using T2D patient data from Swedish primary-care centers and national healthcare registries...
June 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Dalit Goldstein, Gabriel Chodick, Varda Shalev, Brian L Thorsted, Lisa Elliott, Avraham Karasik
INTRODUCTION: Severe hypoglycemia is a burden for both patients and the healthcare system payer alike. This study aimed to quantify the resource use associated with a severe hypoglycemic event (SHE) in patients with diabetes. METHODS: This retrospective cohort study compared resource use (e.g., physician visits, hospitalizations, and medications) 1 month pre- and post-SHE among patients with type 1 (T1D) or type 2 diabetes (T2D) from a large not-for-profit healthcare provider...
June 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Saud Al Sifri, Kashif Rizvi
UNLABELLED: Muslim patients with type 2 diabetes (T2D) who fast during Ramadan face challenges in diabetes management due to substantial alterations in lifestyle and treatment that frequently accompany the decision to fast. International guidelines for treating T2D do not fully address the clinical issues unique to fasting, and other guidance documents lack the large and high-quality evidence base available for non-fasting conditions. We reviewed 10 randomized controlled trials and 20 observational studies in T2D during Ramadan to assess the quality of evidence and identify issues in trial design that should be addressed in future studies...
June 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Darshan A Mehta, Abiola O Oladapo, Joshua D Epstein, Aaron R Novack, Ellis J Neufeld, Joel W Hay
BACKGROUND: Hemophilia patients use factor-clotting concentrates (factor VIII for hemophilia A and factor IX for hemophilia B) for improved blood clotting. These products are used to prevent or stop bleeding episodes. However, some hemophilia patients develop inhibitors (i.e., the patient's immune system develops antibodies against these factor concentrates). Hence, these patients do not respond well to the factor concentrates. A majority of hemophilia patients with inhibitors are managed on-demand with the following bypassing agents: recombinant factor VIIa (rFVIIa) and activated prothrombin complex concentrate (aPCC)...
February 2016: Journal of Managed Care & Specialty Pharmacy
Hanne Mumm, Magda Lambaa Altinok, Jan Erik Henriksen, Pernille Ravn, Dorte Glintborg, Marianne Andersen
STUDY QUESTION: What is the prevalence of reactive hypoglycemia (RH) in polycystic ovary syndrome (PCOS) versus age- and body mass index (BMI)-matched healthy controls. SUMMARY ANSWER: The prevalence of RH was increased in PCOS versus controls. WHAT IS KNOWN ALREADY: Previous studies suggested an increased prevalence of RH in PCOS. STUDY DESIGN, SIZE, DURATION: Cross-sectional study of 88 women with PCOS and 34 healthy age- and BMI-matched controls...
May 2016: Human Reproduction
L Webber, M Davies, R Anderson, J Bartlett, D Braat, B Cartwright, R Cifkova, S de Muinck Keizer-Schrama, E Hogervorst, F Janse, L Liao, V Vlaisavljevic, C Zillikens, N Vermeulen
STUDY QUESTION: What is the optimal management of women with premature ovarian insufficiency (POI) based on the best available evidence in the literature? SUMMARY ANSWER: The guideline development group (GDG) formulated 99 recommendations answering 31 key questions on the diagnosis and treatment of women with POI. WHAT IS KNOWN ALREADY: NA. STUDY DESIGN, SIZE, DURATION: This guideline was produced by a multidisciplinary group of experts in the field using the methodology of the Manual for ESHRE Guideline Development, including a thorough systematic search of the literature, quality assessment of the included papers up to September 2014 and consensus within the guideline group on all recommendations...
May 2016: Human Reproduction
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