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Rainer U Pliquett, Arno Noll, Richard Ibe, Alexandra Katz, Charlotte Ackmann, Alexandra Schreiber, Matthias Girndt
BACKGROUND: Here, we report a case of central pontine demyelinization in a type-2 diabetes patient with hyperglycemia after a binge-eating attack in the absence of a relevant hyponatremia. CASE PRESENTATION: A 55-year-old, male type-2 diabetic patient with liver cirrhosis stage Child-Pugh B was admitted due to dysmetria of his right arm, gait disturbance, dizziness, vertigo, and polyuria, polydipsia after a binge-eating attack of sweets (a whole fruit cake and 2 Liters of soft drinks)...
March 12, 2018: BMC Endocrine Disorders
Marco Orsini Federici, Janette McQuillan, Giovanni Biricolti, Serena Losi, Jeremie Lebrec, Catrina Richards, Cristiana Miglio, Kirsi Norrbacka
INTRODUCTION: Real-world evidence on glucagon-like peptide-1 receptor agonist (GLP-1 RAs) usage is emerging in different European countries but is lacking in Italy. This retrospective cohort study aimed to describe the real-world drug utilization patterns in patients initiating GLP-1 RAs for treating T2DM in Italy. METHODS: Adults aged ≥ 20 years and with ≥ 1 oral antidiabetic drug (alone or in combination with insulin) other than GLP-1 RAs in the 6 months prior to initiating exenatide twice daily (exBID), exenatide once weekly (exQW), dulaglutide once weekly (DULA), liraglutide once daily (LIRA) or lixisenatide once daily (LIXI) between March and July 2016 were retrospectively identified in the Italian IMS LifeLink™ longitudinal prescriptions database (retail pharmacy data)...
March 10, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
T Kimura, A Obata, M Shimoda, H Hirukawa, Y Kanda-Kimura, Y Nogami, K Kohara, S Nakanishi, T Mune, K Kaku, H Kaneto
AIMS: It is well-known that chronic exposure to large amounts of ligand leads to downregulation of its receptor. It is not known, however, whether a GLP-1R agonist downregulates its receptor. For this reason, our study examined whether GLP-1R expression is reduced after long-term exposure to dulaglutide (Dula) in non-diabetic and diabetic mice. METHODS: Seven-week-old male db/db and db/m mice were given either Dula (0.6mg/kg×2/week) or a control vehicle (CTL) for 17 weeks...
February 6, 2018: Diabetes & Metabolism
Toshinari Asakura, Shuichi Suzuki, Toshihiko Aranishi, Zhihong Cai
OBJECTIVE: This study assessed training time with the dulaglutide single-use pen (SUP) and the insulin degludec disposable prefilled pen (FlexTouch®) in self-injection-naïve patients with type 2 diabetes mellitus (T2DM) in Japan. METHODS: This multicenter, open-label, comparative, crossover study measured training time with the dulaglutide SUP versus FlexTouch® . Participants learned how to use both devices in a randomly assigned order. Healthcare providers (HCP) conducted the training...
March 5, 2018: Current Medical Research and Opinion
Bernhard Ludvik, Juan P Frías, Francisco J Tinahones, Julio Wainstein, Honghua Jiang, Kenneth E Robertson, Luis-Emilio García-Pérez, D Bradley Woodward, Zvonko Milicevic
BACKGROUND: Glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors improve glycaemic control and reduce bodyweight in patients with type 2 diabetes through different mechanisms. We assessed the safety and efficacy of the addition of the once-weekly GLP-1 receptor agonist dulaglutide to the ongoing treatment regimen in patients whose diabetes is inadequately controlled with SGLT2 inhibitors, with or without metformin. METHODS: AWARD-10 was a phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week study done at 40 clinical sites in Austria, Czech Republic, Germany, Hungary, Israel, Mexico, Spain, and the USA...
February 23, 2018: Lancet Diabetes & Endocrinology
Kevin M Pantalone, Hiren Patel, Maria Yu, Laura Fernández Landó
AIMS: To assess efficacy and safety of dulaglutide 1.5 mg combined with insulin, categorised by subgroups of baseline HbA1c (≤9% and >9%), age (<65 and ≥65 years), and duration of diabetes (<10 and ≥10 years) at 6 months in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: This pooled analysis was conducted in a similar T2D population from the AWARD-4 and AWARD-9 clinical trials randomised to dulaglutide 1.5 mg (pooled mean baseline age: 59 years, duration of diabetes: 13 years, HbA1c: 8...
February 12, 2018: Diabetes, Obesity & Metabolism
Richard E Pratley, Vanita R Aroda, Ildiko Lingvay, Jörg Lüdemann, Camilla Andreassen, Andrea Navarria, Adie Viljoen
BACKGROUND: Despite common mechanisms of actions, glucagon-like peptide-1 receptor agonists differ in structure, pharmacokinetic profile, and clinical effects. This head-to-head trial compared semaglutide with dulaglutide in patients with inadequately controlled type 2 diabetes. METHODS: This was an open-label, parallel-group, phase 3b trial done at 194 hospitals, clinical institutions or private practices in 16 countries. Eligible patients were aged 18 years or older and had type 2 diabetes with HbA1c 7·0-10·5% (53·0-91·0 mmol/mol) on metformin monotherapy...
January 31, 2018: Lancet Diabetes & Endocrinology
Paolo Pozzilli, Richard D Leslie, Anne L Peters, Raffaella Buzzetti, Sudha S Shankar, Zvonko Milicevic, Imre Pavo, Jeremie Lebrec, Sherry Martin, Nanette C Schloot
AIMS: Patients with a type-2-diabetes (T2D) phenotype positive for glutamic acid decarboxylase antibodies (GADA) represent the majority of latent autoimmune diabetes of the adult (LADA). The GLP-1 receptor agonist dulaglutide, recently introduced for treatment of T2D, has yet to be evaluated in LADA patients. Our primary objective was to evaluate the effect of dulaglutide on glycemic control (HbA1c ) in GADA-positive LADA vs. GADA-negative T2D patients. METHODS: A post-hoc analysis was performed using data from three randomized phase 3 trials (AWARD-2,-4,-5; patients with GADA assessment) which were part of the dulaglutide clinical development program in T2D...
January 27, 2018: Diabetes, Obesity & Metabolism
Takahiro Yajima, Kumiko Yajima, Makoto Hayashi, Hiroshi Takahashi, Keigo Yasuda
AIMS: To evaluate the efficacy and safety of adding once-weekly dulaglutide to insulin therapy in type 2 diabetes mellitus (T2DM) patients on hemodialysis. METHODS: Fifteen insulin-treated T2DM patients on hemodialysis were enrolled. Continuous glucose monitoring was performed before (1st hospitalization) and after the fifth dulaglutide administration (2nd hospitalization). The insulin dose was reduced after the first administration of dulaglutide (1st hospitalization day 6)...
December 21, 2017: Journal of Diabetes and its Complications
Hitoshi Ishii, Matthew Madin-Warburton, Alena Strizek, Lucy Thornton-Jones, Shuichi Suzuki
AIMS: Dulaglutide is a new once weekly glucagon-like peptide-1 (GLP-1) receptor agonist administered via a disposable auto-injection pen for the management of type 2 diabetes mellitus (T2DM). The objective of this study was to estimate the cost-effectiveness of dulaglutide vs insulin glargine for the management of T2DM from a Japanese healthcare perspective, in accordance with recently approved Japanese Cost-Effectiveness Guidelines. METHODS: The IQVIA CORE Diabetes Model (version 9) was used to estimate the long-term costs and effects of treatment with dulaglutide and insulin glargine...
February 7, 2018: Journal of Medical Economics
Caina Li, Miaomiao Yang, Xiaofeng Wang, Hua Zhang, Chenjiang Yao, Sujuan Sun, Quan Liu, Hao Pan, Shuainan Liu, Yi Huan, Shengnan Li, Jun Cao, Xing Wang, Yong Guo, Nan Guo, Shuqian Jing, Cheng Zhang, Zhufang Shen
AIMS: Glucagon like-peptide-1 (GLP-1)-based drugs have been proposed as mono- or combined therapy for type 2 diabetes mellitus. Thus we characterized a novel antibody fusion protein engineered by linking the human GLP-1 derivative to a humanized GLP-1 receptor (GLP-1R) antibody via a peptide linker. MATERIALS AND METHODS: Glutazumab was characterized by receptor binding and reporter activation assays, and its specificity was investigated with the aid of the cognate receptor antagonist exendin (9-39) and antibody Ab1...
January 17, 2018: Biochemical Pharmacology
Agostino Consoli, Gloria Formoso, Maria Pompea Antonia Baldassarre, Fabrizio Febo
Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it is more and more important to gather and discuss information about their safety profile...
March 2018: Expert Opinion on Drug Safety
Mickael Basson, Dionysios Ntais, Ruba Ayyub, Donna Wright, Julia Lowin, Florence Chartier, Stéphane Roze, Kirsi Norrbacka
INTRODUCTION: Dulaglutide is a novel onceweekly administered glucagon-like peptide 1 receptor agonist (GLP-1 RA) for the management of type 2 diabetes mellitus (T2DM). The objective of this analysis was to estimate the cost-effectiveness of dulaglutide 1.5 mg versus exenatide QW for the management of T2DM in France. METHODS: The QuintilesIMS CORE Diabetes Model was used to estimate the expected lifetime direct medical costs and outcomes of T2DM from the perspective of the French National Health Service...
November 13, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Maria Yu, Kate Van Brunt, Zvonko Milicevic, Oralee Varnado, Kristina S Boye
PURPOSE: This 28-week, randomized, double-blind study compared a once-weekly injection of dulaglutide 1.5 mg to placebo, both added to titrated once-daily insulin glargine (with or without metformin), in patients with type 2 diabetes mellitus and inadequate glycemia control (control defined as hemoglobin A1c , ≥7% and ≤10.5%). Patient-reported outcomes were assessed as an exploratory objective to further understand patients' physical, psychological, and social aspects of well-being and injection-device experience...
November 2017: Clinical Therapeutics
Emma Pace, Jeffrey Tingen
No abstract text is available yet for this article.
October 15, 2017: American Family Physician
Steve V Edelman
Since 2005, four new GLP-1RAs (liraglutide, albiglutide, dulaglutide, and lixisenatide) and a once-weekly formulation of exenatide were approved for the treatment of persons with T2DM. Another GLP-1RA, semaglutide, is under review by the FDA, as is exenatide administered via an osmotic mini-pump.
October 2017: Journal of Family Practice
Matteo Monami, Ilaria Dicembrini, Besmir Nreu, Francesco Andreozzi, Giorgio Sesti, Edoardo Mannucci
AIMS: The aim of the present meta-analysis is the identification of the characteristics of patients, which predict the efficacy on HbA1c of glucagon-like peptide-1 receptor agonists (GLP-1 RA). METHODS: A Medline and Embase search for "exenatide" OR "liraglutide" OR "albiglutide" OR "dulaglutide" OR "lixisenatide" was performed, collecting randomized clinical trials (duration > 12 weeks) up to September 2016, comparing GLP-1 RA at the maximal approved dose with placebo or active drugs...
December 2017: Acta Diabetologica
Shizuka Kaneko, Tomonori Oura, Akiko Matsui, Tomotaka Shingaki, Masakazu Takeuchi
The efficacy and safety of once-weekly dulaglutide 0.75 mg (dulaglutide) compared with once-daily insulin glargine (glargine) in Japanese patients with type 2 diabetes were evaluated according to subgroups stratified by baseline glycated hemoglobin (HbA1c) (≤8.5% or >8.5%). This exploratory analysis of a randomized, open-label, phase 3 study included 361 patients. In both HbA1c subgroups (patients with baseline HbA1c ≤8.5% or >8.5%), a statistically significantly greater reduction in HbA1c was observed in dulaglutide-treated patients compared with glargine-treated patients after 26 weeks of treatment (HbA1c ≤8...
September 14, 2017: Endocrine Journal
Sudhir Unni, Eric Wittbrodt, Junjie Ma, Marisa Schauerhamer, Jeff Hurd, Natalia Ruiz-Negrón, Carrie McAdam-Marx
A retrospective cohort study was conducted in patients with type 2 diabetes (T2D) in an electronic medical record database to compare real-world, 6-month A1C and weight outcomes for exenatide QW (EQW) vs. dulaglutide and vs. albiglutide. The study included 2,133 EQW, 201 dulaglutide, and 131 albiglutide patients. Overall mean (SD) age was 60 (11) years and 54% were men; neither differed between comparison groups. Mean baseline A1C was similar for EQW [8.3 (1.7)%] and dulaglutide [8.5 (1.5)% (p=0.165)], but higher for albiglutide [8...
September 1, 2017: Diabetes, Obesity & Metabolism
Baptist Gallwitz, Samuel Dagogo-Jack, Vivian Thieu, Luis-Emilio Garcia-Perez, Imre Pavo, Maria Yu, Kenneth E Robertson, Nan Zhang, Francesco Giorgino
To evaluate the efficacy and safety of dulaglutide 1.5 mg and 0.75 mg in type 2 diabetes patients by subgroups of gender, duration of diabetes, and baseline HbA1c in the dulaglutide clinical development program (AWARD-1 to -6 and -8 clinical trials). MATERIALS AND METHODS: Change in HbA1c was analysed by gender, duration of diabetes (<5 years, ≥5 years and <10 years, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia, and gastrointestinal adverse events were evaluated for individual trials...
August 17, 2017: Diabetes, Obesity & Metabolism
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