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Hong-Yan Cai, Zhao-Jun Wang, Christian Hölscher, Li Yuan, Jun Zhang, Peng Sun, Jing Li, Wei Yang, Mei-Na Wu, Jin-Shun Qi
Type 2 diabetes mellitus(T2DM) is a risk factor of Alzheimer's disease (AD), which is most likely linked to impairments of insulin signaling in the brain. Hence, drugs enhancing insulin signaling may have therapeutic potential for AD. Lixisenatide, a novel long-lasting glucagon-like peptide 1 (GLP-1) analogue, facilitates insulin signaling and has neuroprotective properties. We previously reported the protective effects of lixisenatide on memory formation and synaptic plasticity. Here, we describe additional key neuroprotective properties of lixisenatide and its possible molecular and cellular mechanisms against AD-related impairments in rats...
October 21, 2016: Behavioural Brain Research
Markolf Hanefeld, Denis Raccah, Louis Monnier
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease associated with hyperglycemia, which can lead to serious vascular complications. Current treatment guidelines place particular emphasis on personalization of therapy. Within this guidance, the use of various second-line therapies, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), is recommended under certain circumstances. Areas covered: Factors influencing glucose homeostasis, including gastric emptying and the associated cardiovascular (CV) risk when homeostasis is not maintained, are reviewed...
October 25, 2016: Expert Opinion on Drug Metabolism & Toxicology
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
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
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
M Mar Roca-Rodríguez, María Teresa Muros de Fuentes, Gonzalo Piédrola-Maroto, Miguel Quesada-Charneco, Silvia Maraver-Selfa, Francisco J Tinahones, Isabel Mancha-Doblas
AIM: To evaluate tolerance to lixisenatide and its effects on weight and metabolic control in type2 diabetes and obese patients. DESIGN: Prospective study. SETTING: Endocrinology clinics in Almeria, Granada and Malaga. PARTICIPANTS: Patients with type2 diabetes and obesity. INTERVENTIONS: Response and tolerance to lixisenatide treatment. MAIN MEASUREMENTS: Clinical and analytical data of the subjects were evaluated at baseline and after treatment...
September 22, 2016: Atencion Primaria
Vanita R Aroda, Julio Rosenstock, Carol Wysham, Jeffrey Unger, Diego Bellido, Guillermo González-Gálvez, Akane Takami, Hailing Guo, Elisabeth Niemoeller, Elisabeth Souhami, Richard M Bergenstal
OBJECTIVE: This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents. RESEARCH DESIGN AND METHODS: After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m(2)) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5...
September 20, 2016: Diabetes Care
Daisuke Yabe, Yutaka Seino
Incretin-based dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists are newer choices of antidiabetic medications that are now most widely used worldwide. Preclinical study results suggest that the two drugs potentially exert benefits to prevent onsets and/or progressions of diabetes-related complications, such as myocardial infarctions and strokes. Outcomes of five clinical trials to evaluate the cardiovascular (CV) safety of dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonist have been recently reported...
September 9, 2016: Journal of Diabetes Investigation
Julio Rosenstock, Ronnie Aronson, George Grunberger, Markolf Hanefeld, PierMarco Piatti, Pierre Serusclat, Xi Cheng, Tianyue Zhou, Elisabeth Niemoeller, Elisabeth Souhami, Melanie Davies
OBJECTIVE: To evaluate efficacy and safety of LixiLan (iGlarLixi), a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2 diabetes inadequately controlled on metformin with or without a second oral glucose-lowering drug. RESEARCH DESIGN AND METHODS: After a 4-week run-in to optimize metformin and stop other oral antidiabetic drugs, participants (N = 1,170, mean diabetes duration ∼8...
August 15, 2016: Diabetes Care
Angelo Avogaro, Gian Paolo Fadini, Giorgio Sesti, Enzo Bonora, Stefano Del Prato
Diabetic patients suffer from a high rate of cardiovascular events and such risk increases with HbA1c. However, lowering HbA1c does not appear to yield the same benefit on macrovascular endpoints, as observed for microvascular endpoints. As the number of glucose-lowering medications increases, clinicians have to consider several open questions in the management of type 2 diabetes, one of which is the cardiovascular risk profile of each regimen. Recent placebo-controlled cardiovascular outcome trials (CVOTs) have responded to some of these questions, but careful interpretation is needed...
2016: Cardiovascular Diabetology
R C Bonadonna, C Borghi, A Consoli, M Volpe
AIMS: Diabetes treatments aim at preventing undesirable metabolic effects of hyperglycemia and at preventing/reducing tissue damage, including cardiovascular (CV) events. For approval, novel diabetes drugs undergo early systematic investigation to assess CV safety. This review provides an updated analysis of the results of recent studies examining novel diabetes medications and CV outcomes. DATA SYNTHESIS: The new regulatory guidelines enforce adjudication of all CV events when testing novel diabetes drugs...
September 2016: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
Thomas Forst
INTRODUCTION: As type 2 diabetes mellitus (T2DM) advances, patients receiving basal insulin will eventually require another agent on top of their current regimen in order to achieve glycemic control. One such agent that can be administered in combination with basal insulin is the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide. GLP-1 RAs, such as lixisenatide, and basal insulin offer complementary mechanisms of action in their ability to provide glycemic control, thus providing a strong rationale for using them in combination with each other for the treatment of T2DM...
August 2016: Expert Opinion on Pharmacotherapy
Toru Kitazawa, Kazuhito Yokoyama, Ken Kubota
AIMS/INTRODUCTION: It is known that after pancreatectomy, patients experience hyposecretion of endogenous insulin and frequently develop diabetes. However, it has been unclear whether combination therapy with glucagon-like peptide-1 receptor agonists and basal insulin is effective for such patients. In the present study, we evaluated the efficacy and safety of combination therapy with long-acting insulin glargine and the glucagon-like peptide-1 receptor agonist lixisenatide in patients who developed diabetes after pancreatectomy...
May 2016: Journal of Diabetes Investigation
Bo Ahrén, Gagik Galstyan, Jean-Francois Gautier, Francesco Giorgino, Fernando Gomez-Peralta, Michael Krebs, Elena Nikonova, William Stager, Hernando Vargas-Uricoechea
INTRODUCTION: The extent to which postprandial glucagon reductions contribute to lowering of postprandial glucose in patients with type 2 diabetes mellitus (T2DM) is currently unknown. The aim of this analysis was to determine whether a reduction in postprandial glucagon following treatment with the glucagon-like peptide-1 receptor agonist lixisenatide correlates with a reduction in postprandial glucose and glycated hemoglobin (HbA1c) in patients with T2DM. METHODS: A post hoc analysis was performed on pooled data from the modified intent-to-treat populations of two lixisenatide Phase 3 trials: GetGoal-M (lixisenatide versus placebo as add-on to metformin) and GetGoal-S (lixisenatide versus placebo as add-on to sulfonylurea [SU] ± metformin)...
September 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Z X Li, S S Wu, Z R Yang, S Y Zhan, F Sun
OBJECTIVE: To systematically review the effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on two common respiratory system adverse events (RSAE: nasopharyngitis and upper respiratory tract infection) among type 2 diabetes (T2DM). METHODS: Medline, Embase, Clinical trials and Cochrane library were searched from inception through May 2015 to identify randomized clinical trials(RCTs) assessed safety of GLP-1RAs versus placebo or other anti-diabetic drugs in T2DM...
June 18, 2016: Beijing da Xue Xue Bao. Yi Xue Ban, Journal of Peking University. Health Sciences
Michael Nauck, Manfredi Rizzo, Andrew Johnson, Heidrun Bosch-Traberg, Jesper Madsen, Bertrand Cariou
OBJECTIVE: To compare the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in patients with type 2 diabetes not achieving adequate glycemic control on metformin alone. RESEARCH DESIGN AND METHODS: In this 26-week, randomized, parallel-group, open-label trial, 404 patients were randomized 1:1 to liraglutide 1.8 mg or lixisenatide 20 µg as add-on to metformin. Liraglutide was administered once daily at any time of the day. Lixisenatide was administered once daily within 1 h prior to the morning or evening meal...
September 2016: Diabetes Care
L H Chuang, B G Verheggen, M Charokopou, D Gibson, S Grandy, B Kartman
OBJECTIVE: To assess the cost-effectiveness of exenatide 2 mg once-weekly (EQW) compared to dulaglutide 1.5 mg QW, liraglutide 1.2 mg and 1.8 mg once-daily (QD), and lixisenatide 20 μg QD for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on metformin. METHODS: The Cardiff Diabetes Model was applied to evaluate cost-effectiveness, with treatment effects sourced from a network meta-analysis. Quality-adjusted life years (QALYs) were calculated with health-state utilities applied to T2DM-related complications, weight changes, hypoglycemia, and nausea...
June 28, 2016: Journal of Medical Economics
Julio Rosenstock, Michaela Diamant, Vanita R Aroda, Louise Silvestre, Elisabeth Souhami, Tianyue Zhou, Riccardo Perfetti, Vivian Fonseca
OBJECTIVE: This study assessed the efficacy and safety of LixiLan, a fixed-ratio, titratable, combination of 2 units insulin glargine (Gla-100) and 1 μg lixisenatide administered once daily via a single pen, versus Gla-100 in insulin-naïve type 2 diabetes on metformin. RESEARCH DESIGN AND METHODS: Participants were randomized to once-daily LixiLan (n = 161) or Gla-100 (n = 162) for 24 weeks, while continuing metformin. LixiLan and Gla-100 were started at 10 units/5 μg and 10 units, respectively, and titrated based on the Gla-100 requirement according to fasting plasma glucose levels...
September 2016: Diabetes Care
Yanwei Li, Lin Li, Christian Hölscher
Incretin hormones include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Due to their promising action on insulinotropic secretion and improving insulin resistance (IR), incretin-based therapies have become a new class of antidiabetic agents for the treatment of type 2 diabetes mellitus (T2DM). Recently, the links between neurodegenerative diseases and T2DM have been identified in a number of studies, which suggested that shared mechanisms, such as insulin dysregulation or IR, may underlie these conditions...
June 8, 2016: Reviews in the Neurosciences
Daisuke Yabe, Anu Ambos, Bertrand Cariou, Lea Duvnjak, Marc Evans, Guillermo González-Gálvez, Jay Lin, Elena V Nikonova, Pedro de Pablos-Velasco, Jean-François Yale, Bo Ahrén
AIMS: To evaluate the impact of β-cell function on the efficacy of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: In this post hoc analysis, patients from the Phase 3 GetGoal-M and GetGoal-S clinical trials randomized to lixisenatide 20μg once daily were stratified into quartiles by baseline β-cell function, as measured by the secretory units of islet in transplantation (SUIT) index...
September 2016: Journal of Diabetes and its Complications
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