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Author Vanita R Aroda

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EMPA-REG OUTCOME and beyond: the long game of cardiovascular risk reduction.

Vanita R Aroda, Marc S Sabatine,

Lancet Diabetes Endocrinol (The lancet. Diabetes & endocrinology)
[2020, 8(12):932-933]

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Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses.

Richard E Pratley, Vanita R Aroda, Andrei-Mircea Catarig, Ildiko Lingvay, Jörg Lüdemann, Emre Yildirim, Adie Viljoen,

OBJECTIVE:In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide. DESIGN:Analyses by baseline age (<65, ≥65 ... Read more >>

BMJ Open (BMJ open)
[2020, 10(11):e037883]

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Gastrointestinal adverse events with insulin glargine/lixisenatide fixed-ratio combination versus glucagon-like peptide-1 receptor agonists in people with type 2 diabetes mellitus: A network meta-analysis.

Christopher K Rayner, Tongzhi Wu, Vanita R Aroda, Craig Whittington, Steve Kanters, Patricia Guyot, Alka Shaunik, Michael Horowitz,

AIMS:Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are the recommended first injectable therapy in type 2 diabetes. However, long-term persistence is suboptimal and partly attributable to gastrointestinal tolerability, particularly during initiation/escalation. Gradual titration of fixed-ratio combination GLP-1 RA/insulin therapies may improve GLP-1 RA gastrointestinal tolerability. We compared gastrointestinal adverse event (AE) ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, :]

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Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.

Eugene E Wright, Vanita R Aroda,

Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data ... Read more >>

Postgrad Med (Postgraduate medicine)
[2020, 132(sup2):26-36]

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Use of Glucagon-Like Peptide-1 Receptor Agonists in Patients With Type 2 Diabetes and Cardiovascular Disease: A Review.

Michael C Honigberg, Lee-Shing Chang, Darren K McGuire, Jorge Plutzky, Vanita R Aroda, Muthiah Vaduganathan,

Importance:Recent randomized clinical trials have demonstrated that glucagon-like peptide-1 receptor agonists (GLP-1RAs) reduce cardiovascular events in at-risk individuals with type 2 diabetes. Despite these findings, GLP-1RAs are underused in eligible patients, particularly by cardiologists. Observations:To date, randomized clinical trials of albiglutide, dulaglutide, liraglutide, and injectable semaglutide have reported favorable cardiovascular ... Read more >>

JAMA Cardiol (JAMA cardiology)
[2020, :]

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Efficacy and safety of iGlarLixi versus IDegLira in adults with type 2 diabetes inadequately controlled by glucagon-like peptide-1 receptor agonists: a systematic literature review and indirect treatment comparison.

Philip D Home, Vanita R Aroda, Lawrence Blonde, Patricia Guyot, Alka Shaunik, Mir Sohail Fazeli, Hardik Goswami, Sanjay Kalra, Mir-Masoud Pourrahmat,

AIMS:To estimate the relative treatment effect between the fixed-ratio combinations iGlarLixi and IDegLira (glucagon-like peptide 1 receptor agonist with basal insulin) in people with type 2 diabetes inadequately controlled on a glucagon-like peptide 1 receptor agonist. MATERIALS AND METHODS:A systematic literature review of randomized controlled trials followed by an indirect ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, :]

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Adults with early-onset type 2 diabetes (aged 18-39 years) are severely underrepresented in diabetes clinical research trials.

Jack A Sargeant, Emer M Brady, Francesco Zaccardi, Frances Tippins, David R Webb, Vanita R Aroda, Edward W Gregg, Kamlesh Khunti, Melanie J Davies,

AIMS/HYPOTHESIS:Early-onset adult type 2 diabetes (diagnosed between ages 18 and 39 years) is increasingly prevalent and associated with poor long-term outcomes. We hypothesised that individuals with early-onset adult type 2 diabetes were underrepresented in the prominent research trials that underpin type 2 diabetes management guidelines. METHODS:We reviewed the mean age of ... Read more >>

Diabetologia (Diabetologia)
[2020, 63(8):1516-1520]

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Impact of disease duration and β-cell reserve on the efficacy of switching to iGlarLixi in adults with type 2 diabetes on glucagon-like peptide-1 receptor agonist therapy: Exploratory analyses from the LixiLan-G trial.

Stefano Del Prato, Juan Pablo Frias, Lawrence Blonde, Vanita R Aroda, Niam Shehadeh, Aramesh Saremi, Terry Dex, Elisabeth Niemoeller, Elisabeth Souhami, Minzhi Liu, Julio Rosenstock,

AIM:To evaluate the efficacy of iGlarLixi by C-peptide levels and duration of diabetes in an exploratory analysis of the LixiLan-G study. METHODS:LixiLan-G was a 26-week, randomized, open-label study in adults with type diabetes (T2D) inadequately controlled while on a glucagon-like peptide-1 receptor agonist (GLP-1 RA), with metformin, with or without ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(9):1567-1576]

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iGlarLixi effectively reduces residual hyperglycaemia in patients with type 2 diabetes on basal insulin: A post hoc analysis from the LixiLan-L study.

Nicola Morea, Ravi Retnakaran, Josep Vidal, Vanita R Aroda, Minzhi Liu, Aramesh Saremi, Francesco Giorgino,

Globally, nearly half of patients with type 2 diabetes (T2D) do not successfully achieve target HbA1c with basal insulin, despite meeting fasting plasma glucose (FPG) targets. In this post hoc analysis of the LixiLan-L study, we determined whether iGlarLixi, a fixed-ratio combination of insulin glargine Gla-100 (iGlar) and the glucagon-like ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(9):1683-1689]

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Optimization of Metformin in the GRADE Cohort: Effect on Glycemia and Body Weight.

William I Sivitz, Lawrence S Phillips, Deborah J Wexler, Stephen P Fortmann, Anne W Camp, Margaret Tiktin, Magalys Perez, Jacqueline Craig, Priscilla A Hollander, Andrea Cherrington, Vanita R Aroda, Meng Hee Tan, Jonathan Krakoff, Neda Rasouli, Nicole M Butera, Naji Younes, ,

OBJECTIVE:We evaluated the effect of optimizing metformin dosing on glycemia and body weight in type 2 diabetes. RESEARCH DESIGN AND METHODS:This was a prespecified analysis of 6,823 participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) taking metformin as the sole glucose-lowering drug who completed a ... Read more >>

Diabetes Care (Diabetes care)
[2020, 43(5):940-947]

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Fixed-Ratio Combination of Insulin and GLP-1 RA in Patients with Longstanding Type 2 Diabetes: A Subanalysis of LixiLan-L.

Lawrence Blonde, Lori Berard, Aramesh Saremi, Yao Huang, Vanita R Aroda, Denis Raccah,

INTRODUCTION:With longer duration and progression of type 2 diabetes (T2D), β-cell function deteriorates and insulin therapy often becomes necessary. Glucagon-like peptide-1 receptor agonists such as lixisenatide that do not rely only on β-cell function and glucagon suppression primarily, but also lower glucose by other (insulin-independent) mechanisms such as delayed gastric ... Read more >>

Diabetes Ther (Diabetes therapy : research, treatment and education of diabetes and related disorders)
[2020, 11(4):1007-1015]

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Reproducibility of a prediabetes classification in a contemporary population.

Chhavi Chadha, Anastassios G Pittas, Christine W Lary, William C Knowler, Ranee Chatterjee, Lawrence S Phillips, Vanita R Aroda, Michael R Lewis, Richard Pratley, Myrlene A Staten, Jason Nelson, Neda Rasouli, Irwin Brodsky, ,

Aims:To assess whether meeting both fasting plasma glucose (FPG) and HbA1c criteria for prediabetes in people at high risk indicates with near certainty the presence of dysglycemia on repeat testing. Methods:Observational study using data from Vitamin D and Type 2 Diabetes (D2d) study. HbA1c, FPG were measured at screening visit ... Read more >>

Metabol Open (Metabolism open)
[2020, 6:100031]

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Implications of the Hemoglobin Glycation Index on the Diagnosis of Prediabetes and Diabetes.

Daniel S Hsia, Neda Rasouli, Anastassios G Pittas, Christine W Lary, Anne Peters, Michael R Lewis, Sangeeta R Kashyap, Karen C Johnson, Erin S LeBlanc, Lawrence S Phillips, James M Hempe, Cyrus V Desouza, ,

OBJECTIVE:Fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG) from a 75-g oral glucose tolerance test (OGTT) and glycated hemoglobin (HbA1c) can lead to different results when diagnosing prediabetes and diabetes. The Hemoglobin Glycation Index (HGI) quantifies the interindividual variation in glycation resulting in discrepancies between FPG and HbA1c. We used ... Read more >>

J Clin Endocrinol Metab (The Journal of clinical endocrinology and metabolism)
[2020, 105(3):]

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A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice.

Giorgio Sesti, Lars Bardtrum, Selcuk Dagdelen, Natalie Halladin, Martin Haluzík, Petra Őrsy, Martin Rodríguez, Vanita R Aroda,

This report presents the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as initial injectable therapy at 26 weeks in the 104-week DUAL VIII durability trial (NCT02501161). Participants (N = 1012) with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs) were randomized 1:1 to ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(5):873-878]

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Bridging the Gap for Patients with Diabetes and Cardiovascular Disease Through Cardiometabolic Collaboration.

Lee-Shing Chang, Muthiah Vaduganathan, Jorge Plutzky, Vanita R Aroda,

PURPOSE OF REVIEW:Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in individuals with type 2 diabetes (T2D). Recent cardiovascular outcome trials (CVOTs) have established sodium-glucose co-transporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1 RA) as powerful medications that can lower glucose as well as reduce the ... Read more >>

Curr Diab Rep (Current diabetes reports)
[2019, 19(12):157]

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Impact of baseline characteristics and beta-cell function on the efficacy and safety of subcutaneous once-weekly semaglutide: A patient-level, pooled analysis of the SUSTAIN 1-5 trials.

Vanita R Aroda, Matthew S Capehorn, Louis Chaykin, Juan P Frias, Nanna L Lausvig, Stanislava Macura, Jörg Lüdemann, Sten Madsbad, Julio Rosenstock, Omur Tabak, Sayeh Tadayon, Stephen C Bain,

AIM:To evaluate the impact of relevant patient-level characteristics on the efficacy and safety of subcutaneous, once-weekly semaglutide in subjects with type 2 diabetes. MATERIALS AND METHODS:Exploratory post hoc analyses of pooled SUSTAIN 1-5 (phase 3a) randomized, controlled trials examined the change from baseline in HbA1c and body weight (BW), and ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2020, 22(3):303-314]

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Erratum. Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. Diabetes Care 2018;41:1590-1599.

Erin S LeBlanc, Richard E Pratley, Bess Dawson-Hughes, Myrlene A Staten, Patricia R Sheehan, Michael R Lewis, Anne Peters, Sun H Kim, Ranee Chatterjee, Vanita R Aroda, Chhavi Chadha, Lisa M Neff, Irwin G Brodsky, Clifford Rosen, Cyrus V Desouza, John P Foreyt, Daniel S Hsia, Karen C Johnson, Philip Raskin, Sangeeta R Kashyap, Patrick O'Neil, Lawrence S Phillips, Neda Rasouli, Emilia P Liao, David C Robbins, Anastassios G Pittas, ,

Diabetes Care (Diabetes care)
[2019, 42(12):2347]

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Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.

Bernard Zinman, Vanita R Aroda, John B Buse, Bertrand Cariou, Stewart B Harris, Søren Tetens Hoff, Karen Boje Pedersen, Mads Jeppe Tarp-Johansen, Eiichi Araki, ,

OBJECTIVE:To investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin. RESEARCH DESIGN AND METHODS:Patients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide 3 mg (N = 184), 7 mg (N = 182), or 14 mg ... Read more >>

Diabetes Care (Diabetes care)
[2019, 42(12):2262-2271]

Cited: 3 times

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Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.

Lawrence Blonde, Julio Rosenstock, Stefano Del Prato, Robert Henry, Naim Shehadeh, Juan Frias, Elisabeth Niemoeller, Elisabeth Souhami, Chen Ji, Vanita R Aroda,

OBJECTIVE:Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or ... Read more >>

Diabetes Care (Diabetes care)
[2019, 42(11):2108-2116]

Cited: 1 time

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Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial.

Lawrence Blonde, Timothy S Bailey, Jason Chao, Terry A Dex, Juan Pablo Frias, Luigi F Meneghini, Michelle Roberts, Vanita R Aroda,

INTRODUCTION:iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and safety outcomes in participants who ... Read more >>

Adv Ther (Advances in therapy)
[2019, 36(9):2310-2326]

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Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Deborah J Wexler, Heidi Krause-Steinrauf, Jill P Crandall, Hermes J Florez, Sophia H Hox, Alexander Kuhn, Ajay Sood, Chantal Underkofler, Vanita R Aroda, ,

OBJECTIVE:GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey ... Read more >>

Diabetes Care (Diabetes care)
[2019, 42(11):2098-2107]

Cited: 1 time

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Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example.

Vanita R Aroda, Trine Saugstrup, John B Buse, Morten Donsmark, Jeppe Zacho, Melanie J Davies,

Regulatory guidelines describe the use of estimands in designing and conducting clinical trials. Estimands ensure alignment of the objectives with the design, conduct and analysis of a trial. An estimand is defined by four inter-related attributes: the population of interest, the variable (endpoint) of interest, the way intercurrent events are ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2019, 21(10):2203-2210]

Cited: 6 times

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Vitamin D Supplementation and Prevention of Type 2 Diabetes.

Anastassios G Pittas, Bess Dawson-Hughes, Patricia Sheehan, James H Ware, William C Knowler, Vanita R Aroda, Irwin Brodsky, Lisa Ceglia, Chhavi Chadha, Ranee Chatterjee, Cyrus Desouza, Rowena Dolor, John Foreyt, Paul Fuss, Adline Ghazi, Daniel S Hsia, Karen C Johnson, Sangeeta R Kashyap, Sun Kim, Erin S LeBlanc, Michael R Lewis, Emilia Liao, Lisa M Neff, Jason Nelson, Patrick O'Neil, Jean Park, Anne Peters, Lawrence S Phillips, Richard Pratley, Philip Raskin, Neda Rasouli, David Robbins, Clifford Rosen, Ellen M Vickery, Myrlene Staten, ,

BACKGROUND:Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown. METHODS:We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, ... Read more >>

N Engl J Med (The New England journal of medicine)
[2019, 381(6):520-530]

Cited: 42 times

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Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.

Vanita R Aroda, Guillermo González-Galvez, Randi Grøn, Natalie Halladin, Martin Haluzík, György Jermendy, Adri Kok, Petra Őrsy, Mohamed Sabbah, Giorgio Sesti, Robert Silver,

BACKGROUND:Durability of glycaemic control might reduce disease burden and improve long-term outcomes. DUAL VIII investigated the durability of insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes with the use of a visit schedule that mirrored routine clinical practice. METHODS:In this ... Read more >>

Lancet Diabetes Endocrinol (The lancet. Diabetes & endocrinology)
[2019, 7(8):596-605]

Cited: 4 times

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PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes.

Vanita R Aroda, Julio Rosenstock, Yasuo Terauchi, Yuksel Altuntas, Nebojsa M Lalic, Enrique C Morales Villegas, Ole K Jeppesen, Erik Christiansen, Christin L Hertz, Martin Haluzík, ,

OBJECTIVE:This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, as monotherapy with placebo in patients with type 2 diabetes managed by diet and exercise alone. Two estimands addressed two efficacy-related questions: a treatment policy estimand (regardless of trial product discontinuation ... Read more >>

Diabetes Care (Diabetes care)
[2019, 42(9):1724-1732]

Cited: 10 times

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