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Article ; Online: Effect of expanded dulaglutide weekly doses (3.0 mg and 4.5 mg) on cardiovascular disease risk factors in participants with type 2 diabetes at increased cardiovascular disease risk: a post hoc analysis of the AWARD-11 study.

Cox, David A / Wang, Hui / Nicolay, Claudia / Bethel, Mary Angelyn

2022 Volume 24, Issue 9, Page(s) 1770–1778

Abstract: Aims: This post hoc analysis investigated the effect of dulaglutide on cardiovascular disease (CVD) risk factors in subgroups of participants at increased CVD risk in the AWARD-11 study.: Methods: Participants who received once weekly dulaglutide 1.5, ...

Abstract	Aims: This post hoc analysis investigated the effect of dulaglutide on cardiovascular disease (CVD) risk factors in subgroups of participants at increased CVD risk in the AWARD-11 study. Methods: Participants who received once weekly dulaglutide 1.5, 3.0 or 4.5 mg for 52 weeks were categorized according to their baseline Framingham CVD risk category [low (N = 295), medium (N = 481) and high (N = 1054) risk], as well as their baseline CVD risk according to the REWIND study eligibility criteria (N = 953). Serum lipids and vital signs were assessed at baseline and at 52 weeks. Data were analysed as least squares mean percentage change from baseline for lipids and least squares mean change from baseline for vital signs. Results: Demographic and baseline clinical characteristics were balanced across doses within the CVD risk groups. In the high Framingham CVD risk and REWIND-like groups, dulaglutide resulted in dose-related decreases in total cholesterol (≤6.0%), non-high-density lipoprotein cholesterol (≤8.8%), very-low-density lipoprotein cholesterol (≤19.4%) and triglycerides (≤21.5%), with little change in low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Systolic and diastolic blood pressure decreased up to 5.6 mmHg and 1.6 mmHg, respectively, and heart rate increased up to 2 beats/min. Conclusions: This post hoc analysis suggests the magnitude of the favourable effects of dulaglutide 3.0 mg and 4.5 mg on several cardiometabolic CVD risk factors was similar to, if not greater than, those of dulaglutide 1.5 mg among participants with type 2 diabetes and increased CVD risk. Clinicaltrials: gov Identifier: NCT03495102.
MeSH term(s)	Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/prevention & control ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Glucagon-Like Peptides/adverse effects ; Glucagon-Like Peptides/analogs & derivatives ; Humans ; Hypoglycemic Agents/adverse effects ; Immunoglobulin Fc Fragments/adverse effects ; Lipids ; Recombinant Fusion Proteins/adverse effects ; Risk Factors
Chemical Substances	Hypoglycemic Agents ; Immunoglobulin Fc Fragments ; Lipids ; Recombinant Fusion Proteins ; Glucagon-Like Peptides (62340-29-8) ; dulaglutide (WTT295HSY5)
Language	English
Publishing date	2022-05-29
Publishing country	England
Document type	Clinical Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14762
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Article: A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities.

Currie, Brooke M / Howell, Timothy A / Matza, Louis S / Cox, David A / Johnston, Joseph A

Diabetes therapy : research, treatment and education of diabetes and related disorders

2021 Volume 12, Issue 11, Page(s) 2827–2856

Abstract: Introduction: In recent decades, the dramatic rise of obesity among youth in the US has been accompanied by a rise in the prevalence of type 2 diabetes (T2D) in this population. This alarming trend underscores the importance of conducting trials to ... ...

Abstract	Introduction: In recent decades, the dramatic rise of obesity among youth in the US has been accompanied by a rise in the prevalence of type 2 diabetes (T2D) in this population. This alarming trend underscores the importance of conducting trials to evaluate new therapies in children with T2D. Methods: A targeted review of peer-reviewed literature and trials registered on www.clinicaltrials.gov was conducted in January 2021 to identify pharmaceutical interventional studies in youth with T2D. Information regarding enrollment data, study design elements, subjects' baseline characteristics, and key treatment outcomes was documented. Results: Among the 16 clinical studies included in this review, only five appeared to meet projected enrollment targets in < 4 years. Although three other studies met recruitment targets, two took approximately 5 years to complete and the third took nearly 10 years. Conclusions: Despite legislation requiring evaluation of pharmaceutical treatments in pediatric populations, surprisingly few interventional studies have been conducted in children with T2D. This review highlights that recruitment challenges may be impeding the conduct and completion of interventional studies. Consequently, few pharmaceutical treatments have been proven to be effective and approved for children with T2D. Metformin and liraglutide remain the only non-insulin treatments formally approved in the US for use in this population. More clinical research is needed to support regulatory decision-making as well as treatment decisions for children with T2D in clinical settings. Sponsors and investigators will need to implement strategies for improving trial enrollment as well as work with regulatory agencies to develop novel study designs that may require fewer patients.
Language	English
Publishing date	2021-09-23
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2566702-6
ISSN	1869-6961 ; 1869-6953
ISSN (online)	1869-6961
ISSN	1869-6953
DOI	10.1007/s13300-021-01136-5
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: What Should I Do?: Maintenance of Certification for All Cardiologists in 2019 and Beyond.

Valentine, C Michael / Cox, David A / Deering, Thomas F / Starling, Randall C

Journal of the American College of Cardiology

2019 Volume 73, Issue 4, Page(s) 517–520

MeSH term(s)	Cardiology ; Certification
Language	English
Publishing date	2019-01-31
Publishing country	United States
Document type	Editorial
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2018.12.024
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Article ; Online: Glycaemic efficacy of an expanded dose range of dulaglutide according to baseline glycated haemoglobin (HbA1c) subgroup: Post hoc analysis of AWARD-11.

Frias, Juan P / Bonora, Enzo / Cox, David A / Bethel, M Angelyn / Kwan, Anita Y M / Raha, Sohini / Malik, Raleigh E

Diabetes, obesity & metabolism

2021 Volume 23, Issue 12, Page(s) 2819–2824

Abstract: The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. This post hoc analysis examined the change from baseline in ... ...

Abstract	The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide 3.0 and 4.5 mg compared to dulaglutide 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. This post hoc analysis examined the change from baseline in glycated haemoglobin (HbA1c) and proportions of patients achieving HbA1c <7% at weeks 36 and 52 with dulaglutide 1.5 mg, 3.0 mg or 4.5 mg across clinically relevant baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%). Mean reductions in HbA1c were observed across all baseline HbA1c subgroups at 36 weeks (range of HbA1c change: 1.5 mg: -1.0% to -2.2%; 3.0 mg: -1.2% to -2.5%; and 4.5 mg: -1.2% to -3.2%). More patients randomized to 3.0 mg or 4.5 mg (vs. 1.5 mg) achieved HbA1c <7% at 36 weeks regardless of baseline HbA1c; the difference in proportions was greater at higher baseline HbA1c (P-interaction = 0.096). Similar patterns in glycaemic improvement and proportions achieving HbA1c <7% were observed at 52 weeks. Hypoglycaemia and gastrointestinal adverse events were similar among the HbA1c subgroups. Glycaemic control was improved with dulaglutide dose escalation from 1.5 mg to 3.0 mg or 4.5 mg across baseline HbA1c subgroups (<8%; 8.0% to < 9.0%; 9.0% to < 10%; and ≥ 10%).
MeSH term(s)	Diabetes Mellitus, Type 2/drug therapy ; Glucagon-Like Peptides/adverse effects ; Glucagon-Like Peptides/analogs & derivatives ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/adverse effects ; Immunoglobulin Fc Fragments/adverse effects ; Recombinant Fusion Proteins ; Treatment Outcome
Chemical Substances	Glycated Hemoglobin A ; Hypoglycemic Agents ; Immunoglobulin Fc Fragments ; Recombinant Fusion Proteins ; Glucagon-Like Peptides (62340-29-8) ; dulaglutide (WTT295HSY5)
Language	English
Publishing date	2021-09-14
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14533
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Article ; Online: Endovascular repair of ruptured pseudoaneurysm of left internal mammary graft following redo aortic valve replacement and coronary artery bypass grafting.

Nair, Sanjeev U / Patel, Nainesh C / Cox, David A

JACC. Cardiovascular interventions

2015 Volume 8, Issue 1 Pt A, Page(s) e3–5

MeSH term(s)	Aneurysm, False/diagnosis ; Aneurysm, False/etiology ; Aneurysm, False/therapy ; Aneurysm, Ruptured/diagnosis ; Aneurysm, Ruptured/etiology ; Aneurysm, Ruptured/therapy ; Angioplasty, Balloon, Coronary/instrumentation ; Aortic Valve/surgery ; Coronary Angiography ; Heart Valve Prosthesis Implantation/adverse effects ; Humans ; Internal Mammary-Coronary Artery Anastomosis/adverse effects ; Male ; Mammary Arteries/diagnostic imaging ; Mammary Arteries/surgery ; Middle Aged ; Reoperation ; Stents ; Treatment Outcome
Language	English
Publishing date	2015-01
Publishing country	United States
Document type	Case Reports ; Journal Article ; Video-Audio Media
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2014.08.008
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Zs.A 6669: Show issues

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Book ; Online: Ideals, Varieties, and Algorithms

Cox, David A / Little, John / O'Shea, Donal

An Introduction to Computational Algebraic Geometry and Commutative Algebra

(Undergraduate Texts in Mathematics)

2015

Abstract: This text covers topics in algebraic geometry and commutative algebra with a strong perspective toward practical and computational aspects. The first four chapters form the core of the book. A comprehensive chart in the preface illustrates a variety of ... ...

Author's details	by David A. Cox, John Little, Donal O'Shea
Series title	Undergraduate Texts in Mathematics
Abstract	This text covers topics in algebraic geometry and commutative algebra with a strong perspective toward practical and computational aspects. The first four chapters form the core of the book. A comprehensive chart in the preface illustrates a variety of ways to proceed with the material once these chapters are covered. In addition to the fundamentals of algebraic geometry-the elimination theorem, the extension theorem, the closure theorem, and the Nullstellensatz-this new edition incorporates several substantial changes, all of which are listed in the Preface. The largest revision incorporates a new chapter (ten), which presents some of the essentials of progress made over the last decades in computing Gröbner bases. The book also includes current computer algebra material in Appendix C and updated independent projects (Appendix D). The book may serve as a first or second course in undergraduate abstract algebra and, with some supplementation perhaps, for beginning graduate level courses in algebraic geometry or computational algebra. Prerequisites for the reader include linear algebra and a proof-oriented course. It is assumed that the reader has access to a computer algebra system. Appendix C describes features of Maple™, Mathematica®, and Sage, as well as other systems that are most relevant to the text. Pseudocode is used in the text; Appendix B carefully describes the pseudocode used. From the reviews of previous editions: “…The book gives an introduction to Buchberger’s algorithm with applications to syzygies, Hilbert polynomials, primary decompositions. There is an introduction to classical algebraic geometry with applications to the ideal membership problem, solving polynomial equations, and elimination theory. …The book is well-written. …The reviewer is sure that it will be an excellent guide to introduce further undergraduates in the algorithmic aspect of commutative algebra and algebraic geometry.” -Peter Schenzel, zbMATH, 2007 “I consider the book to be wonderful. .. The exposition is very clear, there are many helpful pictures, and there are a great many instructive exercises, some quite challenging .. offers the heart and soul of modern commutative and algebraic geometry.” -The American Mathematical Monthly
Keywords	Algebra ; Computer software ; Geometry, algebraic ; Logic, Symbolic and mathematical ; Mathematics
Language	English
Size	Online-Ressource (XVI, 646 p. 95 illus., 10 illus. in color), online resource
Edition	4th ed. 2015
Publisher	Springer International Publishing
Publishing place	Cham ;s.l
Document type	Book ; Online
ISBN	9783319167206 ; 9783319167213 ; 3319167200 ; 3319167219
DOI	10.1007/978-3-319-16721-3
Database	Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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Article ; Conference proceedings: Higher doses of dulaglutide induce weight loss in patients with type 2 diabetes (T2D) regardless of baseline BMI: post hoc analysis of AWARD-11

Bonora, Enzo / Frias, Juan / Malik, Raleigh / Kwan, Anita / Raha, Sohini / Bethel, Angelyn / Cox, David A. / Blüher, Matthias

Diabetologie und Stoffwechsel

2022 Volume 17, Issue S 01

Event/congress	Diabetes Kongress 2022 - 56. Jahrestagung der DDG, CityCube Berlin, 2022-05-25
Language	English
Publishing date	2022-05-01
Publisher	Georg Thieme Verlag KG
Publishing place	Stuttgart ; New York
Document type	Article ; Conference proceedings
ZDB-ID	2222993-0
ISSN	1861-9010 ; 1861-9002
ISSN (online)	1861-9010
ISSN	1861-9002
DOI	10.1055/s-0042-1746329
Database	Thieme publisher's database

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Article ; Online: Efficacy and safety of dulaglutide 3.0 and 4.5 mg in patients aged younger than 65 and 65 years or older: Post hoc analysis of the AWARD-11 trial.

Frias, Juan P / Bonora, Enzo / Nevárez Ruiz, Luis / Hsia, Stanley H / Jung, Heike / Raha, Sohini / Cox, David A / Bethel, M Angelyn / Konig, Manige

Diabetes, obesity & metabolism

2021 Volume 23, Issue 10, Page(s) 2279–2288

Abstract: Aim: To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years).: Materials and methods: Of 1842 patients included in this post hoc analysis, 438 ...

Abstract	Aim: To evaluate the efficacy and safety of dulaglutide 3.0 and 4.5 mg versus 1.5 mg when used as an add-on to metformin in subgroups defined by age (<65 and ≥65 years). Materials and methods: Of 1842 patients included in this post hoc analysis, 438 were aged 65 years or older and 1404 were younger than 65 years. The intent-to-treat (ITT) population, while on treatment without rescue medication, was used for all efficacy analyses; the ITT population without rescue medication was used for hypoglycaemia analyses; all other safety analyses used the ITT population. Results: Patients aged 65 years or older and those younger than 65 years had a mean age of 69.5 and 53.2 years, respectively. In each age subgroup, the reduction from baseline in HbA1c and body weight (BW), and the proportion of patients achieving a composite endpoint of HbA1c of less than 7% (<53 mmol/mol) with no weight gain and no documented symptomatic or severe hypoglycaemia, were larger for dulaglutide 3.0 and 4.5 mg compared with dulaglutide 1.5 mg, but the treatment-by-age interactions were not significant. The safety profile for the additional dulaglutide doses was consistent with that of dulaglutide 1.5 mg and was similar between the age subgroups. Conclusion: Dulaglutide doses of 3.0 or 4.5 mg provided clinically relevant, dose-related improvements in HbA1c and BW with no significant treatment-by-age interactions, and with a similar safety profile across age subgroups.
MeSH term(s)	Aged ; Diabetes Mellitus, Type 2/drug therapy ; Glucagon-Like Peptides/adverse effects ; Glucagon-Like Peptides/analogs & derivatives ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/adverse effects ; Immunoglobulin Fc Fragments/adverse effects ; Middle Aged ; Recombinant Fusion Proteins ; Treatment Outcome
Chemical Substances	Glycated Hemoglobin A ; Hypoglycemic Agents ; Immunoglobulin Fc Fragments ; Recombinant Fusion Proteins ; Glucagon-Like Peptides (62340-29-8) ; dulaglutide (WTT295HSY5)
Language	English
Publishing date	2021-07-08
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14469
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Article ; Online: Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11).

Frias, Juan P / Bonora, Enzo / Nevarez Ruiz, Luis / Li, Ying G / Yu, Zhuoxin / Milicevic, Zvonko / Malik, Raleigh / Bethel, M Angelyn / Cox, David A

Diabetes care

2021 Volume 44, Issue 3, Page(s) 765–773

Abstract: Objective: To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin.: Research design and methods: Patients were randomly assigned to once-weekly ... ...

Abstract	Objective: To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. Research design and methods: Patients were randomly assigned to once-weekly dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg for 52 weeks. The primary objective was determining superiority of dulaglutide 3.0 mg and/or 4.5 mg over 1.5 mg in HbA Results: Mean baseline HbA Conclusions: In patients with type 2 diabetes inadequately controlled by metformin, escalation from dulaglutide 1.5 mg to 3.0 mg or 4.5 mg provided clinically relevant, dose-related reductions in HbA
MeSH term(s)	Diabetes Mellitus, Type 2/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Glucagon-Like Peptides/adverse effects ; Glucagon-Like Peptides/analogs & derivatives ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/adverse effects ; Immunoglobulin Fc Fragments/adverse effects ; Metformin/adverse effects ; Recombinant Fusion Proteins ; Treatment Outcome
Chemical Substances	Glycated Hemoglobin A ; Hypoglycemic Agents ; Immunoglobulin Fc Fragments ; Recombinant Fusion Proteins ; Glucagon-Like Peptides (62340-29-8) ; Metformin (9100L32L2N) ; dulaglutide (WTT295HSY5)
Language	English
Publishing date	2021-01-04
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc20-1473
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Article ; Online: Effect of dulaglutide 3.0 and 4.5 mg on weight in patients with type 2 diabetes: Exploratory analyses of AWARD-11.

Bonora, Enzo / Frias, Juan P / Tinahones, Francisco J / Van, Joanna / Malik, Raleigh E / Yu, Zhuoxin / Mody, Reema / Bethel, Angelyn / Kwan, Anita Y M / Cox, David A

Diabetes, obesity & metabolism

2021 Volume 23, Issue 10, Page(s) 2242–2250

Abstract: Aim: To evaluate the impact of dulaglutide 3.0 and 4.5 mg versus 1.5 mg on body weight in patients with type 2 diabetes (T2D) based on exploratory analyses of the AWARD-11 trial.: Materials and methods: Patients were randomized to once-weekly ... ...

Abstract	Aim: To evaluate the impact of dulaglutide 3.0 and 4.5 mg versus 1.5 mg on body weight in patients with type 2 diabetes (T2D) based on exploratory analyses of the AWARD-11 trial. Materials and methods: Patients were randomized to once-weekly dulaglutide 1.5 (n = 612), 3.0 (n = 616) or 4.5 mg (n = 614) for 52 weeks. The primary objective was superiority of dulaglutide 3.0 and/or 4.5 mg over 1.5 mg in HbA1c reduction at 36 weeks. Secondary and exploratory assessments included weight reduction in the overall trial population and baseline body mass index (BMI) and HbA1c subgroups. Results: At baseline, patients had a mean age of 57.1 years, HbA1c 8.6% (70 mmol/mol), weight 95.7 kg and BMI 34.2 kg/m Conclusions: In patients with T2D, inadequately controlled by metformin, incremental weight loss was observed with dulaglutide 1.5, 3.0 and 4.5 mg doses regardless of baseline BMI or HbA1c. Although absolute weight loss was numerically greater in patients with higher baseline BMI, percentage of weight loss was similar between BMI subgroups.
MeSH term(s)	Diabetes Mellitus, Type 2/drug therapy ; Glucagon-Like Peptides/adverse effects ; Glucagon-Like Peptides/analogs & derivatives ; Glycated Hemoglobin A/analysis ; Humans ; Hypoglycemic Agents/adverse effects ; Immunoglobulin Fc Fragments/adverse effects ; Middle Aged ; Recombinant Fusion Proteins
Chemical Substances	Glycated Hemoglobin A ; Hypoglycemic Agents ; Immunoglobulin Fc Fragments ; Recombinant Fusion Proteins ; Glucagon-Like Peptides (62340-29-8) ; dulaglutide (WTT295HSY5)
Language	English
Publishing date	2021-06-29
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14465
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