Are current clinical trials in diabetes addressing important issues in diabetes care?

WC Lakey, K Barnard, BC Batch, K Chiswell… - Diabetologia, 2013 - Springer
Aims/hypothesis Clinical trials assessing interventions for treating and preventing diabetes
mellitus and its complications are needed to inform evidence-based practice. To examine …

Patient-important outcomes in registered diabetes trials

GY Gandhi, MH Murad, A Fujiyoshi, RJ Mullan… - Jama, 2008 - jamanetwork.com
Context Concerns about the safety and efficacy of diabetes interventions persist, in part
because randomized clinical trials (RCTs) have not measured their effect on patient …

Diabetes clinical trials: helped or hindered by the current shift in regulatory requirements?

F Zannad, WG Stough, SJ Pocock… - European heart …, 2012 - academic.oup.com
Glycaemic control is an inadequate surrogate marker of cardiovascular event reduction in
patients with type 2 diabetes. Clinical trials to date have been unsuccessful in identifying a …

Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice

MA Bethel, H Sourij - Current cardiology reports, 2012 - Springer
In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust
assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future …

Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes

RR Holman, H Sourij, RM Califf - The Lancet, 2014 - thelancet.com
Few trials of glucose-lowering drugs or strategies in people with type 2 diabetes have
investigated cardiovascular outcomes, even though most patients die from cardiovascular …

Overview of clinical trials on type 2 diabetes mellitus: a comprehensive analysis of the ClinicalTrials. gov database

J Long, R Liang, Q Zheng, G Yuan, Z Xin… - Diabetes, Metabolic …, 2021 - Taylor & Francis
Purpose A better understanding of the current features of type 2 diabetes mellitus (T2DM)-
related clinical trials is important for improving designs of clinical trials and identifying …

Cardiovascular and mortality events in type 2 diabetes cardiovascular outcomes trials: a systematic review with trend analysis

LM Vetrone, F Zaccardi, DR Webb, S Seidu… - Acta …, 2019 - Springer
Aims To investigate cardiovascular disease and mortality trends in control arm participants
of diabetes cardiovascular outcome trials (CVOTs). Methods We electronically searched …

A systematic review of event rates in clinical trials in diabetes mellitus: the importance of quantifying baseline cardiovascular disease history and proteinuria and …

D Preiss, N Sattar, JJ McMurray - American heart journal, 2011 - Elsevier
BACKGROUND: Food and Drug Administration guidance now proposes that cardiovascular
safety of new diabetes medicines be demonstrated. Consequently, trials should include a …

Impact of regulatory guidance on evaluating cardiovascular risk of new glucose-lowering therapies to treat type 2 diabetes mellitus: lessons learned and future …

A Sharma, NJ Pagidipati, RM Califf, DK McGuire… - Circulation, 2020 - Am Heart Assoc
Responding to concerns about the potential for increased risk of adverse cardiovascular
outcomes, specifically myocardial infarction, associated with certain glucose-lowering …

Diabetes medications and cardiovascular outcome trials: Lessons learned.

KV Patel, N de Albuquerque Rocha… - … Clinic journal of …, 2017 - europepmc.org
Diabetes medications and cardiovascular outcome trials: Lessons learned. - Abstract - Europe
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