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How FDA Guidance for Developing Diabetes Drugs is Affecting Trial Design

News Image In 2008, the US Food and Drug Administration (FDA) issued guidance which means that all antidiabetic drugs to be licensed in the future require thorough assessment of cardiovascular safety.

In Current Cardiology Reports, we review the circumstances from which the FDA guidance arose, and examine the differences in clinical trials registered on ClinicalTrials....

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IDF World Diabetes Congress 2011

News Image Professor Holman gave two invited talks, entitled "Legacy Effect of Improved Glycaemic Control in Type 2 Diabetes" and "Estimating Individual CVD Risk in Type 2 diabetes", at the International Diabetes Federation World Diabetes Congress 2011 meeting in Dubai on Tuesday 6th December.


American Heart Association Scientific Sessions 2011

News Image Professor Holman gave an invited talk entitled "Acarbose: The comeback kid?" at the American Heart Association Scientific Sessions 2011 in Orlando on Sunday 13th November 2011.


Paediatric Endocrinology and Diabetes 2011

News Image Professor Holman gave an invited talk entitled "Acarbose: The comeback kid?" at the 39th Meeting of the British Society for Paediatric Endocrinology and Diabetes (BSPED) in London on Friday 11th November 2011.


Canadian National Atherosclerosis Forum 2011

News Image Professor Holman gave a plenary talk entitled "Key Messages from Cardiovascular Trials in T2DM" at the 13th Canadian National Atherosclerosis Forum on Friday 14th October 2011.

Young Diabetologists Forum 2011

Professor Holman gave a keynote speech entitled "From Research Fellow to International Researcher" at the YDF Research day at the University of Warwick on Thursday 29th September 2011. He also gave another, entitled "You and your supervisor - the supervisor's perspective", the following day at a mentoring session for doctoral students.

Professor Holman gives invited lecture at the 2011 EASD meeting

News Image On the morning of 14 September, Professor Rury Holman gave an invited plenary talk in the session 'Warning signals from clinical trials: all that glitters is not gold' at the 47th meeting of the European Association for the Study of Diabetes (EASD), held in Lisbon, Portugal. In his lecture, entitled 'Seeking the truth', he discussed the need for a systematic approach to assessing rapidly evolving data from a myriad of sources that have variable provenance when assessing possible drug-related benefits and harms....

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DTU benefits from share of £95m in research funding

Research at the Diabetes Trials Unit is set to benefit from renewed funding of the Oxford Biomedical Research Centre (OxBRC) by the National Institute for Health Research (NIHR). The OxBRC was recently awarded £95m, an increase of 50% on the previous allocation, to support translational research....

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ACE Regional Investigator Meetings July 2011

News Image This year's Acarbose Cardiovascular Evaluation (ACE) Regional Investigator Meetings were held between 14th and 21st July in six Chinese cities: Beijing, Chengdu, Hangzhou, Guangzhou, Qingdao and Wuhan. We were thrilled by the high attendance, excellent interaction and the interest in the trial shown by Chinese clinicians....

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New offices opened in Beijing

News Image On Friday 15th July 2011 Oxford University (Beijing) Science & Technology Company Ltd. (OUBST) opened its new suite of offices in Beijing's Central Business District....

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Insulin treatment satisfaction in the 4-T trial

News Image In Diabetes, Obesity and Metabolism, we investigate how insulin treatment satisfaction varies between biphasic, prandial or basal insulin treatment groups in the Treat-To-Target in Type 2 diabetes (4-T) trial.

In total, 708 patients taking metformin and sulfonylurea were randomized to biphasic, prandial, or basal insulin....

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EXSCEL launches outside the US

News Image The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial was successfully launched outside of the US in May this year, with four Investigator Meetings conducted in May and June in order to initiate sites.

The first of those investigator meetings took place in Sydney, Australia on 4th May and was closely followed by a meeting in Hong Kong on 6th May for sites in Asia-Pacific....

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Prof. Holman's international contributions recognised by prestigious American Diabetes Association award

News Image Professor Rury Holman has been awarded the American Diabetes Association's prestigious 2011 Harold Rifkin Award for Distinguished International Service in the Cause of Diabetes.

The award, named after former president of the American Diabetes Association Dr. Rifkin, is given to individuals whose outstanding service in the cause of diabetes has been performed with an international perspective and provided global impact....

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DREAM trial washout results

News Image In Diabetes Care, we describe how withdrawing rosiglitazone and ramipril medication affects diabetes incidence after the closeout of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial.

A set of 3,366 subjects who had not developed diabetes by the end of the trial, but who had been taking double-blinded medication, were transferred to single-blinded placebo for 2 to 3 months, and their glycaemic statuses analysed....

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A qualitative study of how treatment recommendations are followed in clinical trials

News Image In the past, qualitative trial research has mainly focused on whether patients and staff understand how trials work, or tried to understand their motivations for taking part. Rarely has research looked into why treatment recommendations are followed, or not, during the trial....

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Rosiglitazone out-performs Metformin and Glyburide in terms of renal function as an early-stage type 2 diabetes treatment

News Image ADOPT (A Diabetes Outcomes Prevention Trial) showed that initial treatment with just rosiglitazone provided more durable glycemic control than metformin or glyburide in patients with recently diagnosed type 2 diabetes. In CJASN, we examine the differences in albumin excretion, renal function and blood pressure over the course of 5 years between the treatment groups....

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TECOS initiation meeting in Prague for new members

News Image On the 24 March 2011, the TECOS team arrived in Prague to host the initiation meeting for the new sites in Europe, Israel and South Africa.

The event covered academic issues as well as the operational management of TECOS....

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Diabetes patients worry about injecting insulin in public more than they do about injecting more frequently

News Image Part of the Treating to Target in Type 2 Diabetes (4-T) trial involved exploring participants' reactions to their intensifying insulin therapy.

In Diabetic Medicine we, along with Nick Jenkins & Julia Lawton of the University of Edinburgh, present a series of qualitative interviews from the trial with participants who had had their insulin therapy intensified....

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More effective glycaemic control seen with rosiglitazone is explained by effects on both β-cell function and insulin sensitivity

News Image The ADOPT study (A Diabetes Outcomes Prevention Trial) showed that treatment with rosiglitazone alone provided somewhat more effective glycaemic control than metformin or glyburide alone, in patients with recently diagnosed type 2 diabetes. In a paper published recently in Diabetes, we examined changes in β-cell function and insulin sensitivity among the three treatments in ADOPT....

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Prof. Rury Holman appointed as an NIHR Senior Investigator

News Image Professor Rury Holman has been appointed as a Senior Investigator by the National Institute for Health Research (NIHR).

A total of 200 NIHR Senior Investigators make up the NIHR College, a selection of some of the UK's most outstanding healthcare researchers....

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Young Diabetologists Forum Finishing School 'well received'

The third YDF OCDEM Finishing School for Specialist Registrars was held at Eynsham Hall on 10th and 11th February 2011. Thirty six final year SpR's - from as far afield as Scotland, Manchester and Yorkshire - met for a meeting that covered complex clinical issues in the management of people with diabetes and provided preparation for securing and starting a consultant post....

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Professor Holman gives invited talk at the Royal College of Physicians

News Image Professor Holman gave an invited talk entitled "Management of Type 2 Diabetes in the 21st century" at the Royal College of Physicians Advanced Medicine Conference in London on Wednesday 16th February 2011.

Impact of personalised cardiovascular risk estimates on physical activity

News Image Informing a person of their risk of developing a disease might be suffiicient impetus to change that person's lifestyle.

This study looked to determine if a personalised 10-year cardiovascular disease (CVD) risk estimate could increase physical activity and other risk reduction behaviours in adults at high risk of CVD....

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Professor Rury Holman co-chairs the Young Diabetologists Forum Finishing School

The 2011 YDF-OCDEM Finishing School for Specialist Registrars (an Advanced Diabetes Course, previously known as the YDF-OCDEM State of the Art Course) will be held on 10th and 11th of February at Eynsham Hall near Oxford.

The course will be chaired by Professors Rury Holman and Edwin Gale and is designed for those coming towards the end of their Specialist Registrar training, soon to embark on consultant careers....

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Outcomes Model 1.3 released

News Image Corrected smoking status check and amputation output and added cohort outputs in Standalone version
Smoking status is now calculated once per loop instead of once per patient
Cumulative Event rate output for events has been replaced with Event rate and Long-term history rate
Diabetes related death has been separated into a separate output sheet from other death
A new group column has been added to the Inputs sheet after the ID column. This allows outputs of 2 patient groups to be compared
The Input Checks have been combined into a single sheet
The Excel macros are now digitially signed


Variations in the gene ATM affect the performance of metformin

News Image We report in Nature Genetics a genome-wide association study for glycemic response to metformin, the most commonly used pharmacological therapy for type 2 diabetes. Our meta-analysis across 3,920 individuals reveals that ATM, a gene known to be involved in DNA repair and cell cycle control, plays a role in glycemic response to metformin.