ADVANCE

Julius Clinical coordinated the entire European part of the ADVANCE trial, to date the largest clinical trial in diabetes ever conducted.

Therapeutic areas

Total patients

26

Total sites

16

Status

Finished

The phase III trial was conducted in more than 20 countries worldwide to investigate the effects of routine antihypertensive therapy and glucose control therapy in more than 11,000 patients with type 2 diabetes. The study found that initial tight control of blood glucose and blood pressure was associated with significant reductions in the risk of renal events, death from cardiovascular causes, and death from any cause, over the next 4-5 years.

The efficient design and large scale of the ADVANCE trial contributed to the large impact that the findings have had on clinical practice in recent years. The ADVANCE-ON trial is currently underway, following up patients from the initial study for a further 5 years to investigate long-term effects.

Services

Project Management

ADVANCE had eighteen months for recruitment, an average of five years follow-up and achieved database lock in nine days.

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Site Management & Monitoring

Julius Clinical had the task to manage the continental European sites from start-up to closure including RA/EC submissions.

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Data Management

For this trial, Julius Clinical created a specific study website in which all data could be entered.

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Publications

Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes

Sophia Zoungas, M.D., Ph.D., John Chalmers, M.D., Ph.D., Bruce Neal, M.D., Ph.D., Laurent Billot, M.Sc., Qiang Li, M.Biostat., Yoichiro Hirakawa, M.D., Ph.D., Hisatomi Arima, M.D., Ph.D., Helen Monaghan, B.Sc., Rohina Joshi, M.D., Ph.D., Stephen Colagiuri, M.D., Ph.D., Mark E. Cooper, M.D., Ph.D., Paul Glasziou, M.D., Ph.D., Diederick Grobbee, M.D., Ph.D., Pavel Hamet, M.D., Ph.D., Stephen Harrap, M.D., Ph.D., Simon Heller, M.D., Liu Lisheng, M.D., Giuseppe Mancia, M.D., Michel Marre, M.D., Ph.D., David R. Matthews, B.M., Ph.D., Carl E. Mogensen, M.D., Ph.D., Vlado Perkovic, M.D., Ph.D., Neil Poulter, M.D., F.Med.Sci., Anthony Rodgers, M.D., Ph.D., Bryan Williams, M.D., Ph.D., Stephen MacMahon, D.Sc., Ph.D., Anushka Patel, M.D., Ph.D., and Mark Woodward, Ph.D. for the ADVANCE-ON Collaborative Group.

N Engl J Med. 2014 Oct 9;371(15):1392-406. doi: 10.1056/NEJMoa1407963.

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Intensive blood glucose control and vascular outcomes in patients with Type 2 Diabetes

ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. 

N Engl J Med. 2008 Jun 12;358(24):2560-72. Epub 2008 Jun 6. PubMed PMID: 18539916.

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Severe Hypoglycemia and Risks of Vascular Events and Death

Zoungas S, Patel A, Chalmers J, de Galan BE, Li Q, Billot L, Woodward M, Ninomiya T, Neal B, MacMahon S, Grobbee DE, Kengne AP, Marre M, Heller S; ADVANCE Collaborative Group.

N Engl J Med. 2010 Oct 7;363(15):1410-8. PubMed PMID: 20925543.

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Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial

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