New results from ADVANCE trial at International Diabetes Federation (IDF) Congress 2009

Results to provide fresh insights into cardiovascular risk factors in type 2 diabetes and confirm benefit of intensive glucose-lowering treatment

LONDON, Sept. 22, 2009--New results from ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), the largest clinical trial ever performed in patients with type 2 diabetes worldwide, will be presented at the International Diabetes Federation (IDF) Congress, 18-22 October 2009 in Montreal, Canada. These data will provide new insights into factors predicting risks of complications in type 2 diabetics and confirm the benefits of intensive glucose control in all clinical settings.

"ADVANCE clearly showed that the combination of routine blood pressure lowering and tighter glucose control confers very substantial benefits for the millions of people living with type 2 diabetes,” said Principal Investigator Professor John Chalmers from The George Institute for International Health, Australia. “People with diabetes have a two to four-fold greater risk of experiencing a cardiovascular event compared to non-diabetics. These new analyses will allow us to develop a new ‘risk engine’ to estimate CV risk and help reinforce guidelines for lowering haemoglobin A1c (HbA1c) levels in type 2 diabetes patients.”

New ADVANCE data at IDF The following abstracts have been accepted for presentation at the IDF congress: - Chalmers J, Zoungas S, Ninomiya T et al. New results from ADVANCE (IDF invited talk 22 October 2009) - Marre M, Chalmers J, Zoungas S et al. The Efficacy of lowering HbA1c with a gliclazide MR-based intensive glucose lowering regimen in the ADVANCE trial (Poster – Monday 19th October) - Zoungas S, Patel A, Neal B et al. ADVANCE-ON: A post-trial observational study (Oral presentation – Wednesday 21st October) - Zoungas S, Ninomiya T, Patel A et al. Association of glycaemic exposure with macrovascular and microvascular complications of type 2 diabetes: ADVANCE prospective observational analyses (Poster - Monday 19th October) - Kengne AP, Patel A, Colagiuri S et al. Derivation of the ADVANCE models for predicting the risk of major cardiovascular disease in people with diabetes (Oral presentation – Tuesday 20th October) - Kengne AP, Patel A, Colagiuri S et al. Predictive accuracy of the Framingham and UKPDS risk equations in estimating the probability of cardiovascular events in a multi-national contemporary population with diabetes (Oral presentation – Tuesday 20th October)

Over 11,000 patients from more than 20 countries participated in ADVANCE. Further analyses from this large patient cohort provide an opportunity to examine the effects of intensive glucose control based on Diamicron MR in a wide range of patients in different clinical settings and validate a new tool or ‘risk engine’ for predicting the risk of cardiovascular events that could potentially replace the existing Framingham and UKPDS risk equations.

ADVANCE-ON ADVANCE showed a positive trend towards reducing severe cardiovascular events in diabetes patients who received intensive glucose control. More recent data suggest that the benefits, including mortality reduction, of intensive glucose control strategies may emerge in the longer term. For this reason, the study investigators have decided to continue the follow-up of the ADVANCE patients. The ADVANCE-ON project will be announced at the IDF Congress. The results of this study are eagerly awaited as they are expected to play a pivotal role in defining the future clinical management of type 2 diabetes patients worldwide.

For full copies of all the abstracts highlighted above, please visit: http://www.worlddiabetescongress.org/pages/programme-update

Notes to editors

About ADVANCE ADVANCE (Action in Diabetes and Vascular Disease) was initiated and designed by the researchers at Australia’s George Institute for International Health and co-sponsored by the Australian government’s National Health and Medical Research Council, and Servier. The multicenter, randomised, placebo controlled study involved a total of 11,140 patients with Type 2 diabetes from 20 countries worldwide with a five year follow-up.

The choice of Diamicron MR was based on its well known efficacy and safety profile, as proven by millions of diabetic patients treated every day.

About The George Institute The George Institute for International Health is an internationally-recognised health research organisation, undertaking high impact research across a broad health landscape. It is a leader in the clinical trials, health policy and capacity-building areas.

About The National Health & Medical Research Council of Australia The National Health & Medical Research Council of Australia is the Australian Government’s peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.

About Servier Servier is France’s leading independent pharmaceutical company and the second largest French drug company worldwide. Servier has been committed to optimisation of the treatment of type 2 diabetes for over 30 years, through the discovery of original antidiabetic agents and numerous activities promoting research and education. The research funding arm of French pharmaceutical company Servier is the Institut de Recherche International Servier.

About Diamicron MR Diamicron MR is an effective and safe once daily oral antidiabetic agent containing a patented modified-release formulation of the active ingredient gliclazide. In addition to its blood glucose lowering effects, the drug has well-documented vascular protective properties. Diamicron MR is registered by Servier in some countries also as Diamicron 30 mg, Diaglucide MR 30mg, Gluctam MR 30 mg, Diaprel MR, Diabeton MR, Diamicron Uno 30 mg, Diabeton MB, Uni Diamicron, Diamicron LM 30 mg, Unidiamicron, Dianormax MR, Diamicron MR Tablets 30 mg, Diamicron 30 mg MR, Dramion 30mg.

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Moira Gitsham Tonic Life Communications Moira.gitsham@toniclc.com

Monica Gounaropoulos Tonic Life Communications Monica.g@toniclc.com

Posted: September 2009

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