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New 4-year Study To Examine Effects Of Reducing Insulin Resistance On Cardiovascular Risk
August 29, 2001Takeda UK Ltd (Takeda) today confirmed that 60 UK centres will participate in the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive). PROactive will enroll 5,000 patients in 10 European countries and will last four years. Of the 5,000 patients who will be enrolled it is anticipated that 800 will be from the UK.
The trial will investigate whether ACTOS, the newest member of the thiazolidinedione (TZD) class of medications, can prevent the progression of macrovascular disease, which is associated with cardiovascular events such as myocardial infarction in type 2 diabetes patients.
"Macrovascular disease is the biggest problem in diabetes", said Professor John Dormandy of St George's Hospital, London, UK and Chairman of PROactive. "Heart attacks and strokes are the killers. In the search for the abnormality behind these cardiovascular events we have tried controlling blood sugar, lowering lipids and lowering blood pressure. Although all of these are beneficial, when you look at optimally treated people without diabetes and optimally treated people with diabetes, those with diabetes are still at two to three times the risk of macrovascular events. We believe that another factor may be at work, and the best hypothesis that we have is that insulin resistance - which is found in the majority of people with type 2 diabetes - is the problem."
The Principal Investigator for PROactive in the UK will be Professor John Betteridge, Professor of Endocrinology and Metabolism, University College, London who commented "This is a very exciting clinical study. It will mirror the real-life day-to-day issues facing all those who treat patients with type 2 diabetes. In PROactive, pioglitazone will be added to whatever treatment the patient has already been prescribed by their physician be this tablets or insulin." Professor Betteridge further added "We know from the UKPDS that tight control of glucose levels and blood pressure can reduce the risk of microvascular complications. Pioglitazone is especially exciting as, in addition to helping control glucose in combination therapy, it has a positive effect on the lipid profile. Compared to placebo, pioglitazone decreased triglycerides and increased high density lipoprotein (good) cholesterol (HDL-C) with no significant effect on low density lipoprotein cholesterol (LDL-C). These effects may help to reduce cardiovascular risk factors in patients with Type 2 diabetes".
Actos® is licensed for use in the oral combination treatment of Type 2 diabetes mellitus in patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin (in obese patients) or a sulphonylurea (in patients for whom metformin is not tolerated or contraindicated). ACTOS® is taken once daily and is available in 15 and 30 milligram tablets.
Magellan Medical Communications
The Principal Investigator for PROactive in the UK will be Professor John Betteridge, Professor of Endocrinology and Metabolism, University College, London who commented "This is a very exciting clinical study. It will mirror the real-life day-to-day issues facing all those who treat patients with type 2 diabetes. In PROactive, pioglitazone will be added to whatever treatment the patient has already been prescribed by their physician be this tablets or insulin." Professor Betteridge further added "We know from the UKPDS that tight control of glucose levels and blood pressure can reduce the risk of microvascular complications. Pioglitazone is especially exciting as, in addition to helping control glucose in combination therapy, it has a positive effect on the lipid profile. Compared to placebo, pioglitazone decreased triglycerides and increased high density lipoprotein (good) cholesterol (HDL-C) with no significant effect on low density lipoprotein cholesterol (LDL-C). These effects may help to reduce cardiovascular risk factors in patients with Type 2 diabetes".
Actos® is licensed for use in the oral combination treatment of Type 2 diabetes mellitus in patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin (in obese patients) or a sulphonylurea (in patients for whom metformin is not tolerated or contraindicated). ACTOS® is taken once daily and is available in 15 and 30 milligram tablets.
Magellan Medical Communications
Diabetes Current Events and Diabetes News RSSFlaxseed oil and osteoporosis
Animal studies suggest that adding flaxseed oil to the diet could reduce the risk of osteoporosis in post-menopausal women and women with diabetes, according to a report to be published in the International Journal of Food Safety, Nutrition and Public Health.
Diabetes surgery summit consensus lays foundation for new field of medicine
A first-of-its-kind consensus statement on diabetes surgery is published online today in the Annals of Surgery.
ESC to give talks on Diabetes in three cities in China
As a result of successful events organised last year, a second Joint Scientific Forum, organised by the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD), two of the most respected professional medical organisations in Europe, will be held from 27-29 November at three venues across China - Beijing, Shanghai and Guangzhou.
New research shows versatility of amniotic fluid stem cells
For the first time, scientists have demonstrated that stem cells found in amniotic fluid meet an important test of potential to become specialized cell types, which suggests they may be useful for treating a wider array of diseases and conditions than scientists originally thought.
First reconstitution of an epidermis from human embryonic stem cells
Stem cell research is making great strides. This is yet again illustrated by a study carried out by the I-STEM* Institute (I-STEM/ Inserm UEVE U861/AFM), published in the Lancet on 21 November 2009. The I-STEM team, directed by Marc Peschanski has just succeeded in recreating a whole epidermis from human embryonic stem cells.
An atomic-level look at an HIV accomplice
Since the discovery in 2007 that a component of human semen called SEVI boosts infectivity of the virus that causes AIDS, researchers have been trying to learn more about SEVI and how it works, in hopes of thwarting its infection-promoting activity.
Scripps research scientists find new link between insulin and core body temperature
A team led by scientists at The Scripps Research Institute have discovered a direct link between insulin-a hormone long associated with metabolism and metabolic disorders such as diabetes-and core body temperature.
Scientists find molecular trigger that helps prevent aging and disease
Researchers at Mount Sinai School of Medicine set out to address a question that has been challenging scientists for years: How do dietary restriction-and the reverse, overconsumption-produce protective effects against aging and disease?
Pivotal study for PSD502 -- the first potential treatment for premature ejaculation
At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" - AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).
Night Beat, Overtime and a Disrupted Sleep Pattern Can Harm Officers' Health
A police officer who works the night shift, typically from 8 p.m. to 4 a.m., already is at a disadvantage when it comes to getting a good "night's" sleep.
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