Diabetes archive Feb03
- Report to Congress frames diabetes research agenda
- Landmark study shows Xenical prevents or delays development of type 2 diabetes
- Study suggests lower Body Mass Index guidelines to block diabetes
- New data show fast and significant weight loss with Xenical sustained over time
Report to Congress frames diabetes research agenda
NEW YORK, N.Y., October 30, 2002 -- The National Institutes of Health (NIH) has issued a detailed report by a working group of diabetes experts highlighting recent progress made in diabetes research and looking ahead to future challenges and opportunities. The report, entitled, Conquering Diabetes: Highlights of Program Efforts, Research Advances and Opportunities, was produced by the Congressionally established Diabetes Research Working Group (DRWG) as a follow-up to a similar report released in 1999.
Labeled a "Scientific Progress Report," the new publication is intended to serve as both an analysis of recent advances, both clinical and basic, in both type 1 (juvenile) and type 2 diabetes, as well as a guide to where the government and scientific community should focus future research.
NIH compiled the report to provide Members of Congress with the latest and most accurate diabetes information and guide them in making diabetes research funding decisions. As with the first report, JDRF was instrumental in providing information and making recommendations about the goals of and research opportunities for type 1 diabetes research.
The 2002 report offers ways to address research areas the continuing challenges that remain three years after the initial recommendations. Although the 1999 DRWG report called for a federal appropriation of $1.5 billion for diabetes research in fiscal year 2003, the NIH now estimates it will allocate only $845 million toward research this year. The new "Conquering Diabetes" provides a series of expanded research opportunities by which additional investments will help find new treatments and a cure for the disease.
"The report effectively documents the enormous impact of the previous research investments in diabetes and outlines the potential value of future additional research funding." says JDRF Chief Scientific Officer Robert Goldstein, M.D. "JDRF will continue to partner and work closely with NIH to effectively coordinate research funding recommendations in order to maximize the benefits to patients from this research effort.
Shared visions for a cure
The DRWG recommendations strongly reinforce JDRF's goal-oriented approach to research a program response to the needs of people with diabetes. The report recognizes the immediate and long-term concerns of people with diabetes, which JDRF has organized into its three broad research goals:
- Restoration of normal blood sugar levels
- Prevention and improved treatment of complications
- Prevention of diabetes.
In 1997, JDRF's Research Task Force I established a "roadmapping" methodology to set clear research objectives. In 2000, JDRF's Research Task Force II updated the research plan, plotting out new research opportunities and priority areas, including a focus on genetics and genomics, and on embryonic stem cell research.
The success of Task Forces I and II allowed JDRF to further focus its efforts on maximizing diabetes research progress. In 2000, JDRF through its advocacy was responsible for obtaining $100 million in additional annual funding for type 1 diabetes research from the U.S. government, helping to fill the research pipeline with new ideas and refined approaches.
In 2001, faced with new opportunities and clinical breakthroughs, and the need to best focus its own resources, leverage new resources from its partners and collaborators, and provide global leadership in this arena, Task Force III surveyed the entire diabetes research "landscape" a global view of all research funded by public and private sectors including the NIH and identified those areas where JDRF focus would have the most impact.
Now, with the release of the new report, JDRF applauds the DRWG's recommendations, which correspond with the primary objectives of JDRF's three main goal areas and complement JDRF research funding efforts.
Restoration and maintenance of normal blood sugar levels
Realization of this goal would be a major advance in solving the problems associated with diabetes and the development of complications. The DRWG's progress report emphasizes the need for expanded research to normalize blood sugar in people with type 1 diabetes. The most promising development since the original DRWG report is the success of islet transplantation using the Edmonton Protocol, which has achieved dramatically improved success rates in restoring blood sugar control.
Specific DRWG recommendations include:
- Expand efforts to develop new sources of islets and beta cells, which could be transplanted into patients with type 1 diabetes. This includes stimulating beta cell growth in the body and in laboratory cultures.
- Further intensify basic research on beta cell biology to understand how they develop and function, and what happens after they are transplanted. This includes providing researchers with a comprehensive set of novel tools to investigate the beta cell, such as noninvasive imaging devices that allow study of beta cell function inside the body.
- Continue testing of therapies to preserve beta cell function in patients at risk for diabetes by modulating the immune system.Increase efforts to make advances in achieving immune tolerance, which would allow patients to receive transplanted islets without having to take immune suppressing drugs that put them at risk. This includes fostering collaboration between basic and clinical researchers through projects like the Immune Tolerance Network, a project co-funded by JDRF and the NIH, devoted to research that leads to tolerance of transplanted tissue and prevention of autoimmune conditions.
- Develop more effective and less invasive methods for measuring
and monitoring blood glucose levels.
Prevention and treatment of complications
DRWG's Scientific Progress Report describes prevention of complications as a "formidable challenge" that will require "a sustained and substantial research effort." The report emphasizes that vascular complications of diabetes are responsible for the increased risk of many related health problems.
Specific DRWG recommendations include:
- Develop animal models and surrogate markers (detectable factors that can indicate impending disease conditions)
- Identify genes that contribute to susceptibility to complications, including the collection of samples from participants in the large scale Diabetes Control and Complications Trial (DCCT) and the Genetics of Kidneys in Diabetes (GoKinD) Study.
- In addition, increase the use of new technologies such as DNA microarrays (also called "gene chips"), which can measure the expression of many genes in a single experiment.Identify and exploit targets for drug development for preventing complications based on molecular understanding of the pathways involved in glucose toxicity
Prevention of type 1 diabetes
The prevailing scientific view is that type 1 diabetes is caused by genetic and environmental factors which, acting in concert, cause the body's immune system to attack and destroy its own insulin-producing beta cells. JDRF's Task Force III identified three areas of research focus: genetics of type 1 diabetes and population studies, identify environmental factors, and assays to predict disease development.
DRWG includes recommendations applying to all of these areas, correlating with JDRF objectives:
- Identify genes that predispose for type 1 diabetes through large-scale collaborative efforts such as the Type 1 Diabetes Genetics Consortium, as well as the comparison of genomes of multiple organisms.
- Look for environmental triggers through international studies.
- Develop better assays to monitor and predict the development of diabetes, possible combined in the future with genetic tests to further improve predictive powers.
Diabetes kills one American every three minutes and accounts for 25 percent of all Medicare expenditures. It afflicts 120 million people worldwide, and the World Health Organization (WHO) estimates that number will increase to 300 million by 2025. JDRF looks forward to continued work in tandem with the U.S. government to reach the only acceptable objective: finding a cure.
In addition to posting the report on its Web site, beginning in November, NIDDK will make single copies of the report available free of charge from its National Diabetes Information Clearinghouse at 1-800-860-8747.
Landmark study shows Xenical prevents or delays development of type 2 diabetes
BASEL, SWITZERLAND (26 August 2002) -- Roche announced today that the results of the 4-year landmark XENDOS study -- involving 3304 patients -- demonstrated that the weight loss medication Xenical can prevent or delay the development of type 2 diabetes.
The XENDOS study data also showed significant and sustained weight loss over the long term. 
Commenting on the results presented at the 9th International Congress on Obesity (ICO) in Sao Paulo, Brazil, Professor Lars SjÃƒÂ¶strÃƒÂ¶m the XENDOS principal investigator, said: "Against the background of several studies which show lifestyle intervention in the prevention of diabetes to be successful, it is a significant step forward to be able to show that treatment with Xenical in combination with lifestyle modification is more effective than lifestyle intervention alone both in diabetes prevention and weight loss."
"The outstanding XENDOS study results show that Xenical has a key role in combating the diabetes epidemic. Diabetes is a dangerous and expensive complication to obesity. An effective and safe drug that helps to prevent or delay the disease, as well as to maintain weight loss over the long term, is of real value for millions of overweight people at risk of developing diabetes," said William M. Burns, head of the Pharmaceutical division at Roche.
XENDOS study results showed that:
- Xenical-plus-lifestyle intervention is significantly better than lifestyle intervention alone in preventing or delaying the development of type 2 diabetes.
- The risk of developing type 2 diabetes was 37% lower in people treated with Xenical-plus- lifestyle intervention compared with lifestyle intervention alone.
- Weight loss, both short and long term, was significantly greater with Xenical-plus- lifestyle intervention compared with lifestyle intervention alone (-11.4 vs -7.5 kg at one year and -6.9 vs -4.1kg at four years).
- Weight loss was successfully maintained in the long-term, with almost twice as many Xenical treated patients losing more than 10% body weight at the end of four years of treatment (26% vs 16%). Even more patients had lost more than 5% body weight after four years (53% vs 37%), an amount that has been shown to have clear health benefits.
- Xenical-treated patients had significant, sustained, long-term improvements in cardiovascular risk factors such as blood pressure and lipid profile compared with lifestyle intervention alone.
- Treatment with Xenical for 4 years was safe and well-tolerated. Xenical is now the only weight loss medication available whose safety has been studied for this length of time.
Type 2 diabetes
Worldwide, the prevalence of overweight and obesity is growing at an epidemic rate, with a corresponding surge in the incidence of type 2 diabetes.
It is estimated that there are at least 150 million people in the world with diabetes and that type 2 diabetes accounts for 90 per cent of all cases. This figure is expected to double over the next 25 years.
Because of the severe health & cost complications of type 2 diabetes, organisations such as the International Diabetes Federation (IDF) have called for increased efforts to prevent the development of type 2 diabetes. President of the IDF, Professor George Alberti, stated recently that "the importance of diabetes prevention cannot be underestimated". 
Excess weight is well recognised as the most important modifiable risk factor for the development of type 2 diabetes. A number of recent studies have shown that lifestyle intervention (to reduce weight and increase physical activity) has a dramatic effect on delaying or preventing the development of type 2 diabetes.  
As a result of these findings, authorities currently recommend lifestyle intervention as the most effective treatment approach to preventing type 2 diabetes, particularly as there are additional health benefits such as reduced blood pressure, reduced cholesterol levels and improved quality of life. 
Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 per cent to effectively promote weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. Since it was first marketed in 1998, there have been more than 13.5 million patient treatments with Xenical world-wide. Xenical is licensed for weight management in 149 countries around the world.
For further information please go to: www.managingyourweight.com
Xenical Weight Management Programmes
Roche has developed Xenical weight management programmes (WMPs) for healthcare professionals to use with their patients. The programme aims to help patients set and reach realistic weight goals while modifying their dietary intake and behaviour in the long-term. The programmes are individually tailored to help people achieve their weight loss goals, and maintain weight loss, through healthy eating, physical activity, behaviour modification and pharmacotherapy.
Roche provides free patient support programmes in around 50 countries worldwide to help people taking Xenical. Recent data demonstrated that patients enrolled in Xenical WMPs can significantly improve the levels of weight loss achieved and can increase their overall satisfaction and compliance with treatment.
1) Sjostrom L. et al XENDOS (XENical in the prevention of Diabetes in Obese Subjects): A Landmark Study. Poster presented at ICO, Sao Paulo, 2002.
2) Kumanyika S, Jeffrey RW, Morabia A, et al. Obesity prevention: the case for action. Int J Obes Relat Metab Disord 2002;26: 425-36.
3) Diabetes Prevention Study (DPS). NEJM, May 3, 2001, Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. Tuomilehto et al.
4) Diabetes Prevention Program (DPP). NEJM, February 7, 2002. Reduction in the incidence in type 2 diabetes with lifestyle intervention or metformin.
5) ADA/NIDDK (Diabetes Care).
Study suggests lower Body Mass Index guidelines to block diabetes
CHAPEL HILL, N.C. (13 June, 2002) -- The recommended upper limit of a healthy body mass index (BMI) -- the term doctors and others use to indicate how much people weigh for how tall they are -- might need to be revised downward to protect people from becoming glucose intolerant or developing type 2 diabetes, a new University of North Carolina (UNC) at Chapel Hill study suggests.
Conducted with information gathered from 2,626 aborigines in remote parts of Australia, the study also suggests doctors should recommend lower BMIs for some groups than for others. Whites, for example, appear to be somewhat less sensitive to the unhealthy effects of excess weight than blacks and various indigenous populations around the world.
A report on the findings appears in the June issue of the journal Diabetes Research and Clinical Practice, which has just been published. Lead author is Dr. Mark Daniel, assistant professor of health behavior and health education at the UNC School of Public Health.
"We calculate people's body mass index by dividing their weight in kilograms by their height in meters squared," said Daniel, also an assistant professor of epidemiology. "The resulting number, which is considered to range from 20 to 25 in healthy people, is a better indicator of how much extra weight a person carries around as fat than their weight alone because, obviously, people of the same ages and weights vary considerably in height."
In the new study, Daniel worked with Drs. Kevin Rowley of the University of Melbourne, Robyn McDermott of the Tropical Public Health Unit of Queensland Health in Cairns and Kerin O'Dea of the Menzies School of Health Research in Darwin. They examined Australian aborigines in 15 remote settlements since diabetes and the impaired glucose tolerance (IGT) that precedes it have grown as health threats almost worldwide. Areas studied ranged from central desert regions of the Outback to lands subject to tropical monsoon rains in the north.
Besides calculating subjects' body mass indexes, researchers gathered data on how well or poorly their bodies processed glucose while fasting and two hours after eating. They also divided subjects into three age groups between 15 and 34.9, between 35 and 44.9 and over 45 years -- as well as five BMI groups below 22, between 22 and 24, 25 to 29.9, 30 to 34.9 and 35 or more.
BMI scores from 25 to 30 are considered overweight, and scores above 30 indicate obesity.
"What we found was that the age- and sex-adjusted prevalence of impaired glucose tolerance was 14.9 percent and of diabetes was 14.8 percent," Daniel said. "For both conditions, the prevalence of disease increased with increasing BMI."
The age- and sex-adjusted risk of developing impaired glucose tolerance was three times greater for people with BMIs of 22 or more compared to people with lower BMIs, he said. The risk of diabetes was four times greater for subjects with BMIs of 22 or more. Even in just the 22 to 25 BMI range, which is supposedly healthy, the risk of having diabetes was close to three times greater.
"We also calculated that if we could prevent gains in BMI beyond 22, we could prevent an estimated 46 percent of diabetes cases and 34 percent of impaired glucose tolerance cases, which is just astounding," Daniel said.
The UNC report is among the first of several studies showing that an increased risk of diabetes exists in the 22 to 25 BMI range, which was established based on earlier research on whites and, until recently, has rarely been questioned, he said.
"The world health community might want to revise the recommended upper healthful limit downward, especially among such groups as American and Canadian Indians, Pacific Islanders, Africans and U.S. blacks and many indigenous people, who all appear to be at increased risk," Daniel said. "We believe programs to reduce the risks of diabetes are urgently needed in many parts of the world, including Australia and the United States."
Source: University of North Carolina at Chapel Hill/American Diabetes Associaion
New data show fast and significant weight loss with Xenical sustained over time
GRAZ, AUSTRIA (4 June, 2002) -- The weight loss medication Xenical helps patients achieve rapid and sustained weight loss according to the results of a new study designed to reflect real world usage of Xenical in clinical practice.1
The 12 month study of 430 overweight men and women (BMI of 30-43 kg/m2), was designed to assess the effectiveness of Xenical in patients who are responsive to treatment. Patients who achieved 5 per cent (approximately 5kg) weight loss after 3 months and maintained this after a further 3 months of Xenical treatment, were followed for one year.
During this time weight loss and other health improvements, such as reductions in blood pressure, were assessed. The results suggest that the efficacy of Xenical in a real-life clinical practice setting is even greater than that demonstrated previously in clinical trials:
- The greatest weight loss was seen in the first four weeks of treatment, with an average weight loss of 4.1 kg
- Three out of four people achieved 5 per cent weight loss by month three, losing an average of 8kg
- By month 6, 92 per cent of these people had maintained at least 5 per cent weight loss, with an average weight loss of 10.9kg.
The average weight loss after one year was 11.6 kg. One in two patients in the study lost more than 10 per cent of their initial weight, and over 8 in ten people lost more than 5 per cent an amount of weight loss shown to clinically improve the health and well-being of overweight people. 2
Commenting on the results, lead study investigator Professor Hermann Toplak from the Karl-Franzens-UniversitÃƒÂ¤t, Graz, Austria said, "These results demonstrate the significant benefits of rapid and continuous weight loss with Xenical in a clinical practice setting. Patients who respond rapidly to treatment continue with treatment and achieve long-term success."
Results also demonstrated significant health gains associated with weight loss with Xenical. Specifically, people treated with Xenical achieved improvements in:
- Waist circumference: An average reduction of 10.8 cm was achieved after one year. Excess fat around the waist is associated with insulin resistance, high blood sugar, high cholesterol levels and high blood pressure
- Blood pressure (bp): In patients with hypertension, mean systolic and diastolic blood pressure were reduced by 18.1mmHg and 9.9mmHg respectively
- Cholesterol: The lipid profile of patients was markedly improved: mean LDL-cholesterol (bad' cholesterol) levels were reduced by 10.7 per cent and mean total cholesterol levels by 6.8 per cent.
The reductions in blood pressure are a key finding as the number of overweight people with hypertension is almost three times higher than the number of adults with a healthy weight.3 Xenical is the only prescription weight-loss medication, which can be used in patients with hypertension or uncontrolled hypertension.4
Xenical's mode of action is unique. Unlike appetite suppressants, which have a history of withdrawals because of safety concerns, Xenical does not act on the central nervous system. As a result of Xenical's non-systemic mode of action, it has a safety and tolerability profile, which makes it appropriate for use in a wide range of people. This is particularly important within the area of overweight/obesity, where a significant number of people suffer from, or are at risk of cardiovascular disease.
- Toplak H. Oral Presentation at Seville, Roche Event, 31 May 1 June 2002
- Goldstein DJ. International Journal of Obesity (1992). 16:397-415
- Pi-Sunyer FX. "Medical Hazards of Obesity." Ann Intern Med (1993). 119: 655-660
- Yanovski S et al. Obesity. NEJM 2002; 346 (8): 591-602
Source: Shire Health International/American Diabetes Association
Posted: October 2002
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