World’s Largest Study on Insulin Therapy Completes Recruitment With 60,000 Patients

ZURICH, July 19, 2010 /PRNewswire/ — Today, Novo Nordisk announced the landmark recruitment of the 60,000th patient in the A1chieve(R) study – an observational study designed to investigate the effects of modern insulins in the management of type 2 diabetes.[1]

Spanning 28 countries across 4 continents and involving more than 3300 physicians, A1chieve(R) is set to be the world’s largest observational study in insulin therapy.

Approximately 70 percent of the world’s 285 million people with diabetes are living in these 28 emerging countries where there is a rising need and interest to look at differences in physician decisions in the management of diabetes.[2]

“Multinational observational studies like A1chieve(R) provide valuable insights in the way current therapies are applied when it comes to varying cultural, economic and epidemiological circumstances,” said Philip Home, Professor of Diabetes Medicine at Newcastle University England and Chair of the A1chieve(R) Global Advisory Board.

In order to mimic the natural secretion of insulin in the body, commercially available insulin preparations are used in different ways (regimens) based on an individual’s need and prevailing local practices. However it is important to evaluate these different regimens in a real life setting.

“Once completed A1chieve(R) will provide locally relevant information on the effective use of modern insulins across different regimens. This information could be further useful to inform and improve the local guidelines on the management of type 2 diabetes” added Professor Home.

Jesper H0iland, Senior Vice President, Novo Nordisk Region International Operations A/S said “The A1chieve(R) study is another major initiative demonstrating our commitment as leaders in the field of diabetes care. Our vast experience and unmatched presence in the emerging countries has enabled us to carry out such a unique and large scale research activity of clinical importance.”

The results of this multinational study will be available in 2011.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 28,500 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit http://www.novonordisk.com.

Further information:

References

1. Siddharth N. Shah, Leon Litwak, Jihad Haddad, Praful N. Chakkarwar and
Issam Hajjaji. The A1chieve(R) study: a 60,000-person, global,
prospective, observational study of basal, meal, and biphasic insulin
analogs in daily clinical practice. Diabetes Research and Clinical
Practice 88S (2010).

2. IDF Diabetes Atlas 4th Edition, International Diabetes Federation,
2009. http://www.diabetesatlas.org.

Experts Explore Emerging Evidence Linking Diabetes and Cancer

ALEXANDRIA, VA, Jun 16 (MARKET WIRE) —
A new consensus statement of experts assembled by the American Diabetes
Association and the American Cancer Society reviews emerging evidence
that suggests cancer incidence is associated with diabetes as well as
certain diabetes risk factors and treatments. The new report reviews the
state of science concerning the association between diabetes and cancer
incidence/prognosis; risk factors common to both diseases; possible
biologic links between diabetes and cancer risk; and whether diabetes
treatments influence the risk of cancer or cancer prognosis. In addition,
the report outlines key unanswered questions for future research.

Diabetes and cancer are common diseases that have a tremendous impact on
health worldwide. Epidemiologic evidence suggests that people with
diabetes are at a significantly higher risk of many forms of cancer. Type
2 diabetes and cancer share many risk factors, but potential biologic
links between the two diseases are not completely understood. Moreover,
evidence from observational studies suggests that some medications used
to treat hyperglycemia are associated with either an increased or reduced
risk of cancer. Against this backdrop, the American Diabetes Association
and the American Cancer Society convened a consensus development
conference in December 2009. After a series of scientific presentations
by experts in the field, the writing group independently developed a
consensus report to address important questions: Is there a meaningful
association between diabetes and cancer incidence or prognosis? What risk
factors are common to both cancer and diabetes? What are possible
biologic links between diabetes and cancer risk? And do diabetes
treatments influence cancer risk or cancer prognosis?

For each of these areas, the authors were asked to address current gaps
in evidence and potential research and epidemiologic strategies for
developing more definitive evidence in the future. Below is a summary of
their findings and recommendations.*

– Diabetes (primarily type 2) is associated with an increased risk of
some cancers (liver, pancreas, endometrium, colon/rectum, breast, and
bladder). Diabetes is associated with a reduced risk of prostate
cancer. For some other cancer sites, there appears to be no
association or the evidence is inconclusive.
– The association between diabetes and some cancers may be due in part
to shared risk factors between the two diseases such as aging,
obesity, diet, and physical inactivity.
– Possible mechanisms for a direct link between diabetes and cancer
include hyperinsulinemia, hyperglycemia, and inflammation.
– Healthy diet, physical activity, and weight management reduce the risk
and improve outcomes of type 2 diabetes and some forms of cancer and
should be promoted for all.
– Patients with diabetes should be strongly encouraged by their health
care professionals to undergo appropriate cancer screenings as
recommended for all people of their age and sex.
– The evidence for specific drugs affecting cancer risk is limited, and
observed associations may have been confounded by indications for
specific drugs, effects on other cancer risk factors such as body
weight and hyperinsulinemia, and the complex progressive nature of
hyperglycemia and pharmacotherapy in type 2 diabetes.
– Although still limited, early evidence suggests that metformin is
associated with a lower risk of cancer and that exogenous insulin is
associated with an increased cancer risk. Further research is needed
to clarify these issues and evaluate the possible association of
insulin and other diabetes medications with the risk of cancer.
– Cancer risk should not be a major factor when choosing between
available diabetes therapies for the average patient. For selected
patients with a very high risk of cancer occurrence (or for recurrence
of specific cancer types), these issues may require more careful
consideration.
– Many research questions remain.

“Traditionally there hasn’t been much overlap between research in
cancer and in diabetes,” says Edward Giovannucci, MD, SCD, co-chair of
the consensus report group. “But recently it’s become clearer that there
are fascinating links between the two. Our summary may raise more
questions than provide answers, but we hope that it will spur additional
studies.”

“The vast majority of patients with diabetes need not consider cancer
risk when weighing their diabetes therapy options,” added David M.
Harlan, MD, co-chair of the consensus report group, “Only patients with a
very high risk for cancer occurrence, or re-occurrence, may wish to
carefully consider their options. Even then, the association appears to
exist for some cancer types, and not for others. We have much to learn.”

*Recommendations in this report are solely the opinions of the authors
and do not represent the official position of the American Diabetes
Association or the American Cancer Society

Article: “Diabetes and Cancer: A Consensus Report.” Edward Giovannucci,
MD, ScD; David M. Harlan, MD; Michael C. Archer, MA, PhD, DSC; Richard M.
Bergenstal, MD; Susan M. Gapstur, PhD; Laurel A. Habel, PhD; Michael
Pollak, MD; Judith G. Regensteiner, PhD; Douglas Yee, MD. Diabetes Care,
Published Online: June 16, 2010; Print Issue Date: July 2010.

Diabetes Care, published by the American Diabetes Association, is the
leading peer-reviewed journal of clinical research into one of the
nation’s leading causes of death by disease. Diabetes also is a leading
cause of heart disease and stroke, as well as the leading cause of adult
blindness, kidney failure, and non-traumatic amputations.

The American Diabetes Association is leading the fight to stop diabetes
and its deadly consequences and fighting for those affected by diabetes.
The Association funds research to prevent, cure and manage diabetes;
delivers services to hundreds of communities; provides objective and
credible information; and gives voice to those denied their rights
because of diabetes. Founded in 1940, our mission is to prevent and cure
diabetes and to improve the lives of all people affected by diabetes. For
more information please call the American Diabetes Association at
1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information
from both these sources is available in English and Spanish.

Contact:
Dayle Kern
(703) 549-1500 ext. 2290
dkern@diabetes.org

Copyright 2010, Market Wire, All rights reserved.

For a healthier heart replace saturated fat with polyunsaturated fatty acids

Washington, March 23 (ANI): Replacing saturated fat with polyunsaturated fatty acids is good for the heart, a new American research has revealed.

The study has appeared in PLoS Medicine.

Dariush Mozaffarian and colleagues from Harvard Medical School and Harvard School of Public Health conducted a systematic review and meta-analysis of randomised controlled trials studying the effects on coronary heart disease of increasing polyunsaturated fat in place of saturated fat.

They reviewed 8 trials involving over 13,000 participants and found that among those substituting SFA for PUFA (the intervention group), there was a 19 percent reduced risk of CHD risk compared to participants in the control groups. The consumption of PUFA accounted for 15percent of total energy intake in the intervention groups on average but only 5 percent of total energy intake in the control groups. As such, the researchers report that each 5 percent increase in the proportion of energy obtained from PUFA reduced the CHD risk by 10percent.

Moreover, they found that the benefits associated with PUFA consumption increased with greater duration of the trials.

While reducing consumption of saturated fat (contained in meat, cheese, and butter, for example) is recommended as a way to prevent CHD, recent large meta-analyses of observational studies have suggested no overall benefits of reducing SFA consumption on CHD events.

Few clinical studies have examined the effects on CHD events of replacing saturated fat in the diet with specific alternative energy sources like carbohydrate, protein, or other types of fat such as polyunsaturated fats, which include vegetable oils.

In fact, some experts argue that eating PUFA actually increases CHD risk and some guidelines recommend PUFA consumption should be limited. As a result, there has been a strong need for more scientific study.

The authors say: “Rather than trying to lower PUFA consumption…a shift toward greater population PUFA consumption in place of SFA could significantly reduce rates of CHD.” (ANI)

It’s official: Steaming cup of morning coffee helps you stay fit

Washington, Mar 16 (ANI): A steaming hot cup of coffee in the morning can actually do wonders for your health.

And now two new studies have provided more support to the drink’s benefits.

Touted as “the devil”s brew,” coffee contains several nutrients (eg, calcium) as well as hundreds of potentially biologically active compounds (eg, polyphenols) that may promote health.

For instance, observational studies have suggested a beneficial link between coffee consumption and type 2 diabetes.

Two studies have lent additional information concerning the potential health benefits of coffee.

These studies provide additional support for the emerging health benefits of coffee.

Rigorous clinical intervention trials will be needed to understand more fully the biological mechanisms.

The studies by Kempf and Sartorelli “add to a growing literature suggesting that my steaming cup of morning coffee might help me stay healthy,” said ASN Spokesperson Dr. Shelley McGuire.

“I”m a research scientist, but I still trust that foods and beverages which have been part of our culture for generations are probably good for us, or at least they”re probably not bad for us in moderation! Of particular interest is the well-controlled clinical trial that suggests coffee can lower chronic inflammation and even raise our ”good” cholesterol. I for one will enjoy my coffee even more in the weeks to come,” she added.

The studies have been published in the April 2010 issue of The American Journal of Clinical Nutrition report. (ANI)

Aspirin ‘cuts colorectal cancer death risk’

Washington, Aug 12 (ANI): Taking aspirin on a regular basis after being diagnosed with colon cancer has been found to reduce the chances of dying from the disease, reveals a new study.

Numerous prospective, observational studies have shown that regular aspirin use is linked to a lower risk of colorectal adenoma (a benign tumour) or cancer.

However, the influence of aspirin on survival after diagnosis of colorectal cancer has been unknown.

Dr. Andrew Chan of Massachusetts General Hospital and Harvard Medical School in Boston and colleagues studied aspirin use in 1,279 men and women with colorectal cancer that had not spread to other parts of the body.

They found that people who took aspirin regularly after their diagnosis were nearly 29 percent less likely to die from their cancer than people who did not take aspirin. These people also were 21 percent less likely to die for any reason while they were in the study lasting more than two decades.

“These results suggest that aspirin may influence the biology of established colorectal tumours in addition to preventing their occurrence,” Chan said.

Aspirin is likely, at least in part, to prevent colorectal neoplasia (tumour growth) through inhibition of cyclooxygenase-2 (COX-2; an enzyme), which promotes inflammation and cell proliferation, and is overexpressed in the majority of human colorectal cancers, according to background information in the article.

The study has been published in the August 12 issue of JAMA. (ANI)

Pacifiers don’t interfere with breastfeeding success

Washington, Apr 30 (ANI): Giving an infant a pacifier does not interfere with breastfeeding success, say researchers.

The team led by Dr Fern Hauck, researcher and associate professor of family medicine and public health sciences at the University of Virginia School of Medicine has found no adverse relationship between the two.

“Physicians, nurses and others who advise parents on infant care issues do need to be educated about the potential benefit of using a pacifier for Sudden Infant Death Syndrome (SIDS) prevention, and further, now need to be reassured that using the pacifier should not interfere with breastfeeding,” said Hauck.

The researchers reviewed 29 studies, of which four were randomized control studies (RCT), 20 were cohort studies and five were cross sectional studies.

The results from the four RCTs showed no difference in breastfeeding outcomes with different pacifier interventions, such as use with tube feedings, use after delivery or educational programs promoting non-use of pacifiers.

Most of the observational studies- cross-sectional and cohort – reported an association between pacifier use and shortened duration of breastfeeding.

According to Hauck, this association was likely due to other factors such as breastfeeding difficulties or desire to wean.

“Mothers who breastfeed are often advised not to use a pacifier. This recommendation needs to be corrected. However, if a baby refuses a pacifier, it should not be forced upon him or her,” she said.

Hauck added that the best time to introduce a pacifier is usually when the baby is three to four weeks old, after breastfeeding is well established. Most of all, mothers who choose to breast-feed need lots of support.

The results appear in Archives of Pediatric Adolescent Medicine. (ANI)

No link between osteoporosis drugs, irregular heartbeat

Washington, Apr 7 (ANI): Commonly used osteoporosis drugs have not been found to increase the risk of irregular heartbeat, say research team led by Indian-origin scientist from Wake Forest University School of Medicine.

Bisphosphonates, found in prescription drugs reduces the risk of fractures, especially those of the spine and hips in older patients, however studies have revealed that they might cause problems with heart rhythm, thereby increasing the risk of stroke or heart attack.

“Some trials show there could be a potential link between the use of bisphosphonates and the development of serious heart rhythm problems, but in our study the link wasn’t conclusive,” said Sonal Singh from Wake Forest University School of Medicine and lead investigator for the study.

“So we urge that additional investigations be conducted,” she added.

During the study, the researchers analyzed the data from previous observational studies and clinical trials to determine the link between bisphosphonate therapy and irregular heart beat.

Although bisphosphonate use was associated with a significant increase in the incidence of “serious” heart rhythm disturbances, but when they included “non-serious” cases in their analysis, they found no overall increased risk of atrial fibrillation.

“We found no risk of stroke and cardiovascular mortality in the trials. That was very reassuring,” said Singh.

The study appears in Drug Safety. (ANI)

Adequate intake of vitamin D can prevent diabetes

Washington, January 13 (ANI): Diabetes can be prevented, and the disease’s complications for those diagnosed with it reduced, through adequate intake of vitamin D, says a report.

The review article by researchers from Loyola University Chicago Marcella Niehoff School of Nursing appears in the latest issue of Diabetes Educator.

“Vitamin D has widespread benefits for our health and certain chronic diseases in particular. This article further substantiates the role of this nutrient in the prevention and management of glucose intolerance and diabetes,” said Sue Penckofer, Ph.D., R.N., study co-author and professor, Loyola University Chicago Marcella Niehoff School of Nursing.

The report’s authors revealed that one of the studies they reviewed evaluated 3,000 people with type 1 diabetes, and found a decreased risk in disease for people who took vitamin D supplements.

They further said that observational studies of people with type 2 diabetes also revealed that supplementation might be important in the prevention of this disease.

“Management of vitamin D deficiency may be a simple and cost-effective method to improve blood sugar control and prevent the serious complications associated with diabetes,” said Joanne Kouba, Ph.D., R.D., L.D.N., study co-author and clinical assistant professor of dietetics, Loyola University Chicago Marcella Niehoff School of Nursing.

According to the researchers, diet alone might not be sufficient to manage vitamin D levels, and that a combination of adequate dietary intake of vitamin D, exposure to sunlight and treatment with vitamin D2 or D3 supplements could decrease the risk of diabetes and related health concerns.

The preferred range in the body is 30 – 60 ng/mL of 25(OH) vitamin D, they say.

“People at risk for diabetes should be screened for low vitamin D levels. This will allow health care professionals to identify a nutrient deficiency early on and intervene to improve the long term health of these individuals,” said Mary Ann Emanuele, M.D., F.A.C.P., study co-author and professor of medicine, division of endocrinology and metabolism, Loyola University Health System.

The reviewers have noted in their report that vitamin D deficiency might also be associated with hyperglycemia, insulin resistance, hypertension, and heart disease. (ANI)