The drug, called alogliptin or SYR-322, is critical to Takeda’s mainstay diabetes business as it is expected to be the main replacement for its best-selling Actos.

Actos, which generates almost 30 percent of Takeda’s sales, will lose U.S. patent protection in 2011.

The U.S. Food and Drug Administration did not ask for more information on alogliptin, raise any issues with data or provide any guidance on when a review might be completed, a Takeda spokeswoman said.

The review had been scheduled to finish on Oct. 27.

Last month, the FDA also failed to complete a review of Eli Lilly and Co (LLY.N: Quote, Profile, Research, Stock Buzz) and Daiichi Sankyo Co Ltd’s (4568.T: Quote, Profile, Research, Stock Buzz) closely watched anti-clotting drug prasugrel.

Industry analysts have said the prasugrel delay was most likely due to a backlog at the FDA or perhaps small issues with the labelling.

Alogliptin belongs to a new class of diabetes drugs called DPP-4 inhibitors, and Takeda hopes it will compete with rival drug Januvia from Merck & Co (MRK.N: Quote, Profile, Research, Stock Buzz).

Takeda has also sought U.S. approval for an alogliptin-Actos combination pill. (Reporting by Sachi Izumi; Editing by Edwina Gibbs)

Japan´s biggest drugmaker Takeda Pharmaceutical Co has stated the U.S. health authorities´ review on their experimental diabetes drug alogliptin or SYR-322, scheduled to finish on October 27th and critical to Takeda as their main replacement for best-selling Actos, is not on schedule due to a lack of resources.

Diabetes drug Actos, with sales in Japan´s first quarter 2008 of $ 958 million dollars (yearly sales of some $ 3 billion dollars, almost 30 percent of Takeda´s income) will lose U.S. patent protection in 2011.

The U.S. Food and Drug Administration (FDA) did not ask for more information on alogliptin, raise any issues with data or provide any guidance on when a review – submitted on January 4th, 2008 - might be completed, a Takeda spokeswoman said.

Last month, the FDA also failed to complete a review of Eli Lilly & Co and Daiichi Sankyo Co Ltd´s anti-clotting drug prasugrel, which industry analysts have said was most likely due to a backlog at the FDA, or small issues with the labeling.

Alogliptin-SYR-322 belongs to a new class of diabetes drugs called DPP-4 inhibitors, and if approved, would be competing with Merck & Co´s Januvia ($ 606 million dollars in 1H2008), the only DPP-4 inhibitor approved for marketing in the U.S.

Submitted in July 2008 and under review by the FDA and Europe´s regulating agency EMEA is Bristol-Myers Squibb/AstraZeneca´s experimental diabetes DPP-4 inhibitor Onglyza.

Takeda has also sought U.S. approval for a combination alogliptin-Actos pill.

Among couples with a partner of each race, 4% of the women developed gestational diabetes, compared with 1.6% of women in white couples and 5.7% of Asian couples. Gestational diabetes is a “known risk factor” for Asian couples and “thought to be linked to a genetic predisposition,” according to the Los Angeles Times. Researchers found that couples with one Asian partner and one white partner had an increased risk for the disease regardless of which partner was Asian.

Researchers also found that 33% of Asian women who had a white partner had a caesarean, compared with 23% of couples where the woman was white and the man was Asian. The higher rate of c-sections “is thought to be linked to body type,” because Asian women tend to have smaller pelvises than white women, the Times reports (Roan, Los Angeles Times, 10/1).

Researchers said, “Our study demonstrates that interracial Asian-Caucasian couples represent a population with distinct perinatal risks, with differing risks depending upon which parent is of Asian race,” adding, “Further research into interracial couples may she[d] light onto the effects of genetics [versus] environment on perinatal outcomes” (Reuters Health, 10/1).

Opinion Piece
The results of the study show that “[w]hile it’s great to be colorblind at cocktail parties and at the ballot box, women and their doctors should be talking about race and ethnicity,” Deborah Kotz, senior editor for U.S. News & World Report, writes in the “On Women” blog, adding that “[m]ore research certainly is warranted.”

Kotz says that the findings on gestational diabetes are “intriguing,” noting that researchers are considering additional studies to determine whether pregnant Asian women should undergo earlier screenings for gestational diabetes than other pregnant women. She also notes research looking at differences in breast cancers among black women who are descendents from different parts of Africa.

Kotz writes, “Focusing on someone’s race or ethnicity, whether in politics or social settings, is widely frowned upon these days — a very good thing,” adding, “In medicine, though, your ethnic background can play a crucial role in determining certain health risks” (Kotz, “On Women,” U.S. News & World Report, 10/1).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

Couples made up of one Asian and one white partner may face an increased risk of gestational diabetes and a higher risk of Caesarean delivery, say researchers at the Lucile Packard Children’s Hospital and the Stanford University School of Medicine.

In a study published in the October issue of theAmerican Journal of Obstetrics & Gynecology, researchers looked at data from white, Asian, and Asian-white couples who delivered at the Johnson Center for Pregnancy and Newborn Services at Packard Children’s from 2000 to 2005. During that time, 5,575 white, 3,226 Asian, and 868 Asian-white couples delivered babies at the hospital.

“There’s great heterogeneity in our country; there are people of many different races and backgrounds,” co-author Yasser El-Sayed, an obstetrician at Packard Children’s and an associate professor of obstetrics and gynecology at the medical school, said in a Stanford news release. “Gaining better insight into the risks facing specific populations provides for better counseling and better prenatal care.”
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The researchers found that white mothers whose partners were Asian fathers had the lowest rate — 23 percent — of Caesarean delivery. Asian mother/white father couples, on the other hand, had the highest rate, with 33 percent of pregnancies resulting in Caesarean deliveries.

The reason for the discrepancy? The researchers say that since the birth weights between the two groups is similar, the increased rate of Caesarean deliveries among Asian mother/white couples may be because the average Asian woman’s pelvis is smaller than the average white woman’s pelvis. Therefore, Asian women may be less likely to be able to accommodate babies of a certain size.

The researchers also found that the rate of gestational diabetes was lowest among white couples (1.6 percent) and highest among Asian couples (5.7 percent). For Asian-white couples, the rate of gestational diabetes was just under 4 percent.

Previous studies have found an increased risk of diabetes among Asian couples, which has been attributed to genetics. The results of this study are particularly interesting, since the risk of gestational diabetes was about the same regardless of which person was Asian.

These findings are important for health-care professionals who are counseling women about their pregnancy risks, the researchers said.

“One has to factor in as many relevant variables as possible when you counsel a patient about pregnancy,” said El-Sayed. “We’ve shown in this paper that if you have an interracial couple, depending on which parent is of which race, there may be different relative risks of certain outcomes that could inform and enhance clinical management.”

Two out of three people with diabetes die of a heart attack or stroke, so reducing cardiovascular disease is a priority. The study was in part funded by the Physicians Committee for Responsible Medicine, which promotes a vegan diet.

diabetes symptoms, hypoglycemia, type 2 diabetes, gestational diabetes, diabetes diet, type 1 diabetes, low blood sugar , glucose, insulin resistance, diabetic neuropathy, A1c, exercise and diabetes
© 2008 WebMD, LLC. All rights reserved.

For 22 weeks, participants followed either a low-fat, low-glycemic vegan diet or guidelines prescribed by the ADA. All 99 participants had type 2 diabetes. Both men and women participated and were recruited through a newspaper ad in the Washington, D.C., area.

Participants reported what they ate at the start of the trial and throughout the trial. Researchers took the data and calculated scores based on the Alternate Healthy Eating Index (AHEI). Scores were calculated at the beginning of the 22 weeks and again at the end. There was no difference in the scores between the two groups at the start of the study.

Past research has shown a correlation between AHEI and cardiovascular disease. The AHEI is a nine-component dietary index used to rate foods and macronutrients related to chronic disease risk. The higher the AHEI score, the lower the risk of cardiovascular disease. The vegan dieters saw significant improvements in their AHEI scores; the ADA group did not.

The vegan group improved significantly in every AHEI category, including increased intake of vegetables, fruits, nut and soy protein, and cereal fiber, and a decrease in trans fat intake.

Both groups were able to reduce their weight and their hemoglobin A1c, a measure of blood sugar levels over a prolonged period of time. However, the vegan group experienced more significant reductions in both categories.

“The results of this study suggest that, if followed for the long-term, a low-fat vegan diet may be associated with a reduced risk of major chronic diseases, particularly cardiovascular disease,” the study concludes.

Neither diet resulted in adequate intake of vitamins D or E, or of calcium. Patients attempting to follow either eating plan should consult with their doctor and make sure they are getting adequate amounts of these nutrients.

People with type 2 diabetes who need insulin to control their blood glucose levels can choose either human insulin or a structurally similar synthetic version to do the job, a study shows.

“There is no difference between premixed human insulin and premixed insulin analogues,” Dr. Rehan Qayyum from Johns Hopkins Hospital, Baltimore, told Reuters Health.

Qayyum and colleagues reviewed clinical studies of the effectiveness and safety of premixed insulin analogues compared with other anti-diabetes agents in adults with type 2 diabetes.

Premixed insulin analogues provided tighter glucose control than long-acting insulin and non-insulin agents, according to the investigators’ report in the Annals of Internal Medicine. Premixed insulin analogues were comparable to premixed human insulin in lowering A1C levels, an indicator of relatively long-term glucose control.

The occurrence of episodes of too-low glucose levels, i.e., hypoglycemia, was similar with premixed insulin analogues and with premixed human insulin.

“I have found in my previous comparative research that the benefits of new treatments and interventions are often exaggerated by industry and academia (unfortunately),” Qayyum added.

“Studies with longer follow-up are needed to determine whether the effects observed early in treatment are sustainable long-term,” the team concludes.

SOURCE: Annals of Internal Medicine, online September 15, 2008

CAUSES: Developing type 2 diabetes is a gradual process, but most people with the disease are overweight at the point of diagnosis. Family history and genetics also influence your risk for developing this type of diabetes. Low activity level, poor diet and excess body weight, especially around the waist, significantly increase your risk for type 2 diabetes, according to the National Institutes of Health. Other risk factors for the disease include race/ethnicity, age of over 45 years, previously identified impaired glucose tolerance, HDL cholesterol of less than 35 mg/dL or triglyceride level of greater than 250 mg/dL, a history of gestational diabetes and high blood pressure. Type 2 diabetes is more common in African Americans, Latinos, Native Americans and Asian Americans/Pacific Islanders, as well as the elderly population.

PREVENTION: This disease can usually be prevented by lifestyle modifications. The Harvard School of Public Health recommends five ways to prevent Type 2 diabetes. They say exercising regularly, maintaining a healthy weight, choosing healthy fats like olive oil and avocados, eating a lot of whole grains and cutting back on refined carbohydrates and sugary drinks can prevent most cases of the disease. Another way to prevent diabetes is by watching for symptoms. Having your blood glucose checked every three years after turning 45 is a good was to do this.

TREATMENT: Stabilizing your blood glucose levels helps prevent symptoms, complications and further damage to your body. The first way to do this is by exercising regularly and eating a healthy diet to maintain a healthy weight. If you have diabetes and are taking insulin or diabetes pills, on intensive insulin therapy, pregnant, having a hard time controlling your blood glucose levels, having severe low blood glucose levels or ketones from high blood glucose levels, or having low blood glucose levels without the usual warning signs, the American Diabetes Association recommends you regularly check your blood glucose. Tests are usually done before meals and at bedtime and with a blood glucose meter.

A DRUG THAT REDUCES BLOOD SUGAR: Salsalate is a nonsteroidal anti-inflammatory medication currently prescribed to relieve pain, tenderness, swelling and stiffness caused by rheumatoid arthritis, osteoarthritis and other conditions that cause swelling. The drug works by stopping the body’s production of a substance that causes pain, fever and swelling.

A study published in Diabetes Care in February 2008 showed salsalate lowered blood sugar and reduced inflammation in obese young adults. Researchers concluded this shows promise for preventing diabetes with the medication in the future. Researchers returned to the topic of salsalate and diabetes in a paper published a few months later in which they proposed salsalate may be used to treat diabetes for the same reasons.

Amidst a growing number of children who are being diagnosed with diabetes and the high number of Hispanics in San Antonio who have the disease, Por tu Familia’s 2nd Annual Conferencia: La Diabetes y la Nutricion, presented by the American Diabetes Association will do everything it can to attract families on the West Side.

The second annual conference will be from 9 a.m.-1:30 p.m. on Sept. 27 at the Avenida Guadalupe Plaza and Progreso Center, 1327 Guadalupe St.

In addition to a health fair that will provide health screenings, the free conference will host nutrition education workshops and will give away cookbooks to the first 200 people.

Courtney Crisler, associate director of programs for the local chapter of the American Diabetes Association, said the event is geared toward Hispanics of all ages, but this year’s event will have special programs for children, including a petting zoo.

This is something families can do together and is not age specific, Crisler said.

San Antonio has one of the highest rates of diabetes in the country. Nationwide, the average of people who have it is 7 percent, here 14 percent of San Antonians have it, including 80,000 Hispanics.

The area surrounding the Avenida Guadalupe Plaza has the highest rate of diabetes in the city, Crisler said.

“The need for diabetes education (in the area) is very important,” she added.

The seminars presented at the conference will be interactive and bilingual and will touch on culturally appropriate lifestyle choices. Exhibitors, including healthcare providers, retailers, restaurants and other food product vendors will be on hand to distribute information to attendees.

Event organizers are expecting between 300-500 attendees. Crisler said she hopes that families can not only take part in this event together, but also take what they learned home to other family members who couldn’t attend.

For more information contact the American Diabetes Association at (210) 829-1765

During pregnancy it is important that women with diabetes keep their blood glucose under control. If not, there may be an increase in the amount of glucose reaching the baby, which makes the baby grow faster than normal, and may cause difficulties at birth as well as an increased longer term risk of insulin resistance, obesity and type 2 diabetes.

Evidence suggests that measuring glucose more often improves outcomes, but the optimum frequency of blood glucose testing is not known.

Dr Helen Murphy and colleagues examined whether continuous glucose monitoring during pregnancy can improve maternal glucose control and reduce birth weight and risk of macrosomia in babies of mothers with diabetes.

They recruited 71 pregnant women with type 1 and type 2 diabetes from antenatal clinics in the UK.

The women were randomly assigned to standard antenatal care (intermittent self monitoring of glucose levels using the finger prick technique) or intermittent monitoring plus continuous glucose monitoring (using glucose values from subcutaneous tissues measured electronically every 10 seconds, giving up to 288 measurements a day).

Continuous glucose monitoring was used as a tool to aid patient education and optimise lifestyle and therapeutic management of blood glucose levels.

The researchers found that women in the continuous glucose monitoring group had lower mean levels of HbA1c (a measure of the amount of glucose attached to red blood cells) from 32 to 36 weeks’ gestation, and improved blood glucose control during the third trimester, compared to women receiving standard antenatal care.

Babies of mothers who had continuous monitoring also had lower birth weight and reduced risk of macrosomia.

But because macrosomia rates were still 3.5 times higher in women using continuous glucose monitoring than in the general maternity population it shows that standard interventions including diet and insulin have failed to reduce rates of macrosomia enough, say the authors. This emphasises the need for novel educational and technological interventions especially in women with long duration type 1 diabetes, they add.

This trial provides evidence of the lasting benefits of continuous monitoring for the babies of mothers with diabetes and is a potentially important target for public health strategies that aim to reduce the burden of obesity in childhood, say the authors.

In an accompanying editorial, Professor Mario Festin says that continuous glucose monitoring increases the consistency and accuracy of glucose measurement which is vital for the nutritional and drug management of diabetes in pregnancy.

Continuous glucose monitoring is relatively cheap compared with a clinic based monitoring system and more widespread use may make it more affordable even in developing countries, he concludes.

*Macrosomia or big baby syndrome refers to babies with a birth weight above the 90th percentile (the weight above which you expect only 10% of babies to be born) and it is the commonest complication of pregnancy in women with diabetes.

BISMARCK, N.D —  A dramatic rise in the number of North Dakota children with Type 2 diabetes — a form of diabetes normally seen in adults — provides more evidence of a link between the disease and childhood obesity, experts say.

The likely connection between an increase in obesity and Type 2 diabetes in children and adolescents has come to light only in the past decade, and officials still are working to compile nationwide trend data and study the best ways to treat youth with Type 2.

Elizabeth Mayer-Davis at the University of North Carolina, a lead investigator of an ongoing national study on Type 2 diabetes in children, said the North Dakota data highlight the need to combat childhood obesity, which some are calling a modern-day epidemic.

“Obesity … almost certainly plays a major role,” Mayer-Davis said. Other unknown factors might also be in play, she said.

Type 2 diabetes, which stems from the body’s failure to properly use insulin, typically is seen in people middle-age and older, said Sherri Paxon, director of the North Dakota Health Department’s chronic disease division.

A study released earlier this fall that was coordinated by the department and Blue Cross Blue Shield of North Dakota found a large increase in the prevalence of childhood diabetes in North Dakota over a five-year period — from 2.8 per 1,000 youth age 18 and younger in 2003 to 4.5 per 1,000 in 2007. The estimated percentage of children with Type 2 diabetes — based on whether children had pharmacy claims of insulin — went from 23 percent to 31 percent in those years.

“I think science right now is pointing us to a lack of physical activity and poor nutrition, which leads to being overweight, as a primary cause of Type 2 diabetes” in youth, Paxon said.

David Hanekom, the medical director for Blue Cross Blue Shield, said adults must “step up to the plate” and deal with the problem.

“Really, it’s a societal issue,” he said. “It’s not something the medical community can deal with. The medical community deals with the complications and effects.”

The North Dakota study was possible because of cooperation between the state Health Department and Blue Cross Blue Shield, which covers the majority of the state’s insured children. It did not calculate prevalence rates for Type 2 diabetes, only percentages.

Judith Fradkin, a division director at the National Institutes of Health, said Type 2 diabetes in children is a problem of the 21st century.

“Pediatricians, endocrinologists … they were just telling us they were starting to see all these kids with Type 2 diabetes,” she said.

“Almost all kids with Type 2 are obese or overweight (and) most are obese,” she said.

The Centers for Disease Control and Prevention says childhood obesity has reached epidemic levels. The agency says the prevalence of obesity among children ages 6 to 11 has more than doubled since the 1960s.

“We know in adults that obesity is the major risk factor for diabetes,” said Giueseppina Imperatore, a diabetes expert at the CDC. “We definitely think it is also the case in children.”

Imperatore and Fradkin said an unborn child also has a greater risk of getting Type 2 diabetes if the pregnant mother has the disease.

“Essentially, it is a disease of reproductive age. Before, you got it later in life,” Imperatore said.

A number of studies dealing with children and Type 2 diabetes are under way. Francine Kaufman, head of the diabetes center at Children’s Hospital in Los Angeles, is heading a National Institutes of Health study on the best way to treat Type 2 diabetes in young people. The NIH and CDC are funding a study on the rates of Type 2 diabetes in children, and another national study is looking at the effects of changes in food service and physical education at 42 middle schools around the country.

The NIH and Indian Health Service are getting ready to launch a new curriculum for American Indian students to better educate them about diabetes and encourage some to pursue health-related fields, Kaufman said.

Researchers say minority children are more susceptible to Type 2 diabetes, and Fradkin says their environment is a factor.

For example, she said, children on American Indian reservations might not have easy access to stores with healthy food choices such as fresh fruits and vegetables, and minority children in the inner-city neighborhoods of urban centers might be kept indoors by parents who fear for their safety.

The results of the North Dakota study were not broken down by race, though Hanekom said he does not believe North Dakota’s population of American Indians skewed the results. Blue Cross Blue Shield estimated only about 2 percent of its members are Indian.

Experts say changing people’s attitudes is key to reducing the rate of diabetes. Many environmental factors can be changed, such as the amount of time children spend watching TV and playing video games. Fradkin said one study found people at high risk for the disease reduced their risk by nearly 60 percent by losing about 15 pounds.

“You don’t have to become a marathon runner or have a model-size figure,” she said. “Just making some small changes — losing 15 pounds — has just a huge effect on reducing diabetes.”

Hanekom said reducing Type 2 diabetes in children will take more than just telling them to exercise.

“You can’t just tell a child, ‘eat less, move more,”‘ he said. “The way to address obesity would be the same way we address smoking — multiprong, legislation, attitude changes, etc.

“If our children are our future, then we have an issue,” Hanekom said. “It’s not going to go away unless there are some radical changes in the environment we bring kids up in.”

A dramatic rise in the number of North Dakota children with Type 2 diabetes — a form of diabetes normally seen in adults — provides more evidence of a link between the disease and childhood obesity, experts say.

The likely connection between an increase in obesity and Type 2 diabetes in children and adolescents has come to light only in the past decade, and officials still are working to compile nationwide trend data and study the best ways to treat youth with Type 2.

Elizabeth Mayer-Davis at the University of North Carolina, a lead investigator of an ongoing national study on Type 2 diabetes in children, said the North Dakota data highlight the need to combat childhood obesity, which some are calling a modern-day epidemic.

“Obesity … almost certainly plays a major role,” Mayer-Davis said. Other unknown factors might also be in play, she said.

Type 2 diabetes, which stems from the body’s failure to properly use insulin, typically is seen in people middle-age and older, said Sherri Paxon, director of the North Dakota Health Department’s chronic disease division.

A study released earlier this fall that was coordinated by the department and Blue Cross Blue Shield of North Dakota found a large increase in the prevalence of childhood diabetes in North Dakota over a five-year period — from 2.8 per 1,000 youth age 18 and younger in 2003 to 4.5 per 1,000 in 2007. The estimated percentage of children with Type 2 diabetes — based on whether children had pharmacy claims of insulin — went from 23 percent to 31 percent in those years.

“I think science right now is pointing us to a lack of physical activity and poor nutrition, which leads to being overweight, as a primary cause of Type 2 diabetes” in youth, Paxon said.

David Hanekom, the medical director for Blue Cross Blue Shield, said adults must “step up to the plate” and deal with the problem.

“Really, it’s a societal issue,” he said. “It’s not something the medical community can deal with. The medical community deals with the complications and effects.”

The North Dakota study was possible because of cooperation between the state Health Department and Blue Cross Blue Shield, which covers the majority of the state’s insured children. It did not calculate prevalence rates for Type 2 diabetes, only percentages.

Judith Fradkin, a division director at the National Institutes of Health, said Type 2 diabetes in children is a problem of the 21st century.

“Pediatricians, endocrinologists … they were just telling us they were starting to see all these kids with Type 2 diabetes,” she said.

“Almost all kids with Type 2 are obese or overweight (and) most are obese,” she said.

The Centers for Disease Control and Prevention says childhood obesity has reached epidemic levels. The agency says the prevalence of obesity among children ages 6 to 11 has more than doubled since the 1960s.

“We know in adults that obesity is the major risk factor for diabetes,” said Giueseppina Imperatore, a diabetes expert at the CDC. “We definitely think it is also the case in children.”

Imperatore and Fradkin said an unborn child also has a greater risk of getting Type 2 diabetes if the pregnant mother has the disease.

“Essentially, it is a disease of reproductive age. Before, you got it later in life,” Imperatore said.

A number of studies dealing with children and Type 2 diabetes are under way. Francine Kaufman, head of the diabetes center at Children’s Hospital in Los Angeles, is heading a National Institutes of Health study on the best way to treat Type 2 diabetes in young people. The NIH and CDC are funding a study on the rates of Type 2 diabetes in children, and another national study is looking at the effects of changes in food service and physical education at 42 middle schools around the country.

The NIH and Indian Health Service are getting ready to launch a new curriculum for American Indian students to better educate them about diabetes and encourage some to pursue health-related fields, Kaufman said.

Researchers say minority children are more susceptible to Type 2 diabetes, and Fradkin says their environment is a factor.

For example, she said, children on American Indian reservations might not have easy access to stores with healthy food choices such as fresh fruits and vegetables, and minority children in the inner-city neighborhoods of urban centers might be kept indoors by parents who fear for their safety.

The results of the North Dakota study were not broken down by race, though Hanekom said he does not believe North Dakota’s population of American Indians skewed the results. Blue Cross Blue Shield estimated only about 2 percent of its members are Indian.

Experts say changing people’s attitudes is key to reducing the rate of diabetes. Many environmental factors can be changed, such as the amount of time children spend watching TV and playing video games. Fradkin said one study found people at high risk for the disease reduced their risk by nearly 60 percent by losing about 15 pounds.

“You don’t have to become a marathon runner or have a model-size figure,” she said. “Just making some small changes — losing 15 pounds — has just a huge effect on reducing diabetes.”

Hanekom said reducing Type 2 diabetes in children will take more than just telling them to exercise.

“You can’t just tell a child, ‘eat less, move more,”‘ he said. “The way to address obesity would be the same way we address smoking — multiprong, legislation, attitude changes, etc.

“If our children are our future, then we have an issue,” Hanekom said. “It’s not going to go away unless there are some radical changes in the environment we bring kids up in.”

The FDA has not yet approved liraglutide, although the new findings make eventual approval seem likely. Liraglutide requires once-daily injections. Byetta requires two injections a day, although a once-weekly version is in the works.

Liraglutide and Byetta are analogs of a hormone called GLP-1, which stimulates insulin secretion and expands insulin-making beta cells in the pancreas. A related class of diabetes drugs, the DPP-4 inhibitors, blocks an enzyme that degrades GLP-1. DPP-4 inhibitors include Januvia, approved in the U.S. and Europe, and Galvus, approved in Europe but not in the U.S.

It’s not clear whether liraglutide will have the same rare-but-dangerous side effect of pancreatitis seen with Byetta — although two such cases have been reported in patients receiving liraglutide. Both drugs can cause nausea, vomiting, and diarrhea, although these side effects tend to go away after the first month of treatment.

A downside to the DPP-4 inhibitors is that because DPP-4 plays a role in immunity, patients taking these drugs appear to have an increased risk of infections.

The new study, by Baylor College of Medicine researcher Alan Garber, MD, PhD, and colleagues, did not compare liraglutide directly to Byetta or DPP inhibitors. Instead, the study compared liraglutide to Amaryl, a member of the commonly used class of drugs called sulfonylureas, which stimulate insulin secretion.

In the study, 746 patients with early type 2 diabetes received once-daily 1.2 mg or 1.8 mg doses of liraglutide by injection or once daily Amaryl by oral tablet. Patients getting liraglutide received dummy pills; those getting Amaryl received injections of a harmless, inactive placebo.

Before treatment, patients’ HbA1c scores — a measure of long-term blood-sugar control — ranged from 7% to 11%. After 52 weeks of treatment:

* HbA1c dropped 1.14% in patients receiving 1.8 mg doses of liraglutide.
* HbA1c dropped 0.84% in patients receiving 1.2 mg doses of liraglutide.
* HbA1c dropped 0.51% in patients receiving Amaryl.
* 51% of patients getting 1.8 mg doses of liraglutide reached the American Diabetes Association target HbA1c level of less than 7.0%.
* 43% of patients getting 1.2 mg doses of liraglutide reached the ADA target HbA1c level.
* 28% of patients getting Amaryl reached the ADA target HbA1c level.

Patients treated with liraglutide lost weight, while most of those treated with Amaryl gained weight. Weight loss over the first 16 weeks of the study was maintained at the one-year mark.

Patients who had nausea for more than seven days lost 7.1 pounds on the 1.2 mg dose of liraglutide, 7.5 pounds on the 1.8 mg dose of liraglutide, and 3.15 pounds on Amaryl.

Patients who had no nausea, or nausea for up to seven days, lost 4.1 pounds on the 1.2 mg dose of liraglutide, lost five pounds on the 1.8 mg dose of liraglutide, and gained 2.7 pounds on Amaryl.

Liraglutide also reduced patients’ blood pressure more than Amaryl did.

While nausea was a common side effect of liraglutide, only six liraglutide patients dropped out of the study because of vomiting.

“We conclude that liraglutide is safe and effective as initial pharmacological therapy for type 2 diabetes mellitus and has advantages over other drugs used in monotherapy, such as greater reductions in weight, the number of [too-high-blood-sugar] events, and systolic blood pressure,” Garber and colleagues conclude.

The findings appear in the Sept. 25 online edition of The Lancet. The study was funded by liraglutide maker Novo Nordisk. Garber has received research grants from the company (as have several other study authors) and serves as an advisory board member. Two of the study authors are Novo Nordisk employees. The researchers had full access to the study data and claim final responsibility for the decision to submit the findings for publication.

Researchers in Britain have carried out the study and found that a lack of exposure to bacteria and viruses during childhood may lead to an increased chance of high blood sugar and related diseases.

In fact, according to them, exposure to some forms of “friendly” bacteria prevents the onset of type 1 diabetes, which often develops in childhood, where the immune system launches an attack on cells that produce insulin.

They came to the conclusion after carrying out an experiment on genetically-modified mice that lacked the part of the immune system which responded to bacteria, the Daily Mail reported.

The researchers found that 80 per cent of the mice raised in a completely germ-free environment, and therefore lacking “friendly” gut bacteria, developed severe diabetes.

However, when they gave the mice a cocktail of the usual bacteria found in the gut, the incidence of diabetes fell dramatically — the results are published in the latest edition of the Nature journal.

“Understanding the relationship between our gut flora and our immune system is extremely important. The objective now is to identify which friendly bacteria are having this effect, and how they stop the development of type 1 diabetes,” lead researcher prof. Susan Wong of Bristol University said.

However, the findings does not relate to type 2 diabetes, the much more common form of the disease linked to obesity and lifestyle.

Takeda Pharmaceutical Co (4502.T: Quote, Profile, Research, Stock Buzz) said on Wednesday it had applied for approval to market in the United States the SYR-322 and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes.

Takeda is currently waiting for U.S. approval of the SYR-322, a successor candidate for its best-selling Actos which will lose patent protection in the world’s largest drug market in 2011.

“It is the world’s first drug combining alogliptin (the generic name of SYR-322) and pioglitazone (the generic name of Actos). We see this providing us with a major foothold in coping with the impact of the patent expiry for Actos,” said Takeda spokeswoman Ayako Iwamuro.

Takeda made the application for the combination drug on Sept 19 and expects to receive approval in about 10 months at the earliest, she said.

Shares of Takeda ended the morning up 0.6 percent at 5,290 yen on the Tokyo Stock Exchange. (Reporting by Yumiko Nishitani; Editing by Hugh Lawson)

Diabetes research and awareness received a big boost thanks to a generous gift of more than $100,000 to the Juvenile Diabetes Research Foundation International (JDRF) raised by Thomas McInerney, owner and president of McInerney’s Woodhaven Chrysler Jeep.
McInerney’s son, James A. McInerney, suffered from the disease and had a fatal heart attack in January 2007. McInerney created the first annual Jimmy McInerney Memorial Golf Classic, held August 19th at the Cherry Creek Golf Club in Shelby Township, to raise money to combat diabetes. As a result of the inaugural event, McInerney presented a $100,000 check to the JDRF September 21.
“My wife, Jacqueline and I, along with Jimmy’s widow, Debbie and their daughter, Hayley, thought about how we could best pay tribute to our son and honor his memory,” McInerney said. “We’re delighted that we not only raised a lot of money, but raised awareness as well about diabetes.
“McInerney’s Woodhaven Chrysler Jeep has had a long history of supporting our hometown community, but this was a project that was close to home. We really understood the importance of reaching out to spread our message to as many people as possible.”
McInerney joined forces with the Juvenile Diabetes Research Foundation and together with the sponsors and volunteers, came up with the event — a day of golf, entertainment, auctions and guest speakers.
“Diabetes is a growing threat to our community and the McInerney’s help in raising funds gets us one step closer to a cure,” said Jim Slaughter, executive director of JDRF’s Southeast Michigan chapter. “Although focused on finding a cure for Type 1 diabetes, our research benefits both Type 1 and Type 2 diabetics — which combined effect an estimated 25 million Americans,” Slaughter adds.
The JDRF is the leading funder and advocate of Type 1 (juvenile) diabetes research worldwide. Type 1 Diabetes is a disease which strikes children and young adults suddenly and requires injections or infusion of insulin daily to stay alive. The disease can lead to kidney failure, blindness, heart disease, stroke and amputation. As many as 3 million people in the U.S. have Type 1 diabetes.
“We are already gearing up for next year’s event,” McInerney said. “Together, we think we can make some real progress in knocking out juvenile diabetes.”
About McInerney’s Woodhaven Chrysler Jeep: McInerney’s Woodhaven Chrysler Jeep is a member of the Chrysler Jeep Superstores Advertising Association. The Chrysler Jeep Superstores Advertising Association is a group of 39 independently owned Chrysler Jeep Superstores in Southeast Michigan from Monroe to Fowlerville and from Clinton to Port Huron.

In tests on mice, the bugs appeared to stop the rogue immune response that triggers the disease.

Type 1 diabetes is caused by an autoimmune response which destroys insulin-producing islet cells in the pancreas.

About 300,000 people in the UK suffer from the disease. The condition often develops in childhood and has to be controlled with daily insulin jabs.

Type 2 diabetes, the much more common form of the disease linked to obesity and lifestyle, affects almost two million Britons.

Scientists in the US studied genetically engineered diabetic mice whose immune systems lacked a key protein that allowed them to respond to bacteria.

Raised in a completely germ-free environment, 80% of the mice developed severe type 1 diabetes.

When they were given back a cocktail of the bacterial “flora” normally found in the mammalian gut, only around a third of the animals became ill.

The study showed that harmless bacteria could prevent type 1 diabetes even when there is a predisposition to the disease.

It also demonstrated the role played by the immune system protein MyD88 in type 1 diabetes.

Having good bacteria in the gut may help protect people from developing type one diabetes, new research shows.

Australian endocrinologists have welcomed the findings of a US study that supports the “hygiene hypothesis” that being too clean is not good for the health.

Researchers at the University of Chicago have shown that exposure to parasites, bacteria and viruses may help guard against allergies, asthma, and other disorders of the immune system.

In particular, tests on mice showed higher levels of good bacteria in the intestine may lower the severity of type one diabetes.

The results, published in the journal Nature, could explain why rates of the disease are rising fast in Australia and in other Western nations where society has becomes increasingly focused on sterility and cleanliness.

Professor Nikolai Petrovsky, director of endocrinology at Flinders Medical Centre in South Australia, said there was an important message about diet in the “exciting” new findings.

“This suggests that exposing young children to a diet rich in prebiotics, like inulin, and probiotics, like yoghurt and kefir, may help protect them against auto-immune diabetes,” Prof Petrovsky said.

He said it might also help explain why children who are breast fed have a much lower risk of type one diabetes than children fed on cow’s milk products.

“The take home message is that a healthy diet throughout life is critical to good health (and) the best diet for a newborn is natural mother’s milk,” Prof Petrovsky said.

“Following weaning, the diet should contain a high proportion of fibre and inulin rich foods, as found in many vegetables, ideally supplemented by a top-up regular dose of probiotics from eating naturally-fermented foods like yoghurt, kefir, and cheese.”

While this formed part of the recommended healthy diet, few people in the Western world were adhering to it, he said.

“It’s little wonder that we are seeing an explosion in obesity, diabetes, heart disease and the like,” the specialist said.

“It’s time to get back to basics.”

Diabetes is Australia’s fastest growing chronic disease, with about 100,000 people suffering from the type one form.

The findings, reported in the journal Nature, support the so-called “hygiene hypothesis” – the theory that a lack of exposure to parasites, bacteria and viruses in the developed world may lead to increased risk of diseases like allergies, asthma, and other disorders of the immune system.

The results also suggest that exposure to some forms of bacteria might actually help prevent onset of Type I diabetes, an autoimmune disease in which the patient’s immune system launches an attack on cells in the pancreas that produce insulin.

The root causes of autoimmune disease have been the subject of intensive investigation by scientists around the world.

In the past decade, it has become evident that the environment plays a role in the development of some overly robust immune system responses. For instance, people in less-developed parts of the world have a low rate of allergy, but when they move to developed countries the rate increases dramatically. Scientists have also noted the same phenomenon in their labs.

Non-obese diabetic (NOD) mice develop the disease at different rates after natural breeding, depending upon the environment where they are kept. Previous research has shown that NOD mice exposed to killed (i.e., non-active) strains of tuberculosis or other disease-causing bacteria are protected against the development of Type I diabetes. This suggests that the rapid “innate” immune response that normally protects us from infections can influence the onset of Type 1 diabetes.

In the Nature paper, teams led by Li Wen at Yale and Alexander V. Chervonsky at the University of Chicago showed that NOD mice deficient in innate immunity were protected from diabetes in normal conditions. However, if they were raised in a germ-free environment, lacking “friendly” gut bacteria, the mice developed severe diabetes. NOD mice exposed to harmless bacteria normally found in the human intestine were significantly less likely to develop diabetes, they reported.

“Understanding how gut bacteria work on the immune system to influence whether diabetes and other autoimmune diseases occurs is very important,” Li said. “This understanding may allow us to design ways to target the immune system through altering the balance of friendly gut bacteria and protect against diabetes.”

Changyun Hu from Yale also contributed to their research. Other institutions involved in the study were Washington University; The Jackson Laboratory, Bar Harbor, Me.; Bristol University, United Kingdom; and the University of California-San Francisco.

New research has indicated that good gut bacteria may be a factor in protecting against type 1 diabetes.

Researchers have found that higher levels of good bacteria in the intestine may lower the risk and severity of type 1 diabetes.

Diabetes is Australia’s fastest growing chronic disease, with about 100,000 people suffering from type 1 of the illness nationwide.

Professor Nikolai Petrovsky, director of endocrinology at Flinders Medical Centre, says this shows the role of a healthy diet as part of living with the disease.

“It demonstrates the importance of gut bacteria, both good and bad, in determining the outcome of diseases, including diabetes,” he said.

“So it really shows we are what we eat I guess.”

The research will be published in this week’s Nature journal.

They found that the “friendly” bugs appeared to stop the onset of the disease that affects hundreds of thousands of people in the UK in tests on mice.

Eventually they hope to make a pill, food supplement or even pro-biotic yoghurt that could reproduce the bacteria and so prevent the condition in those deemed high risk.

The study relates to type 1 diabetes that often develops in childhood when for some reason the body’s own immune system destroys insulin-producing cells in the pancreas. The condition has to be controlled by daily insulin injections and specialist diets.

Scientists at the University of Chicago and Yale, who published their findings in Nature, studied mice, with a pre-disposition for diabetes, that had had all bacteria removed from their bodies.

Raised in a completely germ-free environment, 80 per cent of the mice developed severe type 1 diabetes.

When they were given back a cocktail of the bacterial “flora” normally found in the mammalian gut, only around a third of the animals became ill.

The study showed that harmless bacteria could prevent type 1 diabetes even when there is a predisposition to the disease.

The scientists led by Dr Alexander Chervonsky, from the University of Chicago, and Li Wen at Yale University said the early findings could have implications for treating human patients.

Dr Cheryonsky said: “It is absolutely exciting. The onset of type 1 diabetes in genetic and very complex but we think it can be manipulated with these bacteria.

“Our ultimate goal is to identify the type (or types) of friendly bacteria and find a substance that they make to help to stop type 1 diabetes development.

“That could be made into a pill or supplement that we hope would be able to prevent the disease in high-risk people.”

Dr Wen at Yale University added: “Understanding how gut bacteria work on the immune system to influence whether diabetes and other autoimmune diseases occurs is very important.

“This understanding may allow us to design ways to target the immune system through altering the balance of friendly gut bacteria and protect against diabetes.”

The study also gave further weight to the “hygiene hypothesis” - the theory that a lack of exposure to parasites, bacteria and viruses in the developed world may be leading to increased risk of diseases like allergies, asthma, and other disorders of the immune system.

In the past decade, it has become evident that the environment plays a role in the development of some overly robust immune system responses. For instance, people in less-developed parts of the world have a low rate of allergy, but when they move to developed countries the rate increases dramatically.

The study did not relate to type 2 diabetes, the much more common form of the disease linked to obesity and lifestyle, affects almost two million Britons.

According to researchers, who will present their findings on Sept. 18 at the annual meeting of the American Association of Cardiovascular and Pulmonary Rehabilitation, in Indianapolis, high liver fat levels are common among people with type 2 diabetes and contribute to heart disease risk.

The study’s lead investigator, exercise physiologist Kerry Stewart, Ed.D., says the rise in the number of people with nonalcoholic fatty liver, mostly due to obesity, signals “a dark trend” because the disease, also called hepatic steatosis, may lead to cirrhosis and subsequent liver failure and transplantation, even cancer, as well as increased risk of diabetes-related heart disease.

“People with type 2 diabetes have added reason to be active and to exercise, not just because it is good for their overall health, but also because our study results pinpoint a key benefit to trimming the fatty liver that complicates their illness and which could accelerate heart disease and liver failure,” says Stewart, a professor of medicine and director of clinical and research exercise physiology at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute.

A majority of the quarter-million people who die each year from all kinds of diabetes do so as a result of some form of heart disease or stroke. And excess body fat is known to increase the likelihood of potentially life-threatening illness because the fat leads to more inflammation in the artery walls, high blood pressure and elevated blood cholesterol levels.

Stewart says the team’s study is believed to be the first to specifically demonstrate the beneficial role played by exercise in controlling hepatic fat levels in people with diabetes.

In the study, 77 diabetic men and women in Baltimore, Md., were divided into two groups.

For a six-month period, half of the study participants were put through a moderate program of sustained aerobic exercise consisting of 45-minute sessions three times a week. They could bicycle, run on a treadmill or take brisk walks. In addition, they lifted stacked weights for about 20 minutes, also three times a week, and not at a heavy-duty pace. The other half of the participants were asked to avoid any formal aerobic fitness or gym classes.

Special magnetic resonance imaging scans performed at the start and end of the study showed much lower levels of liver fat in the active group, while levels remained the same in the nonexercising group (at 5.6 percent and 8.5 percent, respectively). Physical fitness exams were also done.

Among the team’s other findings were better measures in general fitness and fatness among exercisers when compared to the nonexercising group. Averages for peak oxygen uptake levels during treadmill testing, or V02 levels, were greater by 13 percent (25.1 milliliters per kilogram per minute, compared to 22.2 milliliters per kilogram per minute), muscles were stronger by 7 percent (lifting 216.7 pounds, as opposed to 202.8 pounds for seven exercises tested), while percentages of body fat and body weight were each lower by 6 percent (35.5 percent versus 33.2 percent, and 98.5 pounds versus 92.2 pounds, respectively). Even waistlines shrunk on average by 2 inches (39 inches, compared to 41 inches).

“The benefits in improved fitness and fatness are clear, and physicians should really have all people with type 2 diabetes actively engaged in an exercise program,” says Stewart, who plans to further promote moderate exercise through direct talks with referring physicians and through his monthly health blog to the public while he amasses more evidence about the benefits of exercise in people with the disease. An estimated 14 million Americans have been diagnosed with this most common form of diabetes, in which the body cannot use its own life-sustaining insulin and eventually stops producing it.

Stewart says his team’s next steps are to analyze the long-term effect of moderate exercise on diabetes and heart disease, including any improvements in heart and blood vessel structure and function, insulin resistance and arterial inflammation.

Funding for the study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH), with additional assistance from the Johns Hopkins Bayview Institute for Clinical Translational Research, also funded by the NIH. Besides Stewart, other Johns Hopkins researchers who took part in this study were Susanne Bonekamp, D.V.M., Ph.D.; Bethany Barone, S.C.M.; Anita Bacher, M.S.N., M.P.H.; Kristina Potrekus, M.A.; John Moxley, M.A.; Nae-Yuh Wang, M.D.; and Jeanne Clark, M.D.

A new study shows some Pacific groups have higher rates of a potentially deadly lifestyle disease than others.

The New Zealand Medical Journal research says its comparisons suggest Tongan women and Samoan men suffer higher rates of type 2 diabetes and heart disease than other Pacific groups.

Thanks to Counties Manukau DHB’s Lotu Moui programme, the most at risks groups know they have to move it, or risk losing it.

One third of south Auckland’s 90,000 strong Pacific community are now hooked into the church-based Lotu Moui programme which involves fitness, health checks, diet advice and weight loss.

Tongan women surveyed had the highest rates of type 2 diabetes at over 35%, double the rate of their menfolk.

Samoan men were next highest at 26%. Niuean men and women had the lowest at 10% and 15% respectively.

Experts say part of the problem is westernisation.

“The data out of places like Samoa and so forth are that the rates are high there. Their lifestyles have assimilated much of the European lifestyle, perhaps in its worst manifestations”, says Middlemore Hospital Diabetologist Dr Brandon Orr-Walker.

No-one can say for sure why some Pacific groups have higher rates of diabetes than others, but all experts in south Auckland agree what is most important, is to continue to fight against the disease by diagnosing it early.