FDA Approves New Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.

Insulin is a hormone that helps prevent sugar (glucose) from building up in the blood. People with type 2 diabetes have difficulty making and using insulin. Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists that help the pancreas make more insulin after eating a meal.

"Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. "Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with type 2 diabetes a treatment option for controlling their blood glucose levels."

In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis.

The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.

Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product.

In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years.

In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive.

It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2.

To ensure the safe and effective use of this product, Victoza was approved with a Risk Evaluation and Mitigation Strategy consisting of a Medication Guide and a Communication Plan to help patients and providers understand the risks of Victoza and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer.

Victoza is manufactured by Novo Nordisk of Bagsvaerd, Denmark.

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FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today (July 31) approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

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Test is Accurate and Economical for Diabetes and Prediabetes Screening

A test commonly used to help identify women with diabetes during pregnancy may be an accurate, convenient and inexpensive way to screen the general population for unrecognized diabetes and prediabetes, according to Emory University researchers.

The results of the study, "Glucose challenge test screening for prediabetes and undiagnosed diabetes" will be published online and in print in the journal Diabetologia.

"Widespread use of the glucose challenge test (GCT) to screen Americans for prediabetes and diabetes could provide a major opportunity to improve the health of more than 40 million people," said lead study author Lawrence S. Phillips, MD, Emory University School of Medicine Professor of Medicine, Division of Endocrinology.

The study screened 1,573 volunteer participants who had never been diagnosed with diabetes. At a first visit, at different times of the day and without restriction of meals, participants were given a 50-gram glucose drink. Glucose was measured both before the drink (random glucose) and an hour after the drink (GCT glucose).

At a follow-up visit held in the morning after an overnight fast, participants had measurement of hemoglobin A1c (a standard test used to monitor diabetes), and a 75-gram oral glucose tolerance test (OGTT). The OGTT is the "gold standard" for diagnosing diabetes and prediabetes.

After screening, researchers found that 4.6 percent of the participants had previously unrecognized diabetes, and 18.7 percent had prediabetes.

The GCT was the most accurate screening test for these problems, significantly better than the random glucose or A1c tests. Since the good performance of the GCT was unaffected by the time of day, or times after meals, the GCT could be performed during a routine office visit. If a patient's GCT glucose level is low, he/she wouldn't need to be screened again for another two or three years, but if the GCT glucose level is high, patients would need a confirmatory oral glucose tolerance test.

This approach is similar to screening women for diabetes during pregnancy. GCT screening is almost universal for women in their sixth month of pregnancy.

The GCT provided consistent results for a diverse group of patients - old and young, normal weight and overweight, men and women, with and without a family history of diabetes, etc. The GCT also appeared to be less expensive than other screening strategies.

Early diagnosis is a benefit both for people who have diabetes or prediabetes, and for their health care teams. Regular glucose challenge test screening (GCT first, then a follow-up OGTT if the GCT glucose is high) would be a way to assure early diagnosis, according to Phillips and team.

"Glucose challenge test screening could help improve disease management by permitting early initiation of therapy aimed at preventing or delaying the development of diabetes and its complications," says Phillips.

Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life.

According to the American Diabetes Association, 23.6 million U.S. children and adults, or 7.8 percent of the population, have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, 5.7 million people are unaware that they have the disease.

Pre-diabetes is a condition that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. There are 57 million Americans who have pre-diabetes, in addition to the 23.6 million with diabetes.

In addition to Phillips, study authors were: David Koch, PhD, K.M. Venkat Narayan, MD, MSc, MBA, Mary Rhee, MD, Viola Vaccarino, MD, PhD, and David Ziemer, MD, of Emory University; Ranee Chatterjee, MD, of the Johns Hopkins University School of Medicine; and P. Kolm and W.S. Weintraub, of the Christiana Care Health System in Newark, Del.

The research was supported in part by the National Institutes of Health and the National Center for Research Resources, and by the Veterans' Administration. The work was presented in part at the June 2008 national meeting of the American Diabetes Association.

From Woodruff Health Sciences Center

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Overweight Siblings of Children With Type 2 Diabetes Likely to Have Abnormal Blood Sugar Levels

/PRNewswire-USNewswire/ -- Overweight siblings of children with type 2 diabetes are four times more likely to have abnormal glucose levels compared to other overweight children. Because abnormal glucose levels may indicate risk for diabetes or diabetes itself, these children could benefit from screening tests and diabetes prevention education.

Researchers from The Children's Hospital of Philadelphia published their findings today in the online edition of the Journal of Pediatrics.

"To our knowledge, previous studies have not specifically looked at the risk of abnormal glucose tolerance among siblings of children diagnosed with type 2 diabetes. This group has a unique combination of genetic and environmental risk factors," said Sheela N. Magge, M.D., M.S.C.E., pediatric endocrinologist at The Children's Hospital of Philadelphia and primary author of the study. "Clinical experience suggests that children with type 2 diabetes often have an obese sibling, which makes siblings an appropriate target for prevention trials."

The study looked at 62 children: 20 obese subjects with a sibling who had type 2 diabetes and a control group of 42 obese children. The groups were similar for age, gender, racial distribution (predominantly African American), pubertal status and body mass index over 95th percentile.

The researchers found that overweight siblings of children with type 2 diabetes had four times greater odds of having abnormal glucose levels (impaired glucose tolerance or type 2 diabetes) than other overweight children. However, investigators found no significant differences in insulin resistance, as measured by the homeostasis model assessment.

Type 2 diabetes is caused by a combination of both genetic and environmental factors. Known risks include obesity, decreased physical activity, race/ethnicity, family history and insulin resistance. Obesity decreases insulin sensitivity, as does puberty, when all adolescents experience a period of relative insulin resistance. In obese adolescents already at risk of developing type 2 diabetes, the increase in insulin resistance during puberty may be enough to unmask disease. Family history is also important; 74-100 percent of children with type 2 diabetes have a first- or second-degree relative who also has the condition.

Not all children with a family history of type 2 diabetes, insulin resistance or obesity develop type 2 diabetes, cautions Dr. Magge.

The researchers also add that identifying groups at high-risk for type 2 diabetes during childhood, such as obese siblings of children with type 2 diabetes, could help guide screening of obese children for abnormal glucose tolerance by primary care providers. This could also help to identify children who might benefit from participation in future type 2 diabetes prevention studies.

Dr. Magge's coauthors were: Nicolas Stettler, M.D., M.S.C.E., Abbas Jawad, M.Sc., Ph.D., and Lorraine E. Levitt Katz, M.D. all of The Children's Hospital of Philadelphia and the University of Pennsylvania.

The research was supported by grants from the National Institutes of Health and the National Center for Research Resources.

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New Uses for Old-Line Diabetes Monitoring Test: Screening and Diagnosis

A blood test currently used as the gold standard for monitoring people already under care for diabetes may have far wider use in identifying millions with undetected diabetes, a team led by a Johns Hopkins physician suggests.

The hemoglobin A1c test (HbA1c), based on a blood sample, is widely used to keep tabs on how well confirmed diabetics keep their blood sugar, or glucose, in check by showing how much glucose red blood cells have been exposed to for the past 120 days, the average lifespan of these cells.

"The test is a measure of long-term glucose control, but doctors don't typically use it to screen for or diagnose the disease, " says Christopher Saudek, M.D., professor of endocrinology and metabolism at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Comprehensive Diabetes Center. "There's reason to believe it could help identify many of the estimated six million people in the U.S. who have diabetes but don't know it," he adds. The current screening and diagnostic tests measure only the amount of sugar present at the moment that blood sample is taken. Consequently, Saudek says, these tests are accurate only if patients fast for at least 10 hours before the test because glucose concentrations can vary greatly depending on a person's recent meals.

Even then, explains Saudek, the tests miss a significant portion of people who have diabetes or are at high risk to develop the disease since glucose also varies depending on a person's diet and exercise regimen for several days leading up to the blood draw.

"If a patient is scheduled for a physical, he or she may 'tune up' by changing their regimen for a few days and throw off their test results, causing doctors to miss the patient's usual pattern of high blood sugar," he says.

In a consensus statement published in the July Journal of Clinical Endocrinology and Metabolism, Saudek and his colleagues conclude that the HbA1c test should be used as a front-line method for identifying patients with diabetes, especially for those at high risk for the disease. Since the test does not require fasting and isn't affected by short-term changes in diet and exercise, the HbA1c test has significant advantages to current testing methods.

The consensus was reached by a group of diabetologists, pathologists and internists seeking to improve detection methods because of the serious consequences of untreated diabetes for patients and public health. They met recently in Chicago with financial support from Metrika Inc., a major manufacturer of diabetes testing equipment. The panel deliberations and manuscript preparation were made independently of the sponsor, according to its members.

After reviewing relevant published studies and available tests, the national panel recommended that individuals who score at least 6 percent on an HbA1c test may have or be at risk for diabetes and should be tracked with additional glucose or HbA1c tests. Those who score between 6.5 percent or above, if confirmed, should be considered to have diabetes.

"This is a first step towards changing medical practice," notes Saudek, and "could greatly enhance how well we're able to identify people with diabetes."

Others who contributed to the consensus statement include William H. Herman of the University of Michigan School of Medicine, David B. Sacks of Brigham & Women's Hospital and Harvard Medical School, Richard M. Bergenstal of the International Diabetes Center, David Edelman of Durham Veterans Administration Medical Center and Duke University, and Mayer B. Davidson of Charles R. Drew University.

Diabetes Experts Recommend One-Two Punch for Treating Patients with Pre-Diabetes

BUSINESS WIRE --For the first time, a consensus of diabetes and metabolic disorder experts have recommended a comprehensive treatment regimen for patients with pre-diabetes. The recommendations call for specific guidelines on both lifestyle, and pharmaceutical intervention where appropriate. The recommendations are made in a Consensus Statement released this morning by the American Association of Clinical Endocrinologists (AACE).

Pre-diabetes is a condition defined by elevated fasting glucose levels or impaired glucose tolerance. According to the Centers for Disease Control (CDC), more than 56 million Americans currently have the condition, which leaves patients at risk, not only for developing type 2 diabetes, but also for cardiovascular complications. This is an extension of the effort to recognize and treat type 2 diabetes earlier and more aggressively.

However, at this time, there are no pharmacologic therapies that have been approved by the FDA for prevention of the conversion of pre-diabetes to diabetes. That’s why the expert panel has recommended a two-pronged approach to treating pre-diabetes. The first is intensive lifestyle management to prevent the progression to type 2 diabetes.

“As individuals and as a society, we need to address those forces which are creating the epidemic of obesity, diabetes, and pre-diabetes,” said Yehuda Handlesman, MD, FACP, FACE, Treasurer of AACE and Medical Director of the Metabolic Institute of America. “We understand the difficulties in implementing solutions, but as an association of endocrinologists we are committed to supporting community and national efforts in every way we can.”

The recommendation calls for patients to adhere to the guidelines set forth in the Diabetes Prevention Program, established by the United States government.

“Although lifestyle can clearly modify the progression of patients towards overt diabetes, it may not be sufficient,” said Alan J. Garber, MD, PhD, FACE, Professor of Medicine, Baylor College of Medicine, Houston, and Chairman of the Consensus Conference. “Medications may well be required, particularly in high risk groups.”

The second approach is to prevent the development of cardiovascular complications, and to help those patients where lifestyle modifications have been insufficient to modify cardiovascular risk factors. This requires cardiovascular risk reduction medications for abnormal blood pressure and cholesterol independent of glucose control medications.

“The data show that there is a spectrum of severity, with the most severely affected approaching the risks of people with diagnosed type 2 diabetes,” said Daniel Einhorn, MD, FACP, FACE, Vice President of AACE and Medical Director of the Scripps Whittier Institute for Diabetes in La Jolla, CA. “In these highest risk individuals, who represent a minority, pharmacologic strategies may be appropriate if intensive lifestyle therapies fail. Regardless, all individuals at risk for diabetes should be aware of the level of their risk factors and be prepared to take action.”

While the number of people with pre-diabetes in the United States exceeds 56 million, most patients with the condition have not been diagnosed. People are considered high risk if they have near diabetic levels of blood glucose, hypertension, or abnormal lipid profiles. These patients should consider working with their doctor to monitor their status.

The preliminary publication of the Consensus Statement is available at media.aace.com. The final document will be published later this year in Endocrine Practice, the Journal of the American Association of Clinical Endocrinologists.