Online Sign Up and Nationwide Testing Program Launched for Type 1 Diabetes Network

Type 1 Diabetes NetworkPeople with a family history of type 1 diabetes can now conveniently participate in free screening to help find ways to delay or prevent the disease, even if they live far from a study site. This alternative to site-based initial screening comes as modern technology enables more secure online registration for medical research.

After volunteers consent online to participate in Type 1 Diabetes TrialNet — a study aimed at discovering ways to delay or prevent type 1 diabetes – they receive a screening kit in the mail, as shown, and will be directed to a local lab for a blood test at no cost to the volunteer. Courtesy of University of South Florida. [Read more…]

Juvisync Approved for Combined Treatment of Diabetes and High Cholesterol

First combination drug to treat type 2 diabetes and high cholesterol in one tablet.

The U.S. Food and Drug Administration (FDA) today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood.

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.

The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

Juvisync is approved with a Medication Guide that provides important information to patients. The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea.

Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

Source: FDA

Medical Costs for Youth With Diabetes 6x Higher

Young people with diabetes face substantially higher medical costs than children and teens without the disease, according to a recent article in the May issue of the journal Diabetes Care. The study found annual medical expenses for youth with diabetes are $9,061, compared to $1,468 for youth without the disease.

Much of the extra medical costs come from prescription drugs and outpatient care. Young people with the highest medical costs were treated with insulin, and included all those with type 1 diabetes and some with type 2 diabetes. People with type 1 diabetes cannot make insulin anymore and must receive insulin treatment. Some people with type 2 diabetes also are treated with insulin, because their bodies do not produce enough to control blood glucose (sugar).

Children and adolescents who received insulin treatment had annual medical costs of $9,333, compared to $5,683 for those who did not receive insulin, but did take oral medications to control blood glucose.

“Young people with diabetes face medical costs that are six times higher than their peers without diabetes,” said Ann Albright, Ph.D., R.D., director of CDC’s Division of Diabetes Translation. “Most youth with diabetes need insulin to survive and the medical costs for young people on insulin were almost 65 percent higher than for those who did not require insulin to treat their diabetes.”

The study examined medical costs for children and teens aged 19 years or younger who were covered by employer-sponsored private health insurance plans in 2007, using the MarketScan Commercial Claims and Encounters Database. The estimates were based on administrative claim data from nearly 50,000 youth, including 8,226 with diabetes.

Medical costs for people with diabetes, the vast majority of whom are adults, are 2.3 times higher than costs for those without diabetes, according to CDC’s National Diabetes Fact Sheet, 2011. Authors of the Diabetes Care study suggest that the difference in medical costs associated with diabetes may be greater for youth than for adults because of higher medication expenses, visits to specialists and medical supplies such as insulin syringes and glucose testing strips.

Among youth with diabetes, 92 percent were on insulin, compared to 26 percent of adults with diabetes. Insulin is a hormone produced by the pancreas that helps convert blood glucose into energy. Without adequate insulin, blood glucose levels rise and can eventually lead to serious health complications, including heart disease, kidney failure, blindness, nerve damage and amputation of feet and legs.

Type 1 diabetes develops when the body’s immune system destroys insulin-producing beta cells in the pancreas. Risk factors may be genetic or environmental. There is no known way to prevent type 1 diabetes.

In type 2 diabetes, the body no longer handles insulin properly and gradually loses the ability to produce it. Risk factors include obesity, older age, family history, physical inactivity, history of diabetes while pregnant, and race/ethnicity. Type 2 diabetes is extremely rare in children younger than 10 years. Although type 2 diabetes is infrequent in children and teens aged 10 to 19 years, rates are higher in this group compared to younger children, with higher rates among minorities.

Source: CDC; Diabetes Care, May 2011

35% of U.S. Adults Over 20 Have Pre-Diabetes

Nearly 26 million Americans have diabetes, according to new estimates from the Centers for Disease Control and Prevention (CDC). In addition, an estimated 79 million U.S. adults have prediabetes, a condition in which blood sugar levels are higher than normal, but not high enough to be diagnosed as diabetes. Prediabetes raises a person’s risk of type 2 diabetes, heart disease and stroke.

Diabetes affects 8.3 percent of Americans of all ages, and 11.3 percent of adults aged 20 and older, according to the National Diabetes Fact Sheet for 2011. About 27 percent of those with diabetes—7 million Americans—do not know they have the disease. Prediabetes affects 35 percent of adults aged 20 and older. [Read more…]

26 Million American Have Diabetes; 79 Million Have Pre-Diabetes

Nearly 26 million Americans have diabetes, according to new estimates. In addition, an estimated 79 million U.S. adults have prediabetes, a condition in which blood sugar levels are higher than normal, but not high enough to be diagnosed as diabetes. Prediabetes raises a person’s risk of type 2 diabetes, heart disease and stroke.

Diabetes affects 8.3 percent of Americans of all ages, and 11.3 percent of adults aged 20 and older, according to the National Diabetes Fact Sheet for 2011. About 27 percent of those with diabetes—7 million Americans—do not know they have the disease. Prediabetes affects 35 percent of adults aged 20 and older. [Read more…]

Genetics Influence Risk of Type 2 Diabetes

A team led by researchers at the National Human Genome Research Institute (NHGRI),  has captured the most comprehensive snapshot to date of DNA regions that regulate genes in human pancreatic islet cells, a subset of which produces insulin.

The study highlights the importance of genome regulatory sequences in human health and disease, particularly type 2 diabetes, which affects more than 20 million people in the United States and 200 million people worldwide.

“This study applies the power of epigenomics to a common disease with both inherited and environmental causes,”said NHGRI Scientific Director Daniel Kastner, M.D., Ph.D. “Epigenomic studies are exciting new avenues for genomic analysis, providing the opportunity to peer deeper into genome function, and giving rise to new insights about our genome’s adaptability and potential.” [Read more…]

Undiagnosed Diabetes Patients May Also Have Undiagnosed Kidney Disease

Millions of Americans may have chronic kidney disease (CKD) and not know it, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN).

“Our research indicates that much of the CKD burden in the United States is in persons with prediabetes and undiagnosed diabetes, who are not being screened for CKD,” comments Laura C. Plantinga, ScM (University of California, San Francisco). The researchers believe that broader screening may be needed to detect patients with these two “relatively silent yet harmful diseases.”

In a study funded by the Centers for Disease Control and Prevention, Plantinga and colleagues analyzed a nationally representative sample of about 8,200 Americans from the National Health and Nutrition Examination Survey. Standard laboratory tests were used to assess the rate of CKD, focusing on people with undiagnosed diabetes or prediabetes (sometimes called “borderline” diabetes).

Based on lab tests, 42 percent of subjects with undiagnosed diabetes had CKD—similar to the 40 percent rate in those with diagnosed diabetes. “Only a small percentage of participants were aware of the diagnosis of CKD,” says Plantinga.

In addition, CKD was present in nearly 18 percent of subjects with prediabetes. Among participants without diabetes or prediabetes, the rate of CKD was about 11 percent.

“Based on these results, there may be a substantial number of individuals in the United States—up to 13 million—who have undiagnosed diabetes or prediabetes and who already have signs of kidney damage and/or reduced kidney function,” says Plantinga. Such patients would be at high risk for worsening kidney disease and diabetes, and for the poor outcomes associated with both conditions—including cardiovascular disease and death.

Diabetes is the most important risk factor for kidney disease, but the new results suggest that harmful effects on the kidneys may be occurring even before diabetes is diagnosed. “Persons at risk for diabetes and their health care providers should be aware that earlier screening for both diabetes and kidney disease may be warranted,” says Plantinga. “Earlier screening would allow for appropriate, timely medical care to prevent further progression and poor outcomes.”

In an accompanying editorial, Gary C. Curhan, MD, ScD (Brigham and Women’s Hospital, Boston, MA) calls for CKD screening to be extended to patients with prediabetes. Curhan also suggests that it may be time to consider the concept of “pre-CKD”—identifying patients at a very early stage of CKD when the disease may still be preventable or reversible.

Although the study shows an association, it cannot determine whether the development of CKD followed the development of diabetes, or whether CKD was actually caused by diabetes. There is also likely some misclassification of both diseases, although the association remained significant when tested under a range of different assumptions.

Study co-authors include Deidra C. Crews, Josef Coresh, Edgar R. Miller III (Johns Hopkins University, Baltimore, MD), Rajiv Saran, Elizabeth Hedgeman (University of Michigan, Ann Arbor), Jerry Yee (Henry Ford Hospital, Detroit, MI), Meda Pavkov, Mark S. Eberhardt, Desmond E. Williams (Centers for Disease Control and Prevention, Atlanta, GA), and Neil R. Powe (University of California, San Francisco) on behalf of the Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team.

Disclosures: The authors reported no financial disclosures.

Source: Clinical Journal of the American Society Nephrology (CJASN), “Prevalence of Chronic Kidney Disease in US Adults with Undiagnosed Diabetes or Prediabetes,” (doi 10.2215/CJN.07891109) and the accompanying editorial,” Pre-Diabetes, Pre-Hypertension…is it time for Pre-CKD?” (doi 10.2215/CJN.01650210)

Avosentan Reduces Urinary Protein Loss but May Cause Serious Side Effects, Says Study

The drug avosentan substantially reduces urinary protein loss in people with type 2 diabetes and kidney disease, but the drug causes serious side effects, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). The results suggest that lower doses of avosentan may have a more favorable risk/benefit ratio for patients.

Despite aggressive treatments, individuals with kidney disease often experience proteinuria, or excessive loss of protein in the urine, which increases kidney damage. A key factor in the development of proteinuria is endothelin, which by constricting blood vessels and raising blood pressure, causes the kidney’s filtering function to deteriorate. Researchers suspect that blocking the endothelin peptide could be a promising new treatment strategy for patients who develop proteinuria. Endothelin antagonists such as oral avosentan are already available and are prescribed for patients with cardiovascular conditions.

Johannes Mann, MD (Schwabing General Hospital and KfH Kidney Centre, in Munchen, Germany) and his colleagues examined the effects of avosentan on proteinuria and kidney function in patients with type 2 diabetes and kidney disease through a multicenter, multinational, double-blind, controlled trial. The Avosentan ASCEND study enrolled 1392 patients already being treated for kidney disease and randomized them to receive avosentan 25 mg, avosentan 50 mg, or placebo.

While avosentan at either dose lowered patients’ urinary protein excretion by 40%-50% (compared with less than 10% in patients taking placebo), individuals taking the drug experienced a high incidence of serious, sometimes life-threatening side effects. These included complications of fluid overload such as pulmonary edema, as well as congestive heart failure. In addition, there were more deaths in the groups taking avosentan (21 and 17) than in the group taking placebo (12).

Dr. Mann noted that the findings from the ASCEND trial highlight the risks and potential benefits of endothelin antagonists in kidney disease patients with proteinuria and will help investigators design future studies to test the drugs’ potential. Specifically, lower doses of avosentan may generate more positive results.

Speedel Pharma Ltd, Switzerland, sponsored the study and appointed the contract research organization Quintiles Ltd for study set-up, initiation, management, and analysis. (Disclosures: Susan Kuranoff and Thomas Littke were employees of the sponsor, and all other authors have consulting funds from Speedel Pharma Ltd.

Source: Journal of the American Society Nephrology, “Avosentan for Overt Diabetic Nephropathy,” online ed. (February 18, 2010, doi 10.1681/ASN.2009060593); American Society of Nephrology (ASN).

Onglyza, a New Type 2 Diabetes Drug Approved by FDA

The U.S. Food and Drug Administration (FDA) today 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.

Source: FDA, July 31, 2009

Controversial Recommendation to Consider Statins for Kids with High Cholesterol

The American Academy of Pediatrics has issued new cholesterol screening and treatment recommendations for children that suggest cholesterol screening, and possible use of statins for certain children.

The policy statement, “Lipid Screening and Cardiovascular Health in Childhood,” recommends cholesterol screening of children and adolescents with a family history of high cholesterol or heart disease. It also recommends screening patients whose family history is unknown or those who have other factors for heart disease including obesity, high blood pressure or diabetes.

The AAP suggests that screening should take place after age two, but no later than age 10. The best method for testing, according to the organization’s policy statement, is a fasting lipid profile. If a child has values within the normal range, testing should be repeated in three to five years.

The American Academy of Pedatrics suggests that for children who are more than eight years old and who have high LDL concentrations, cholesterol-reducing medications should be considered. Younger patients with elevated cholesterol readings should focus on weight reduction and increased activity while receiving nutritional counseling.

The policy statement also recommends the use of reduced-fat dairy products, such as two percent milk, for children as young as one year of age for whom overweight or obesity is a concern.

Source: American Academy of Pediatrics, July 7, 2008