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

May 6, 2013 By MedNews Leave a Comment

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…]

Filed Under: Diabetes Tagged With: Diabetes, Ellen Leschek, Griffin P. Rodgers, NIH, TrialNet, Type 1 Diabetes TrialNet

Juvisync Approved for Combined Treatment of Diabetes and High Cholesterol

October 7, 2011 By MedNews Leave a Comment

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

Filed Under: Cholesterol, Diabetes Tagged With: (DPP-4, Diabetes, dipeptidyl peptidase 4, High Cholesterol, HMG-CoA reductase inhibitor, Juvisync, Mary H. Parks, MSD International GmbH Clonmel, simvastatin, sitagliptin, statin

Medical Costs for Youth With Diabetes 6x Higher

April 27, 2011 By MedNews 1 Comment

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

Filed Under: Diabetes Tagged With: Ann Albright, Centers for Disease Control (CDC), Cost of Diabetes, Diabetes, Diabetes Care, MarketScan Commercial Claims and Encounters Database

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

January 31, 2011 By MedNews Leave a Comment

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…]

Filed Under: Diabetes Tagged With: Diabetes, diabetes statistics, heart disease, stroke

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

January 26, 2011 By MedNews Leave a Comment

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…]

Filed Under: Diabetes Tagged With: Diabetes, prediabetes

Leading Causes of Death

December 9, 2010 By MedNews Leave a Comment

While deaths from stroke and several other chronic diseases are down, deaths due to chronic lower respiratory disease increased in 2008.

Stroke is now the fourth leading cause of death in the United States, down from the third place ranking it has held for decades, according to preliminary 2008 death statistics released today by CDC’s National Center for Health Statistics.

There were 133,750 deaths from stroke in 2008. Age-adjusted death rates from stroke declined 3.8 percent between 2007 and 2008. Meantime, there were 141,075 deaths from chronic lower respiratory disease and the death rate increased by 7.8 percent. [Read more…]

Filed Under: Cancer, Diabetes, Stroke

Genetics Influence Risk of Type 2 Diabetes

November 3, 2010 By MedNews Leave a Comment

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…]

Filed Under: Diabetes Tagged With: Diabetes, genetics, research

Undiagnosed Diabetes Patients May Also Have Undiagnosed Kidney Disease

March 27, 2010 By MedNews Leave a Comment

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)

Filed Under: Diabetes, General Health Tagged With: Diabetes, kidney

Onglyza, a New Type 2 Diabetes Drug Approved by FDA

August 1, 2009 By MedNews Leave a Comment

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

Filed Under: Diabetes, Drug Approvals, FDA News & Alerts Tagged With: Diabetes, fda, onglyza

Higher Levels of adiponectin Protein Associated with Lower Risk of Type 2 Diabetes

July 8, 2009 By MedNews Leave a Comment

Persons with higher levels of adiponectin, a protein that is produced by fat cells and that has anti-inflammatory and insulin-sensitizing properties, have an associated lower risk of type 2 diabetes, according to an analysis of previous studies, reported in the July 8 issue of JAMA.

Some studies have suggested several mechanisms through which adiponectin may decrease the risk of type 2 diabetes, although the strength and consistency of the relation between plasma adiponectin and risk of type 2 diabetes has been unclear, according to background information in the article.

Shanshan Li, M.D., M.Sc., of the Harvard School of Public Health, Boston, and colleagues conducted a review and meta-analysis to assess the consistency of the association of adiponectin levels and risk of type 2 diabetes. The researchers identified thirteen studies with a total of 14,598 participants and 2,623 new cases of type 2 diabetes that met criteria for inclusion in the meta-analysis.

The authors found that higher adiponectin levels were associated with a lower risk of type 2 diabetes. This inverse association was consistently observed in whites, East Asians, Asian Indians, African Americans and Native Americans. The results did not differ substantially by method of diabetes ascertainment, study size, follow-up duration, body mass index or proportions of men and women.

“Although these epidemiologic studies cannot establish causality, the consistency of the association across diverse populations, the dose-response relationship, and the supportive findings in mechanistic studies indicate that adiponectin is a promising target for the reduction of risk of type 2 diabetes,” the authors write.

The researchers add that recent studies have shown that adiponectin levels can be increased through pharmaceutical and lifestyle interventions. “In addition, adiponectin levels may be useful for identifying persons likely to benefit most from interventions to treat ‘dysfunctional adipose tissue’ and its metabolic complications. Future studies should also evaluate whether adiponectin is useful for prediction of type 2 diabetes in addition to established risk factors using statistical techniques appropriate for prognostic analyses.”

Source: JAMA. 2009;302[2]:179-188

Filed Under: Diabetes

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