FDA approves new treatment for Type 2 diabetes

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.

People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

"This approval provides another treatment option for the millions of Americans 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. “It is effective when used alone or when added to existing treatment regimens.”

Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.

Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.

Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.

Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

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FDA significantly restricts access to the diabetes drug Avandia

The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Also today, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings.

In addition, the agency halted the GSK’s clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs.

The FDA may take additional actions after the independent re-analysis of RECORD is completed.

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Study on Fructose and Pancreatic Cancer Generates Premature and Potentially Misleading Conclusions

/PRNewswire/ -- A study published in the August issue of Cancer Research (1) has resulted in several premature and potentially misleading conclusions when it comes to fructose and its effect on pancreatic tumor cells. Unfortunately, the media covering this story, and even the authors, have been too quick to extrapolate the results of laboratory research on pure fructose to real-world conditions, which is not appropriate or helpful to consumers.

The main contribution of this paper is to demonstrate that cancer cells utilize fructose as an alternate substrate to glucose for fueling growth. Cancer cells are well known for having multiple mechanisms to escape the body's normal controls, which makes controlled laboratory studies poor models for generating meaningful results.

This study does not look at the way fructose is actually consumed by humans, as it was conducted in a laboratory, not inside the human body. The study also narrowly compared pure fructose to pure glucose, neither of which is consumed in isolation in the human diet. Humans consume a wide array of foods that contain both fructose and glucose in combination along with many other sugars and nutrients. Most notably, both sugar (sucrose) and high fructose corn syrup contain roughly 50 percent glucose and 50 percent fructose.

The study's authors inaccurately state that high fructose corn syrup is the most significant source of fructose in the diet, whereas in the United States more fructose is still consumed from sugar than from high fructose corn syrup. Indeed, worldwide, humans consume nine times as much sucrose as they do high fructose corn syrup. Fructose is a natural, simple sugar also commonly found in fruits, vegetables, table sugar, maple syrup, and honey.

The causes of pancreatic cancer are poorly understood. To blame one component of the diet is highly speculative based on one, small study done in a Petri dish.

People should seek the advice of physicians, rather than rely on any one study, to make important decisions on medical treatment for a serious disease such as cancer.

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Glucose Challenge 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.