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Archive for the Diabetes News

Is Oral Insulin on the Way?

Posted at 25th February 2013 by Ryan Luce

written by Michael O’Leary

Two companies announced clinical trials in the last three weeks aimed at bringing insulin taken by mouth to market.

Generex Biotechnology Corporation announced at the end of January results of a phase III clinical trial showing that its oral insulin spray Oral-lyn™ is as effective as subcutaneously injected regular insulin. The 12-week study conducted by an Indian licensee of Generex involved 209 men and women with type 2 diabetes at 14 clinics in India who did not have well controlled blood sugar levels with oral diabetic drugs.

While the Indian company that conducted the trial released few details of the study results, it advised the drug’s maker, Generex, that it had submitted the study results to Indian drug approval agencies and expected it to be approved this summer. The drug comes in an inhaler, much like asthma drugs, and is delivered in a metered spray through the mouth.

Last week Israeli company Oramed Pharmaceuticals reported that it is ready to launch a phase II clinical trial that it hopes will take it one step closer to putting its oral capsule on the market for people with type 2 diabetes.  The study will be conducted at 12 clinical sites in the U.S. and will enroll close to 150 people.

Scientists have been searching for a way to administer oral insulin for more than 100 years. The difficulty is that stomach acid breaks down the insulin making it unusable by the body, and the intestines block absorption of large molecules such as insulin. Inhaled insulin has been tried, but early versions met with an increased risk of lung cancer.

Generex and Oramed have overcome these limitations by changing the delivery route of the insulin.

Oramed’s capsule overcomes the dual obstacles of stomach acid and molecule size with a special capsule coating that protects the insulin through the esophagus and stomach, and into the intestines. There the capsule breaks down and releases the insulin along with an absorption enhancer that transports the insulin protein across the intestinal membrane. Once across the membrane, the insulin travels through the blood directly to the liver where it is used like natural insulin.

In Generex’s case while it is sprayed into the mouth, it is not inhaled. Instead it is absorbed into the blood stream through the mucous membrane in the mouth.

A number of other companies with a variety of delivery strategies are all racing to get oral insulin tested and approved. Until recently most experts doubted an oral insulin could be achieved. Now, as Oramed CEO Nadav Kidron, said in an interview with Israeli magazine 21c, it is no longer a question of if, but when.

“When they initiated this project almost 30 years ago at Hadassah (University in Israel), trying to get insulin delivered orally looked almost impossible,” says Kidron. “Today it’s just a matter of time till it’s on the market.”

 

What Are The Best Diabetes Diets?

Posted at 14th January 2013 by Ryan Luce

U.S. News makes their list

More Evidence for Surgery for Type 2 Diabetes?

Posted at 31st December 2012 by Ryan Luce

Intensive lifestyle changes including diet and exercise were significantly more effective than standard counseling and medications for reversing type 2 diabetes, an ongoing federal study shows. But the success rate may add fuel to the debate for those advocating surgery as a more effective method of reversing the disease.

Funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Look AHEAD: Action for Health in Diabetes study began in 2001 and continues today, but is no longer recruiting participants. The researchers led by Edward Gregg, acting director, Division of Heart Disease and Stroke Prevention,

National Center for Chronic Disease Prevention and Health Promotion, at the CDC aimed to determine whether lifestyle changes can reverse type 2 diabetes and whether the effects  are sustained over time.

The 4,503 participants were 45 to 75 years old with an average age of 59 years. They had a median of five years since being diagnosed with diabetes, meaning half had been diagnosed more than five years prior to starting the trial and half had been diagnosed less than five years before. All had body mass index (BMI) scores that placed them in the obese category. Partial remission of diabetes was defined as meeting the criteria for prediabetes and complete remission was defined as having a nondiabetic blood sugar levels or a fasting blood sugar level of less than 126 mg/dL and HbA1c of less than 6.5 percent without medication.

The interim results, reported in the Dec. 19 Journal of the American Medical Association, showed that 11.5 percent of the 2,241 people in the intensive lifestyle group achieved a partial reversal of their diabetes after one year, compared to 7.3 percent of 2,262 in the standard treatment group. Complete reversal of the disease occurred much less often, with only 1.3 percent of the intensive lifestyle group achieving a complete remission after one year and 0.7 percent after four years.

The differences between the two groups were sustained over four years, although the percentage of participants who achieved partial remission of type 2 diabetes declined each year with only 7.3 percent of the lifestyle group meeting the goal after four years.

In an editorial in the same issue Dr. David E. Arterburn of Group Health Research Institute, Seattle, and Dr. Patrick J. O’Connor of HealthPartners Institute for Education and Research in Minneapolis, pointed out that the partial reversal of the disease failed to translate into fewer heart attacks and strokes.

They noted that while other lifestyle trials have shown similarly disappointing results, the evidence is growing that weight-loss surgery may be more effective than either lifestyle treatments or medicines for reversing type 2 diabetes.

Is Victoza Better Than Bydureon?

Posted at 2nd December 2012 by Ryan Luce

written by Michael O’Leary

In a head-to-head comparison of the daily type 2 diabetes drug Victoza and weekly injections of Bydureon, those taking the daily drug did significantly better in lowering their HbA1c than those taking the weekly injections.

The down side was that those taking the higher than normal dose of Victoza had more side effects.

The results were published in the Nov. 7 Lancet and reported by MedPage Today. The study named DURATION-6 was designed to be what researchers call a non-inferiority trial. A way of lowering the bar to show that drug A is not less effective than drug B.

In this case they wanted to see if the once-weekly GPL-1 drug, Bydureon, was at least not any less effective than daily Victoza in lowering blood sugar. The trial involved 911 patients with type 2 diabetes at 105 study sites in 19 countries. While 450 were randomly assigned to the Victoza group and 461 were assigned to Bydureon, patients knew which drug they were taking.

After 26 weeks the average reduction in HbA1c  for the Victoza group was 1.48 percent and the reduction in the Bydureon group was 1.28 percent. This difference was greater than the study design’s defined criteria for determining that once-weekly Bydureon is at least as effective as daily Victoza.

The most common side effects were nausea, experienced by 21 percent of those in the Victoza group, diarrhea 13 percent, and vomiting 11 percent. By contrast, 6 percent of the Bydureon group experienced diarrhea, 4 percent vomiting. The side effects declined over the course of the study for both groups.

Drs. Tina Thethi and Vivian Fonseca of Tulane University pointed out several flaws in the study in an editorial that appeared with the study. The 1.8 mg dose of Victoza was higher than the usual dose of 1.2 mg, which might account for the higher rate of side effects, and increased lowering of blood sugar levels in the Victoza group than might normally be seen at the usual dose.

“A true comparison could have been made between the maximum tolerated doses of each drug,” they wrote.

They also noted that there might have been differences in the characteristics of the patients in each study group that were not evaluated in the study. One such characteristic they mentioned was the formation of antibodies, which they suggested may have resulted in the Bydureon group not responding as well as expected.

The study was funded by Eli Lilly and Amylin, which previously co-marketed Bydureon. Lilly is currently developing its own version of the drug. Novo Nordisk makes Victoza and recently received backing by an FDA panel for approval of its once-weekly drug Tresiba.

 

Good News For Potential Approval of Tresiba – A New Long-Acting Insulin

Posted at 25th November 2012 by Ryan Luce

written by Michael O’Leary

Last week an FDA advisory panel recommended degludec, a once-daily injectable insulin, be approved by the FDA, but will require Novo Nordisk to conduct additional trials to assess the heart risk that may be posed by the drug.

As reported by Fierce Biotech, Reuters and others the outside panel of non-FDA medical experts recommended approval by an 8-4 vote, but unanimously voted to require additional studies to assess the heart risk.

In recommending approval, the panel looked at the combined study results of 16 clinical trials Novo has conducted involving more than 9,000 people with type 1 diabetes and those with type 2 diabetes who are no longer able to control their blood sugar levels with other medications alone.

The panel was impressed by the effectiveness of the drug’s long-acting characteristics, which allow people to take it at a different time of the day should they miss their dose at their regular time, which is not the case with current drugs.

Panel member Dr. David Cook who is an associate professor of pediatrics at Johns Hopkins University School of Medicine told Reuters that current basal insulins don’t last 24-hours, and one that does give constant coverage for 24 hours would make a difference.

In one study designed to demonstrate the flexibility of degludec showed effectiveness comparable to Sanofi’s Lantus. As presented at the American Diabetes Association meeting in 2010 and reported by Diabetes In Control.com, dosing that allowed patients to go days without a shot using the flexible insulin degludec schedule wasn’t any less effective for glucose control than once-daily dosing. Both degludec and Lantus lowered A1c by 1.3 percent to an average of 7.2 percent.

The studies the panel evaluated were designed to test blood sugar control, but a small number of people experienced heart-related events, such as heat attacks or chest pain. There were not enough of these events for the panel to hold up the drug’s approval, but there was enough concern for them to recommend unanimously that studies be done to specifically look at heart risks.

Heart risks have been of greater concern with diabetes drugs since heart problems occurred with GlaxoSmithKline’s Avandia, which eventually caused the drug to be withdrawn from the market.

If approved, Novo intends to market degludec under the brand name Tresiba. The European Medicines Agency has already recommended approval and it has been approved for marketing in Japan.

Does losing weight help prevent heart attacks for people with type 2 diabetes?

Posted at 23rd October 2012 by Ryan Luce

written by Michael O’Leary

People with type 2 diabetes who maintained a weight-loss of 5 percent of their starting weight over four years saw improvements in blood sugar control, sleep apnea, mobility and HDL cholesterol.

Despite those benefits, however, researchers were surprised to find no difference in the rates of heart attacks, chest pain and death from cardiovascular causes between the exercise group and the comparison group of type 2 diabetes patients who did not lose weight.

As reported by the MedPage Today, the large federal study named Look AHEAD (Action for Health in Diabetes) was stopped two years early because the intensive program of weight-loss did not help with its main objective of reducing cardiovascular events.

But before you conclude there is no point in losing weight, the researchers caution that the reasons there was no difference between the two groups are unclear. Dr. Mary Evans, director of special projects at the National Institute of Diabetes and Digestive and Kidney Diseases suggested that it may be that people who volunteer for such a study, may be healthier to begin with than the general population with type 2 diabetes.

Dr. John Buse, director of the University of North Carolina’s diabetes center and former president of the American Diabetes Association, told the New York Times, that when they complete the analysis, it may be that the regular medications that both groups were taking before and during the study to reduce cholesterol and blood pressure may be so powerful as to overshadow the positive effects of weight loss and exercise on cardiovascular risk.

In the study, 5,145 overweight or obese people with type 2 diabetes were randomly assigned to either a strict diet and exercise program or to a comparison group that only received general health information in addition to usual care.

Patients had to have their blood pressure under at least moderate control (160/100 mmHg), HbA1c levels less than or equal to 11 percent, and fasting triglycerides concentration less than 600 mg/dL. The trial included those with and without a history of cardiovascular disease. Ages ranged from 45 to 76, and 60 percent were women.

The diet group was restricted to1,200 to 1,800 calories per day depending on their starting weight. In addition they participated in 175 minutes of moderate exercise per week.

After 11 years, the two groups had nearly equal rates of heart attacks, strokes and deaths from heart disease.

Research has shown that, on average, people with type 2 diabetes have a two-fold higher risk of heart disease than people without the disease. This study was designed to see if diet and exercise in these people would reduce their risk.

The results of the study will be analyzed to better understand the links between fitness, weight, diabetes control and heart disease risks.

Is Weight Loss Surgery the Best Option to Prevent Type 2 Diabetes?

Posted at 30th August 2012 by Ryan Luce

written by Michael O’Leary

In a study that could lead to changes in doctors’ recommendations about weight-loss surgery for people at risk for type 2 diabetes, researchers have shown that the procedure may be twice as effective in preventing the disease as lifestyle changes.

The Swedish study in this week’s New England Journal of Medicine compared 1,658 obese patients who underwent weight-loss (bariatric) surgery with 1,771 obese people who underwent usual treatment including diet and exercise. None of the patients in either group had been diagnosed with type 2 diabetes at the start of the study.

All of the men in the two groups had a body-mass index (BMI) of 34 or more and the women had BMI of 38 or more. A normal BMI ranges from 19-25, and obesity is defined as a BMI of 30 or higher.

Bariatric surgery includes several different types of surgery, but all of them essentially reduce the volume of the stomach, which restricts the amount of food that can be consumed. In this study, among patients who underwent the bariatric surgery, 19 percent had the banding surgery, 69 percent had the vertical-banded gastroplasty and 12 percent had gastric bypass surgery.

The researchers then followed these patients for 15 years, and over that time 392 participants in the usual care group developed type 2 diabetes compared to 110 in the bariatric surgery group.

As reported by ABC News, lead author of the study Dr. Lena Carlsson of the University of Gothenburg, Sweden, wrote that the results show that surgery may be more effective for some people in preventing type 2 diabetes.

“Bariatric surgery appears to be markedly more efficient than usual care in the prevention of type 2 diabetes in obese persons,” Carlsson wrote in the study.

While a single study is never enough to change clinical practice, this study offers enough compelling evidence to generate larger studies to see if these results hold up among bigger groups of people who are obese, but without type 2 diabetes. If it does it is possible that surgery might be recommended for more people to prevent them from developing the disease.

Some of the limitations of this study, are that 36.2 percent of the original participants dropped out of the study, and at the time of this analysis, nearly 31 percent had not been followed for the full 15 years.

It should also be noted that surgery does have risks, and in this study, the risk of death in the surgery group was two in 1,000 (0.2 percent) and 2.8 percent of the surgery group needed a second operation due to complications.

 

Why is Actos banned in France and Germany – but just made cheaper in U.S.?

Posted at 29th August 2012 by Ryan Luce

written by Michael O’Leary

Less than a week after France and Germany banned the use of pioglitazone, the FDA approved a generic version of the drug Actos for adults with type 2 diabetes.

As reported by Medpage Today, generic drug manufacturer Mylan Pharmaceticals was given approval for three dose levels of the drug, 15 mg, 30 mg and 45 mg. The approval comes just a year after the FDA approved updated labeling warning of bladder cancer risk for drug combinations using pioglitazone. The generic version will include the same warnings about heart failure and increased bladder cancer risk as the brand name versions.

Dr. Gregory Geba, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research indicated that the agency finds that the benefits outweigh the risks.

“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” Geba said in the FDA’s press release. “Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”

Pioglitazone is used with a diet and exercise and sometimes with other drugs, to treat type 2 diabetes. It works by increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels.

The package labeling warns that pioglitazone may cause or worsen heart failure, which is a condition in which the heart is unable to pump a sufficient volume of blood for the body’s needs. It also warns that using the drug for more than one year may be linked to a higher risk of bladder cancer. The FDA recommends doctors carefully monitor patients when starting the drug or increasing the dosage.

The FDA label also lists the most common side effects may include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat. Information about the availability of generic pioglitazone can be obtained from the manufacturer.

Pioglitazone belongs a class of drugs, called thiazolidinedione, or glitazones. AVANDIA, another glitazone, was severely restricted by the FDA two years ago. Medpage Today earlier reported that there have been suggestions that the bladder and heart effects may be common to all drugs of this class; more studies will be required, however, to determine that. In addition to the FDA, the European Medicines Agency and their Japanese counterpart have withheld further updates to the drug labeling pending additional reviews of the data.

 

Can Curry Help Prevent Type 2 Diabetes?

Posted at 7th August 2012 by Ryan Luce

written by Michael O’Leary

A supplement containing one of the ingredients in curry spice has been reported to prevent new development of type 2 diabetes among people at high risk for the disease.

The study, appearing July 29, 2012 in the journal Diabetes Care was widely reported by a number of major news outlets, including Reuters, USA Today, and MSNBC, among others.

The study was actually, fairly small and short, conducted by researchers at the Srinakharinwirot University in Nakomnayok, Thailand. It involved 240 Thai adults with prediabetes, who were randomly assigned to take capsules containing curcumin, or an inactive placebo six times a day for nine months. Prediabetes refers to elevated blood sugar levels that are not high enough to be defined as diabetes. People with prediabetes are at a greater risk for type 2 diabetes.

At the end of the nine months 19 of 116 of those in the placebo group had gone on to develop type 2 diabetes compared to none of 119 participants in the curcumin group.’

The researchers theorized that the supplement stimulated beta-cell function, the cells in the pancreas that produce the blood sugar-regulating hormone insulin.

While the results are promising, the study was much too small and spanned too short a time to drive anyone to their nearest health food store in search of curcumin.

For one thing, the study begs the obvious question, do people in India, where the spice is consumed daily have a lower rate of diabetes? A bit of internet searching suggests that the answer might be yes.

It turns out, not surprisingly that India and China have the world’s top two largest diabetes populations. The International Diabetes Federation (IDF) estimates that as many as 61. 3 million people in India are affected, when they add in those suspected to have undiagnosed prediabetes.

That works out to 8.3 percent of the Indian population estimated to have diabetes or prediabetes. By contrast, the IDF estimates10.94 percent of the U.S. population has been diagnosed with diabetes or prediabetes. Whether curcumin plays a role in that lower rate will take a lot more research.

Until more studies of curcumin are done, however, lead author of this study, Dr. Somiak Chuengsamam, an endocrinologist at the Srinakharinwirot University in Thailand, says that people at risk of type 2 diabetes should consider lifestyle changes.

“Prediabetes patients should be focused on diet and exercise as the first step,” Chuengsamarn said. “These practices have an obvious benefit in preventing type 2 diabetes in this group.”

New Data on Lantus is Promising

Posted at 17th July 2012 by Ryan Luce

At the 72nd American Diabetes Association (ADA) Scientific Sessions® last month, Eli Lilly and partner Boehringer Ingelheim presented data from two mid-stage (phase II) trials. In a press release from the two companies, the data presented showed that type 1 patients given the drug, code-named LY2605541, had lower daily average blood-sugar readings after eight weeks than those who received Lantus, and the reduction in HbA1c was greater among LY2605541 users than Lantus users.

In the other study of 290 type 2 patients, those taking LY2605541 had similar average daily blood sugar and HbA1c levels as those on Lantus, after 12 weeks of treatment.

In both studies, LY2605541 was associated with weight loss, while Lantus was associated with weight gain, which could be a key selling point. While the LY2605541 patients had a higher overall rate of low blood sugar episodes (hypoglycemia) than those on Lantus, the LY2605541 patients had a lower rate of nighttime hypoglycemia.

Dr. Richard Bergenstal, executive director, International Diabetes Center at Park Nicollet and clinical professor at the University of Minnesota was one of the investigators conducting the studies. He was encouraged by the results.

“As a clinical investigator, these Phase II results are intriguing, as they showed that LY2605541 improved glycemic control in patients with type 1 and type 2 diabetes,” Bergenstal said in the press release. “And produced additional effects, such as weight loss and less variability of blood glucose readings, both within the same day and between days.”

The companies said the data was sufficiently promising to move the study of LY2605541  into larger, late-stage (phase III) clinical trials, which could support a bid to seek regulatory approval for the product in 2014.