Future Diabetics Show Elevated Blood Glucose Far in Advance

Patients who have been diagnosed with Type 2 diabetes can demonstrate elevated levels of glucose and glycated hemoglobin (HbA1c) even 10 years before their actual diagnosis.

Future Diabetics Show Elevated Blood Glucose Far in AdvancePatients who have been diagnosed with Type 2 diabetes can demonstrate elevated levels of glucose and glycated hemoglobin (HbA1c) even 10 years before their actual diagnosis, according to Esther van’t Riet, Ph.D., with the Department of Epidemiology and Biostatistics at VU University Medical Center in Amsterdam. Dr. van’t Riet presented the information at a poster session at the 47th annual meeting of the European Association for the Study of Diabetes (EASD). According to Dr. van’t Riet, individuals demonstrate moderate increases and then rapid increases in the few years prior to the diagnosis of diabetes, with increases in Hba1c often preceding elevated glucose.

Dr. van’t Riet and her research team used data from the Hoorn Study, a cohort of 565 Dutch participants, aged 50 to 75 at baseline in 1989 and with follow-ups in 1996 and 2000. None of the 565 participants had been diagnosed with diabetes at the beginning of the study.

At follow-up meetings, incident diabetes was diagnosed with the World Health Organization and American Diabetes Association’s 2011 criteria for the disease: fasting blood glucose levels of 7.0 mmol/L (126.1 mg/dL) or greater, or post-load glucose levels of 11.1 mmol/L (200mg/dL) or higher; and/or HbA1c levels of 6.5% or higher. Participants were categorized according to the status of their development of diabetes at baseline and follow-up.

At the 1996 follow-up, 99 of the study participants had developed incident diabetes; by 2000, an additional 48 had developed the disease. At the 2000 follow-up, 418 participants had still not developed diabetes. According to van’t Riet, the development of diabetes was preceded by elevated glucose and HbA1c levels in the years leading up to the diagnosis. “Those who developed diabetes already had elevated levels of glucose and A1c in 1989. So up to 10 years before diagnosis, we already see an elevation of all 3 glycemic measures,” she said. The third measure that the study analyzed was post-load glucose levels, which were obtained two hours into an oral glucose tolerance test.

“When we look at changes in time, we first compared those who never developed diabetes with those who had insulin diabetes in 1996. We see that all 3 glycemic measures show a steep increase from 1989 to 1996. After the diagnosis in 1996, they stabilize,” said Dr. van’t Riet.

The researchers also compared study participants who didn’t develop diabetes throughout the course of the investigation with those who had developed the disease in 2000. Those who developed diabetes saw increases in fasting glucose and post-load glucose between 1989 and 1996 that was “almost comparable for those who developed diabetes and those who never developed diabetes.” However, by 1996, those levels increased in the group that developed diabetes: “A steep increase is observed, which was not seen in those who never developed diabetes,” said dr. van’t Riet.

Unlike blood glucose levels, HbA1c levels did increase between 1989 and 1996 for those who later developed diabetes. “This might indicate that A1c increases earlier than glucose,” said Dr. van’t Riet.

The researchers performed further analysis on study participants with incident diabetes in 2000 who had increased HbA1c levels but lower glucose, and on those who had high glucose and normal HbA1c due to changes in the diagnostic criteria for diabetes.

“In those with diabetes based on high glucose, A1c levels tend to increase also. But in those with diabetes based on high A1c, glucose levels tend to stabilize in the follow-up period…. It might indicate that there are different developmental patterns according to the type of criteria you use,” continued van’t Riet.

A Good Night’s Rest Reduces Risk of Type 2 Diabetes

New research shows that getting eight and a half hours of sleep every night could reduce the risk of developing Type 2 diabetes in teenagers who are obese. The findings were published in the journal “Diabetes Care.”

A Good Night’s Rest Reduces Risk of Type 2 DiabetesDoctors have long extolled the health values of getting eight hours of sleep every night. Add another benefit to the list: new research shows that getting eight and a half hours of sleep every night could reduce the risk of developing Type 2 diabetes in teenagers who are obese. The findings were published in the journal “Diabetes Care.”

The study was conducted on 62 teenagers. The results demonstrated that insulin and blood sugar levels stayed at optimum levels for those who got between seven and a half and eight and a half hours of sleep at night. Getting more or less sleep increased the chance of elevated blood glucose levels; getting less than seven and a half hours of sleep resulted in lowered insulin levels.

According to the research team, which is affiliated with Children’s Hospital of Philadelphia, the results of the study demonstrate that healthy sleeping patterns could be beneficial in warding off diabetes in the participants of the study, who were all obese. The study was headed by Dr. Dorit Koren, who commented that the results corresponded with previous research showing that sleep-deprived adults were at a higher risk of developing Type 2 diabetes.

The study was conducted over a period of one and a half days. The teenagers’ blood sugar levels were monitored throughout the investigation, while their sleeping patterns were tracked and analyzed by the research team.

“Our study found to keep glucose levels stable, the optimal amount of sleep for teenagers is 7.5 to 8.5 hours per night,” said Dr. Koren.

The research team plans to conduct additional research, this time in the teenagers’ own homes rather than in a laboratory, to back up the results of the study.

“In the meantime, our study reinforces the idea that getting adequate sleep in adolescence may help protect against type 2 diabetes,” says Dr. Koren.

Research has shown that teenagers are not getting enough sleep. Another study previously conducted in 2007 showed that one in three British teenagers is getting just four to seven hours of sleep every night.

Another study conducted at the University of Buffalo and headed by Lisa Rafalson found that participants who were sleep-deprived were 4.5 times more likely to develop impaired fasting glucose, a condition that is considered a precedent to Type 2 diabetes. The study analyzed data from 1,455 volunteers over a period of six years; it measured how long the participants slept on average on weeknights. Participants who got less than six hours a night were four times more likely to develop impaired fasting glucose than participants who regularly got six to eight hours of sleep a night. The study’s findings were presented at the 49th annual Conference on Cardiovascular Disease Epidemiology of the American Heart Association in Palm Harbor, Florida.

“Our findings will hopefully spur additional research into this very complex area of sleep and illness,” said Rafalson. “While previous studies have suggested that there may be many genes that each have a very small effect on the risk of diabetes, there is no known genetic predisposition to sleep disturbances that could explain our study’s results, especially in this limited sample size. It is more likely that pathways involving hormones and the nervous system are involved in the association.”

It is speculated by some researchers that a lack of deep sleep is the source of the increased risk of diabetes: a shortage of slow-wave, or deep sleep, impairs the body’s ability to regulate blood glucose levels and increases risk of Type 2 diabetes.

Diabetes Linked to Alzheimer’s and Other Forms of Dementia

Individuals who had been diagnosed with diabetes were 74% more likely to develop some form of dementia over 15 years of follow-up.

Diabetes Linked to Alzheimer's and Other Forms of DementiaA longitudinal study conducted in Japan has shown that risk of dementia increases when glucose levels swing out of control, especially directly after meals. The study was conducted by Yutaka Kiyohara, M.D., Ph.D., and colleagues at the Kyushu University in Fukuoka, Japan. The results were reported in the September 20 issue of the journal “Neurology.”

Individuals who had been diagnosed with diabetes were 74% more likely to develop some form of dementia over 15 years of follow-up. The study also adjusted for confounding factors. The study followed 1,017 community-dwelling older adults who did not have dementia at the beginning of the study. The participants had an oral glucose test at age 60 or older; the researchers followed them for 15 years to determine if they developed one of the various forms of dementia.

Patients with diabetes were also 2.05 times more likely to develop Alzheimer’s than individuals with normal glucose tolerance levels, after adjustment for confounding factors. As such, diabetes was specifically associated with a higher risk of developing Alzheimer’s disease later in life.

According to Richard Bergenstal, M.D., with the International Diabetes Center at Park Nicollet in Minneapolis, MN, the study’s results were also interesting in that they displayed a strong risk prediction of Alzheimer’s associated with post-load glucose levels during the oral glucose tolerance test.

Patients who displayed higher blood glucose levels two hours after a meal were shown to be at a higher risk of developing dementia, including Alzheimer’s.

Study participants who showed a post-meal blood glucose measurement of 7.8 to 11.0 mmol/L had a 50% greater chance of developing all-cause dementia. Those with a post-meal blood glucose measurement greater than 11.0mmol/L had 2.47-fold increase in risk of all-cause dementia and a 3.42-fold increase in risk of Alzheimer’s.

According to Kiyohara’s research group, the findings demonstrated that “that postprandial glucose regulation is critical to prevent future dementia.” Individuals with diabetes need to manage their post-meal blood glucose levels carefully since they are at a greater risk of developing dementia later in life. “Our findings emphasize the need to consider diabetes as a potential risk factor for all-cause dementia, Alzheimer’s disease, and probably vascular dementia,” added Kiyohara’s group.

Bergenstal, a previous president of the American Diabetes Association, warned that it’s as yet unclear whether improved control of post-meal insulin levels could lower the risk of dementia for patients who already have diabetes. We need to understand it a lot better before we build this into our clinical practice,” said Bergenstal. “We don’t know yet from these studies how to intervene.”

Among the participants of the study, those who displayed diabetes through an oral glucose tolerance test were 2.07 times more likely to develop vascular dementia compared to those with normal glucose tolerance. The numbers were adjusted for age and sex.

The significantly higher risk of vascular dementia in diabetes patients may be a result of the low number of cases of that type of dementia, or because diabetes is associated with hypertension and other cardiovascular complications that are linked to vascular dementia.

Hyperglycemia may have also had an effect on the development of dementia by way of atherosclerosis, oxidative stress, the accumulation of advanced protein glycation, and changes in insulin metabolism that yield altered amyloid metabolism.

Diabetes and prediabetes accounted for 14.6% of all-cause dementia, 20.1% of Alzheimer’s disease, and 17% of vascular dementia risk. The research team noted that further studies were required before the results could be generalized to other ethnic populations.

Cellnovo Granted CE Mark Approval for Mobile Diabetes Management Technology

The system is composed of an insulin patch pump, a touch-screen handset equipped with a blood glucose monitor, and an extendable applications set.

Cellnovo Granted CE Mark Approval for Mobile Diabetes Management TechnologyCellnovo, a company working towards the development of new insulin delivery technologies, recently received CE Mark approval for its mobile diabetes management system, the first of its kind that the world has seen. The approval is an important milestone for Cellnovo in offering new, flexible technologies that aid diabetics in managing their disease.

“This is Cellnovo’s first step in a journey to bring this mobile diabetes management system to the world,” said William McKeon, Chief Executive Officer at Cellnovo.

The management system, also called Cellnovo, utilized mobile, wireless technology to aid diabetics in the management of their disease. The system is composed of an insulin patch pump, a touch-screen handset equipped with a blood glucose monitor, and an extendable applications set.

“Cellnovo has created the first insulin pump that brings innovation and combines form with function, essential qualities in a device that patients have to interact with 24/7,” said Dr. Pratik Choudhary, a Clinical Lecturer in Diabetes at King’s College London.

The patch pump developed by Cellnovo is the smallest and most precise one yet. The touch screen interface that the system uses will also be familiar and easy to navigate for anyone who has used a handheld mobile device such as an iPhone.

“Cellnovo has combined advanced mobile and medical technology which may create a paradigm shift in diabetes care,” according to Irl B. Hirsch, Professor of Medicine at the University of Washington in Seattle. “For the multitude of patients who could benefit from pump therapy, Cellnovo could be a game-changer.”

Perhaps the most innovative feature of Cellnovo’s diabetes management system is its ability to receive and transmit data wirelessly and in real-time to a portal that both patients and physicians have access to. The automated transmission of blood glucose data simplifies the process of keeping track of such information for patients, removing the need for diabetics to keep track of every measurement. It also ensures that the data is collected quickly, accurately, and consistently, allowing constant and efficient monitoring of the disease by health care professionals. This new capability could redefine the models that physicians use to treat diabetics, according to Dr. Mark Evans, a lecturer and Honorary Consultant with the Institute of Metabolic Science at the University of Cambridge.

“The ability to see real-time data of patients who may be hundreds of miles away provides the opportunity to redefine our care model,” said Dr. Evans.

Dr. David Kerr, a Consultant Physician and Diabetologist at Bournemouth Diabetes and Endocrine Centre, was also optimistic about the role that Cellnovo could play in revolutionizing diabetes care. “Cellnovo has the potential to break new ground in bringing the first mobile diabetes management system to market. It is clear that new technologies for diabetes care, such as Cellnovo’s mobile health solution, are going to forever change the way we practice medicine and more effectively manage diabetes long into the future.”

Cellnovo previously announced that it would be partnering with LifeScan, a Johnson & Johnson company based in California, to utilize LifeScan’s blood glucose monitoring technology with the Cellnovo mobile management system.

“We wanted superb blood glucose monitoring technology inside our mobile handset and LifeScan is a market leader,” said William McKeon, Chief Executive Officer of Cellnovo. “Through our partnership with LifeScan, our combined technologies will advance care through connectivity.”

Cellnovo is a mobile health technology company based in the U.K. Cellnovo’s goal is to utilize mobile technology to allow diabetics greater freedom and simplifying the process of insulin administration and glucose monitoring.

Relationship Between BPA and Diabetes Still Unclear

A recent study of 3,400 Chinese adults, age 40 and over, has found that exposure to bisphenol A is not associated with an increased risk of developing diabetes.

Relationship Between BPA and Diabetes Still UnclearA recent study of 3,400 Chinese adults, age 40 and over, has found that exposure to bisphenol A is not associated with an increased risk of developing diabetes. Bisphenol A is a chemical used in plastics that has been surrounded by controversy since some claimed it was responsible for health problems. The findings were published in the journal “Annals of Internal Medicine.”

The results of the study found that there was no correlation between levels of bisphenol A (better known as BPA) in the urine of study participants and their chances of having diabetes.

The 25% of the study participants with the highest urinary levels of BPA were found to have a higher risk of diabetes than those with a lower concentration of the chemical. However, the researchers did not find a “dose-response” relationship between BPA and diabetes — meaning that they did not discover any evidence that risk of developing diabetes increased as urinary BPA levels increased. The researchers said that, ultimately, they are unable to conclude whether there was a connection between BPA and diabetes.

Despite the research team’s findings, many are not convinced that they have put the issue to rest. Researchers outside the team have questioned the conclusions that they reached.

BPA is an endocrine disruptor: a chemical that can have a negative impact on normal hormonal activity in the human body. It’s also hard to get away from — it has been used for decades in the manufacture of hard plastics and linings for metal food and drink containers. Previous research has suggested that the large majority of Americans — about 95 percent — have some level of BPA in their blood.

Studies conducted recently on animals have suggested that BPA could contribute to certain types of cancer and heart disease and that it could affect neural development in children. Since the controversy around the chemical arose, the major manufacturers of bottles and cups for infants have stopped using it in the manufacture of those products.

Still, the effect of BPA on humans is unknown and remains controversial. In two large studies, elevated levels of BPA were found to be linked to increased risk of heart disease, while a study conducted in 2008 showed that individuals with higher BPA concentrations were at a higher risk of developing diabetes. Despite the associations, however, a causal relationship between the chemical and those conditions has not been proven — only a correlation.

The study analyzed data from 3,423 men and women; 32% of the participants had Type 2 diabetes. The participants were divided into four groups according to the levels of BPA in their urine. The group with the highest percentage of BPA was 37% more likely to have diabetes than the group with the lowest levels of BPA. However, the group with the second-highest concentrations of BPA showed no increased risk of diabetes while the next lowest group did show an increased risk.

Dr. Guang Ning with Shangai Jiao-Tong University School of Medicine, head of the study, stated that there was no “clear, monotonic relationship” between the presence of BPA and an increased risk of diabetes. “The evidence was not sufficient enough to declare an association,” said Ning.

However, an editorial published along with the study stated that the approach the researchers took was “idiosyncratic” because it all but dismissed the group with the highest levels of BPA and the highest risk of diabetes.

“It would be great to see the data released to the wider scientific community,” said Tamara Galloway, professor at the University of Exeter in the United Kingdom and an editorial writer for the study.

Diabetics Over 65 Less Aware of Hypoglycemia

A study conducted on elderly (over 65) patients who had been diagnosed with Type 2 diabetes found that they were not as aware of their own hypoglycemic conditions as were middle-aged (age 39-64) patients.

Diabetics Over 65 Less Aware of HypoglycemiaA study conducted on elderly (over 65) patients who had been diagnosed with Type 2 diabetes found that they were not as aware of their own hypoglycemic conditions as were middle-aged (age 39-64) patients.

The objective of the study was to determine the subjective responses of elderly patients to hypoglycemic episodes. Such patients are at a higher risk for severe episodes, but their subjective evaluations of their own blood glucose levels had not been previously evaluated. According to the researchers, hypoglycemia is the limiting factor in the management of diabetes, and there is increasing evidence that hypgoglycemic episodes are an important factor in the management of Type 2 diabetes.

The study examined 13 older (over age 65) patients and 13 middle-aged (age 39-64) patients who had been previously diagnosed with Type 2 diabetes. None of the patients demonstrated any symptoms of neuropathy, heart disease, a history of stroke, or overt nephropathy, and none of the patients had experienced a serious hypoglycemic episode that required the help of another person within the last year before the study took place.

Patients were administered insulin and dextrose intravenously, with the controls for the administration located outside the room so the patients would be not be able to tell that they were receiving the substances. The patients were required to fill out a semi-quantitative symptom questionnaire, rating the severity of eleven symptoms of hypoglycemia including dizziness, tingling, blurred vision, difficulty to concentrate, faintness, anxiety, palpitation, hunger, sweating, irritability, and tremor. Once they were finished answering the questionnaire, the patients were asked to estimate their current blood sugar levels.

Researchers had also measured the patients’ reaction times using a standard vigilance task, requiring them to identify changes in frequency of a sound by pressing a button as quickly as possible.

Upon analyzing the results of the study, researchers found that baseline blood glucose levels did not differ between the older and middle-aged group reached a hypoglycemic plateau faster than the older group did. Baseline concentrations of insulin were also similar between the two groups. The results did show that the older patients failed to perceive neuroglycopenic and autonomic hypoglycemic symptoms that the younger patients identified. The researchers stated that the differences in subjective evaluations of hypoglycemic symptoms were not caused by alterations in neuroendocrine counterregulation since the hormonal responses were similar across both age groups.

The authors believed that more studies would be necessary to identify the reason behind the differences, stating that “The mechanisms underlying the severe impairment of hypoglycemia awareness in our older patients cannot be derived from our data.” However, they speculated that the brains of older patients showed a diminished capacity for perceiving its own cognitive and physiological alterations due to hypoglycemia. They suggested that the results had important implications for Type 2 diabetics and that elderly diabetics may be more at risk for severe hypoglycemic episodes since they are less aware of their own hypoglycemic states.

The study was authored by Jan P. Breber, M.D., with the Department of Internal Medicine I at the University of Luebeck in Germany; Kamila Jauch-Chara, M.D., with the Department of Psychiatry and Psychotherapy at the University of Luebeck; Manfred Hallschmid, Ph.D., with the Department of Neuroendocrinology at the University of Luebeck. Corresponding author was Bernd Schultes, M.D., with the Interdisciplinary Obesity Center at Kantonsspital St. Gallen in Switzerland.

Vidagliptin (Galvus) Effective in Renally-Impaired Patients

Patients showed a statistically significant decrease in blood glucose levels when vidagliptin was added to other anti-diabetic therapies — 0.7% from baseline in patients with moderate renal impairment and 0.9% in patients with severe renal impairment.

Vidagliptin (Galvus) Effective in Renally-Impaired PatientsMutinational pharmaceutical company Novartis recently announced at the 47th annual Meeting of the European Association for the Study of Diabetes that results from a recent study demonstrated that Galvus® (vidagliptin) is similar in safety profile to placebo when it is used in conjunction with other anti-diabetic therapies in patients who have Type 2 diabetes and moderate to several renal impairment. The study, sponsored by Novartis, also showed that vidagliptin significantly improved glycemic control when it was added to current therapies.

Vidagliptin, a dipeptidyl peptidase-4 (DDP-4) inhibitor, is the largest of its type. It is used to treat patients with Type 2 diabetes with moderate to severe renal impairment, a condition known to be difficult to treat.

The study was randomized, double-blind, parallel-group, and placebo-controlled. It was conducted across multiple facilities and lasted 24 weeks. The study tested vidagliptin 50mg qd for safety and tolerability among 294 patients who had moderate renal impairment and 221 who had severe renal impairment. The groups were randomized, receiving either vidagliptin or placebo.

Researchers used glomerular filtration rate (GFR) to measure the renal function of the patients. Moderate renal impairment was defined as < 30 mL/min/1.73m while severe impairment was defined as 30 to < 50.

The data produced by the study showed that safety and tolerability of vidagliptin 50mg in patients with both moderate and severe renal impairment was typically similar to placebo.

Adverse events in patients with moderate renal impairment were similar in those receiving placebo and vidagliptin (68% and 73%, respectively), while serious adverse events registered at 9% in both groups. Only 3% of the patients on vidagliptin developed adverse effects leading to discontinuation of the medication compared to 5% on placebo; 1% of both groups died during the course of the study.

Adverse effects in patients with severe renal impairment were similar to moderate renal impairment patients at 73% on vidagliptin and 74% on placebo. 19% of the serious renal impairment patients taking vidagliptin experienced serious adverse effects compared to 21% on placebo; 2% of the vidagliptin patients died compared with 4% of the placebo patients.

Patients in the moderate renal impairment group who were treated with vidagliptin showed slightly higher rates of hypoglycemia, comparable to those in the severe renal impairment and placebo groups; this confirms a previous report that vidagliptin is associated with a low risk of hypoglycemia.

“Safety is the primary concern in the treatment of patients with renal impairment and this study demonstrated strong safety results with vidagliptin, without compromising on efficacy,” said Ameet Nathwani, M.D., Global Head of Cardiovascular and Metabolism Development Franchise with Novartis Pharmaceuticals. “Renally-impaired patients are a particularly vulnerable and high-risk T2DM population3 with limited therapeutic options.”

Patients with severe renal impairment who took vidagliptin displayed a higher rate of infections and infestations than patients taking placebo. Most of the adverse effects reported in the study were mild or moderate.

Patients showed a statistically significant decrease in blood glucose levels when vidagliptin was added to other anti-diabetic therapies — 0.7% from baseline in patients with moderate renal impairment and 0.9% in patients with severe renal impairment. The once-daily 50mg dose of vidagliptin was most effective in patients with average renal impairment; patients with normal renal function saw maximum efficacy from taking two daily doses of vidagliptin 50mg.

Vidagliptin is a DPP-4 inhibitor that prevents the breakdown of incretin hormones, which are responsible for stimulating insulin production in the pancreas. It targets the dysfunction in islet alpha and beta cells in the pancreas that causes increased blood sugar levels for those with Type 2 diabetes.

Linagliptin (Trajenta) Shows Positive Study Results

The findings demonstrated that linagliptin, a DPP-4 inhibitor, showed a positive safety profile in addition to reducing HbA1c levels by 0.8% over a long term period in patients who were treated with the medication for the entire duration of the study.

Linagliptin (Trajenta) Shows Positive Study ResultsA Phase III investigation of linagliptin (trade name Trajenta® in Europe) that lasted 102 weeks has shown significantly lowered blood glucose levels in adults who have been diagnosed with Type 2 diabetes. The results of the study were presented at the 47th yearly meeting of the European Association for the Study of Diabetes (EASD) by Boehringer Ingelheim and Eli Lilly and Company. The findings demonstrated that linagliptin, a DPP-4 inhibitor, showed a positive safety profile in addition to reducing HbA1c levels by 0.8% over a long term period in patients who were treated with the medication for the entire duration of the study.

The results showed not only the effectiveness of linagliptin, but its usefulness in the long term. “These results show that the efficacy achieved by linagliptin is reliable and meaningful in a clinical setting, but also that it is durable over the long term,” said Professor David Owens, Clinical Professor with the Department of Medicine at the Cardiff University School of Medicine in Wales, U.K. “This is especially important in chronic conditions such as type 2 diabetes.”

The data provided by the study demonstrates the effectiveness of linagliptin as well as the patients’ ability to tolerate it as a medication for Type 2 diabetes over a period of 102 weeks. Linagliptin was tested as a treatment by itself, as a dual treatment with metformin or pioglitazone, or as part of a multiple medication treatment along with metformin and sulphonylurea. After 24 weeks of blinded treatment, patients showed a reduction in HbA1c level of 0.8%; those results were durable, lasting throughout the remaining 78 weeks of the investigation. On average, the participants experienced a low incidence of hypoglycemic events while their body weight stayed about the same.

A separate investigation lasting 12 weeks demonstrated linagliptin’s effectiveness and durability when used as a dual medication in combination with metformin. The test used a group of patients who had been diagnosed with Type 2 diabetes and were taking uncontrolled metformin twice daily, a dose of 1500mg per day. The group was further split into two separate groups; one group took linagliptin 2.5mg twice daily — to simplify dosing, as the patients were already taking metformin twice daily — while the other group received linagliptin 5mg approved doses once daily. After adjusting for placebo, the results indicated that the two groups showed a comparable reduction in HbA1c, at 0.74% for the group taking linagliptin twice daily and 0.8% for the group taking the medication once daily.

“Linagliptin is a new treatment that is primarily excreted unmetabolised via the bile and gut, and so delivers reliable HbA1c reductions at one dosage strength for all patients, even for those with declining hepatic or renal function,” said Professor Anthony Barnett, a consultant physician with the Heart of England NHS Foundation Trust as well as Emeritus Professor of Medicine at the University of Birmingham in the U.K. “One dosage strength for all patients will help make the process of prescribing easier and more straightforward for physicians.”

The findings of the investigation demonstrate meaningful effectiveness of linagliptin, with good safety and tolerability markers, across patients with all types of Type 2 diabetes — from those who have been newly diagnosed with the disease to those with significant renal impairment.

Linagliptin was developed by Boehringer Ingelheim and is being marketed by Eli Lilly. Linagliptin inhibits DPP-4, an enzyme that degrades glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Harvard Launches The Healthy Eating Plate

The Harvard School of Public Health and Harvard Health Publications are two of the groups that have leveled criticism against the new “plate” initiative. In response, they have created the “Healthy Eating Plate,” their own version of the USDA’s food plate.

Harvard Launches Healthy Eating PlateThe U.S. Department of Agriculture has long held the food pyramid in high esteem as a recommendation for the types of foods we should be eating and their ratios to other foods. Within recent months, however, the USDA has redesigned its nutritional recommendations in the form of a plate, with portions of vegetables, grains, protein, fruit, and dairy represented as “slices of the pie.” The new dietary recommendations, detailed by the USDA at www.myplate.gov, was praised by some and criticized by others.

The Harvard School of Public Health and Harvard Health Publications are two of the groups that have leveled criticism against the new “plate” initiative. In response, they have created the “Healthy Eating Plate,” their own version of the USDA’s food plate.

According to Walter Willett, professor of epidemiology and nutrition as well as chair of Harvard School of Public Health’s department of nutrition, the USDA’s “My Plate” initiative is “simple,” but it might be “too simple.”

“It doesn’t have the details necessary to make healthy food choices,” said Willett. The lack of detail in the types of foods that we should aim for mean that you could follow the advice from My Plate and still eat a “horrible diet,” according to Willett. “It’s pretty useless.” In response to the perceived lack of detail in the USDA’s My Plate, Harvard’s Healthy Eating Plate is more specific about the types of food that are being recommended.

As with the USDA’s plate, half of Harvard’s plate is made up of fruits and vegetables, with slightly more vegetables than fruit. However, the Harvard plate specifically notes that potatoes don’t count as vegetables in this situation — Harvard researchers recently conducted a study that associated potato consumption with increased weight gain over a long period of time.

Harvard Launches Healthy Eating Plate

The “grain” section is more clearly defined to mean “whole grains” such as brown rice, whole wheat bread and whole grain pasta instead of refined and processed grains such as white rice and bread. The “protein” area of the plate is also more specifically defined as “healthy proteins,” including poultry, beans, fish, and nuts, which limits consumption of red meat and recommends cutting out processed meats, bacon, and cold cuts entirely.

A glass of milk has long been held as a healthy drink, but the Harvard Healthy Eating Plate eliminates the serving of dairy that the USDA’s plate recommends, instead encouraging people to drink a glass of water, tea, or lightly-sugared coffee. According to Willett, the Healthy Eating Plate only has room for one or two servings of dairy per day.

The Harvard diet includes a bottle of oil to the side of the plate to represent the healthy unsaturated fats found in foods like olive oil. According to the Harvard plate, we should limit butter while trans fats should be eliminated completely. According to Willett, the USDA plate does not provide enough detail about “the type of fat that should be used when we put something on our bread, on our vegetables [or] when we bake or cook,” says Willett.

The Myplate.gov initiative seeks to simply the sometimes complicated process of choosing a healthy diet. Among the no-nonsense recommendations are eating less and avoiding oversized portions, eating at least half of your grains as whole grains, and drinking water instead of sugary drinks.

Treatment with Insulin Alone Associated with Increased Mortality, Complications

Patients with type 2 diabetes who are taking insulin are at a very high risk after cardiac angiography, especially if they have a history of previous myocardial infarction or renal complications.

Treatment with Insulin Alone Associated with Increased Mortality, ComplicationsA registry analysis reports that patients who had been diagnosed with Type 2 diabetes and used insulin therapy to manage the disease were 19% more likely to die after a percutaneous coronary intervention than were diabetics who managed the disease through oral antiglycemic medication or with diet.

Even after researchers adjusted the results to account for the severity of the diabetes, the results remained the same. The findings were reported by Dr. Anna Norhammar with the Karolinska Institute of Sweden at the yearly meeting of the European Association for the Study of Diabetes.

“Patients with type 2 diabetes who are taking insulin are at a very high risk after cardiac angiography, especially if they have a history of previous myocardial infarction or renal complications,” said Dr. Norhammar. “We need to give these patients special attention and intensive handling.”

Dr. Norhammar’s research team used data on patients from two Swedish registries: the Swedish Coronary Angiography and Angioplasty Register (SCARR), which indexes all patients who have undergone those procedures, and the National Diabetes Registry, which holds data on about 70% of the Swedes diagnosed with diabetes. The research team identified 14,079 patients who had been indexed in both registries from 2001 through 2009; these patients were used to find the results of the study.
Patients were separated into four groups according to the type of treatment they received: those treated with diet alone, those treated with oral medications alone, those treated with insulin and oral medications, and those treated only with insulin.

The mean age of the patients was 69 years. The patients taking insulin only had the disease for an average of 15 years, while the patients who were being treated with therapies other than insulin had the disease for an average of 6 years.

Mean hemoglobin A1c in the patients rose along with the intensity of the treatment, from 6.5% in the group treated with diet to 7% in the group treated with oral medication to 7.8% in the groups treated with only insulin or with oral medication and insulin. The diet-only group had a 13% chance of developing retinopathy, compared to a 54% chance in the insulin-only group.
The insulin-only group also saw increased rates of heart failure (24%) compared to the other groups; the diet-only group was at 14% while the oral medication-only group was at 12% and the combination therapy group was at 17%. A significant number of the insulin-only group (39% of the patients) had suffered heart attacks while 29% of the diet-only group had such heart failure.

About 70% of the patients had been diagnosed with hypertension. The group treated with only insulin had a greater chance of developing renal insufficiency and peripheral artery disease, but the numbers were not statistically significant.

The patients’ angiographic results also varied according to the type of treatment they received. Of the patients treated with diet only, 22% had normal angiographic results; 17% of the insulin-only group had normal results. The insulin-only group had a higher rate of three-vessel disease, with 30% of the group developing the disease while only 23% of the diet-only group did the same.

After six months of treatment, the mortality rate was higher for the insulin-only group at 9%. Less intensive therapies indicated lower mortality rates, with the diet-only and oral medication group experiencing a 5% mortality rate and 7% for the combination therapy group.

By the four year mark, mortality in the insulin-only group was at 22% while the diet only group was at 15%; at the eight year mark, the insulin-only group’s mortality rate was over 50% while only 38% of the diet-only group had died.

Dr. Norhammar says it is unclear whether insulin-only treatment is directly responsible for the greater risks of disease and mortality or if it is simply a sign that the patient has a more advanced disease, which is likely to cause more complications and mortality.