European Association for the Study of Diabetes 48th Annual Meeting

Insulin degludec lowers night-time hypoglycaemia
Insulin degludec, an experimental insulin, has been found to notably reduce the rate of dangerously low nocturnal blood glucose levels in adults with T2D. 

The ultra-long-acting basal insulin, developed by Novo Nordisk, also led to an equivalent improvement in glucose control over a period of 52 weeks compared with insulin glargine, marketed by Sanofi under the name Lantus^®.

Both medicines were given once daily to 1030 people with T2D who had not previously been treated with insulin. Insulin degludec was associated with noticeably lower rates of severe hypoglycaemia compared with insulin glargine. 

“Hypoglycaemia, and particularly night-time hypoglycaemia, is a major concern for people living with diabetes, and is the principal limiting factor to effective glucose control, thereby increasing the risk of long-term complications,” said Dr Helena Rodbard, lead author. She added, “The reduction in rates of nocturnal hypoglycaemia with insulin degludec will hopefully allay some of this concern and encourgage patients and physicians to aim for more ambitious glucose targets.”

Linagliptin is effective and well tolerated in T2D
Boehringer Ingelheim and Eli Lilly and Company have announced findings that Trajenta^® (linagliptin) is effective and well tolerated in people with T2D.

Results come from three pooled analyses of data from a large phase III study to assess the long-term safety and efficacy of linagliptin compared with placebo in 1261 participants whose diabetes was not adequately managed on basal insulin therapy. The overall safety and tolerability for linagliptin was found to be similar to that of placebo in people with T2D, including elderly people and people with diabetic nephropathy.

“Start Right, Eat Right” campaign promotes healthy diet and good nutrition
Sanofi Diabetes provided funding for a public nutrition drive that took place in Berlin and coincided with the 2012 EASD (European Association for the study of Diabetes) Annual Meeting. 

Professor Andreas Pfeiffer, of the Charité University, Berlin, showed his support of the campaign with a collection of “Quick tips for healthy living”, which were printed on 18000 leaflets handed out to attendees and the city’s general public as part of the “Start Right, Eat Right” initiative.

Apples were distributed to the public together with the leaflets in an effort to promote healthy eating.

Experimental compound demonstrates potential as an oral treatment for T2D
Empagliflozin, an experimental compound, has been put forward as a possible new therapy for people with T2D following results from a pooled analyses of phase IIb data for empagliflozin, undertaken by Boehringer Ingelheim and Eli Lilly and Company.

The study assessed the effect of empagliflozin on blood pressure, HbA_1c reduction and weight loss. 

Professor Michael Nauck, Head of the Diabeteszentrum Bad Lauterberg, Harz, Germany, who has published widely on diabetes, commented on the findings: “High blood pressure is an important contributor to higher cardiovascular death in people with T2D. Addressing elevated blood pressure should be an integral part of its management together with elevated blood glucose.”

Data show that sitagliptin lowers hypoglycaemia in the elderly with T2D
New data have shown a reduction in hypoglycaemia in elderly people with T2D who were given Januvia^® (sitagliptin; MSD) compared with those taking a sulphonylurea.

According to the research, carried out over a 12-month period, moderate-to-severe hypoglycaemia can affect almost half the people who have T2D in the UK. In 2012, the NHS spent nearly £10 billion on diabetes; 80% of this deals with potentially preventable complications of the disease. Each time a person is admitted to hospital due to severe hypoglycaemia, it costs the NHS around £1000.

“The general effects of ageing complicate the treatment of diabetes in the elderly. In particular, hypoglycaemia is of greater concern in this population and may lead to dizziness and accidents or falls, which are more likely to be dangerous,” said Dr Wasim Hanif, Consultant Physician, University Hospital Birmingham.

Global EDGE study shows effectiveness of vildagliptin in people with T2D
Novartis has announced new findings of a larger treatment response (in HbA_1c) with Galvus^® (vildagliptin) and Eucreas^® (vildagliptin/metformin) in people with T2D, when compared with a combined group of other oral antidiabetes treatments (including older and newer agents).

The observational data from the Novartis-sponsored EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study showed findings that are consistent with the efficacy and safety vildagliptin was found to have during clinical trials.

Phase III CANVAS trial: Canagliflozin is an effective add-on therapy in T2D
Use of the experimental medicine canagliflozin was found to significantly reduce blood glucose levels when used an add-on treatment in people with T2D considered at elevated risk for cardiovascular (CV) disease. 

The research is being carried out by Janssen Research and Development and is titled CANVAS (CANagliflozin cardioVascular Assessment Study). It comprises a prospective, double-blind, placebo-controlled trial to assess the efficiency, tolerability and CV safety of canagliflozin in 4330 participants with T2D. 

The data was from an 18-week sub-study of 1718 people with T2D. People taking part in the sub-study who were given canagliflozin on a daily basis, as well as their normal insulin treatment, showed greater HbA_1c reductions at 18 weeks compared with individuals who were taking placebo.

Phase IIb data on MSD’s experimental DPP-4 inhibitor MK-3102
MSD has unveiled data from its phase IIb study for the experimental weekly dipeptidyl peptidase-4 inhibitor (DPP-4) MK-3102. 

The agent is being developed to treat T2D. During the 12-week study, MK-3102 was found to notably reduce blood glucose compared with placebo. It was also associated with a similar rate of hypoglycaemic episodes compared with placebo.

Lead study author Ira Gantz commented on the findings: “If approved, MK-3102 would provide a novel, once-weekly treatment option to help reduce blood sugar levels in people with T2D.”

Many patient responses to hypos are inappropriate
Hypoglycaemic events present a huge challenge when it comes to glycaemic control of T2D using insulin. The GAPP2™ (Global Attitudes of Patients and Physicians) survey, which was funded by Novo Nordisk and carried out in six countries across Europe, Asia and North America, has concluded that hypoglycaemic events are very common in people with T2D who use an insulin analogue. This has a marked effect on how diabetes is controlled by patients and healthcare professionals.

The study found that many participants responded to hypoglycaemic events inappropriately. When such an event occurs, people often react by increasing blood glucose monitoring, and some deliberately maintain their blood glucose at a higher level than is acceptable or avoid these events by modifying their basal insulin dose. 

Exenatide once weekly linked to improved glycaemia and weight loss
Eli Lilly and Company has announced new data, which show that Bydureon^® (exenatide once weekly) is linked to improved glycaemic control with weight loss in T2D.

The pooled analysis from six studies showed improved glycaemic control with weight loss in people using a range of background therapies, and with varying baseline levels of blood glucose control. 

Jacek Kiljanski, Senior Medical Advisor within the European division of Diabetes Medical Affairs at Eli Lilly and Company said, “Importantly, these benefits were experienced by patients in association with reductions in cardiovascular risk markers and hypoglycaemia risks.”

Liraglutide: Results improve if used early on in T2D management
New analyses of data by healthcare company Novo Nordisk have shown that Victoza^® (liraglutide) is more effective when used early in the management of T2D. 

The data showed that people with diabetes are more likely to achieve an HbA_1c below 7% (53 mmol/mol) without weight gain or hypoglycaemia when they have a baseline HbA_1c below 8.5% (69 mmol/mol), have lived with diabetes for a shorter time (less than 4.9 years) and have received prior therapy with a single antidiabetes drug or a change to their diet.

The study retrospectively analysed data taken from seven phase III trials involving 1530 participants with T2D.

“We know from clinical practice that liraglutide is highly effective at controlling blood sugar levels, with the added benefit of weight loss,” said Dr Vanita Aroda, physician investigator from MedStar Health Research Institute, Hyattsville, MD, USA. She added, “These new results show an increased likelihood of achieving target glycaemic control (HbA_1c <7% [53 mmol/mol]), with no weight gain and no hypoglycaemia, when liraglutide is used earlier in T2D management.”

Diabetes specialists’ views on T2D management
A study has found that the once-daily glucagon-like peptide-1 inhibitor lixisenatide injected subcutaneously every morning notably postponed gastric emptying; this had a dramatic effect on PPG and blood glucose levels for the rest of the day and assisted overall glycaemic control.

The study findings coincided with results from a survey funded by Sanofi Diabetes that has found that seven out of 10 diabetes specialists view postprandial plasma glucose (PPG) as being as significant as fasting plasma glucose (FPG) for achieving target glycated haemoglobin levels in people with T2D. 

Out of 300 diabetes specialists surveyed, 80% indicated that it was necessary to establish new therapies to address high PPG concentrations for optimal glycaemic control, while 60% stated they were not aware of guidelines for monitoring PPG.

“The results of this survey support the growing body of evidence highlighting the importance of controlling PPG levels as a key part of the management of some patients with T2D,” said Dr Mike Baxter, Consultant Diabetologist and Endocrinologist at Runnymede Hospital, Surrey.

Diabetes therapy should be guided by the patient’s needs, values and preferences
Updated guidelines on T2D management by the EASD (European Association for the Study of Diabetes) and the ADA (American Diabetes Association) state that clinical decision-making should be propelled by individual patients’ needs, and offer advice on the rational approach to selecting therapy, encouraging increased patient involvement. 

The EASD and ADA stress that a patient-centred approach is the best way to provide healthcare for people with diabetes, and that treatment decisions should be made in response to the patient’s needs, values and preferences.

In the past, recommendations around the intensiveness of glycaemic therapy focused on a HbA_1c target below 7% (53 mmol/mol); the new guidelines are more practical and realistic, stating that individual goals should be established for each patient. The exact glycaemic target needs to address factors such as the person’s attitude and levels of cooperation, the predicted risk that is linked with the levels of glucose in the blood, and the duration of the disease.

The new guidelines also describe diet, exercise and education as factors that remain central to any T2D treatment programme.