Novo Nordisk has launched Tresiba (insulin degludec), a new basal insulin for adults with type 1 or type 2 diabetes, in the UK.

Tresiba controls HbA1c levels as effectively as the standard basal insulin Lantus (insulin glargine) while posing less risk of nocturnal hypoglycaemic episodes.

It is also the first basal insulin to allow flexibility in injection time, as it has a 42-hour action, requiring only a minimum of 8 hours between injections.

Compared to Sanofi’s Lantus, Tresiba has been shown to reduce the incidence of nocturnal hypoglycaemia in patients with type 1 diabetes by 25%, and in insulin-naive patients with type 2 diabetes by 36%.

The overall rate of hypoglycaemia was similar for both types of insulin – but nocturnal episodes are particularly dangerous because they are harder to treat. Severe hypoglycaemic episodes are estimated to be responsible for 6% of deaths in people with diabetes under the age of 40, and half of such episodes take place at night.

Professor Melanie J Davies, Professor of Diabetes Medicine, University of Leicester, said: “Many of my patients have difficulty taking their insulin at exactly the same time each day, for reasons which we can all sympathise with and understand. For example, picking children up from school or working irregular shifts at work.

“It is thus very useful that there is now an insulin which, because of its longer duration of action, is able to offer patients a bit more flexibility in terms of timing of their dose without compromising either their glycaemic control or risk of hypoglycaemia.”

Tresiba is available in two FlexTouch pens: FlexTouch U100 (1–80 units per dose) and FlexTouch U200 (2–160 units per dose).

A new injectable drug has been approved for use in the EU to help control type 2 diabetes, alongside basal insulin or oral medication.

Lyxumia (lixisenatide) from Sanofi is the first once-daily prandial GLP-1 receptor agonist, a drug that stimulates the pancreas to produce more insulin during meals.

Licensed by Sanofi from Danish biotechnology company Zealand Pharma, Lyxumia can improve blood glucose control by reducing the ‘peaks’ induced by meals.

It is indicated for adjunctive use together with basal insulin or an oral glucose-reducing drug when these alone do not deliver effective control.

The approval was based on the GetGoal clinical trial programme, which involved more than 5,000 patients with type 2 diabetes and showed that Lyxumia achieved a marked post-prandial reduction in blood glucose and a significant long-term HbA1c reduction.

It also helped to reduce body weight, and its side-effects (nausea and vomiting) were short-lived. Risk of hypoglycaemia was limited.

“Patients with Type 2 diabetes are not all alike,” said Dr Filip K. Knop of Gentofte Hospital, University of Copenhagen. “One issue is that patients treated with basal insulin often move away from their target HbA1c despite well-controlled fasting plasma glucose.

“Adding a short-acting GLP-1 receptor agonist with a pronounced effect on post-prandial glucose, like once-daily Lyxumia, may be a good way of getting these patients back at target without increasing the risk of hypoglycaemia.”

Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA): it enhances the action of GLP-1, a naturally occurring peptide hormone that is released while eating a meal and stimulates insulin secretion by pancreatic cells.

Sanofi has in-licensed the drug from Zealand Pharma, who will receive low double-digit percentage royalties on global sales.

NHS diabetes care for children and young people is at its best in eight years, according to a major paediatric diabetes audit.

The audit found overall improvements in children’s HbA1c levels (a measure of blood glucose control) and the number receiving all eight recommended tests.

However, there has been a major increase in the number of children with diabetic ketoacidosis, and children’s care remains less effective than for adults.

The National Paediatric Diabetes Audit, conducted by the Royal College of Paediatrics and Child Health (RCPCH), surveyed 23,676 children and young people with diabetes in England and Wales.

It found that 6% had received all eight NICE-recommended tests (compared to 4% in 2009/10 and 2% in 2004/05) – by contrast, so had over 50% of adults with diabetes.

The percentage of children and young people with diabetes whose HbA1c levels are below the target (7.5%) was 16%, compared to 14.5% in 2009/10 – however, this compares poorly with the German figure (34%).

The audit also uncovered marked variation in children’s HbA1c levels across different care units, with the proportion of patients reaching the control target ranging from 2.9% to 33.8%.

Nearly a third of children and young people showed HbA1c levels above 9.5%, a dangerous level. Worse, the proportion diagnosed with ketoacidosis has increased from 8.5 to 15 per 100,000 since 2005, and this potentially lethal symptom is becoming more prevalent in female teenagers.

Dr Justin Warner, RCPCH lead, said: “Although the proportion of patients receiving all eight care processes remains low, what we’re seeing is improvements in the recording of all eight measures independently.

“Only with good data can we really start to make inroads into improving care for the infants, children and young people with diabetes in England and Wales.”

New NICE guidance recommends ‘stepped’ risk assessments for type 2 diabetes and early intervention in cases of high risk.

Risk assessments are recommended for adults aged over 40; adults aged over 25 in certain ethnic groups; and adults with conditions that increase the risk of diabetes.

Individuals at high risk should be offered a blood test and treated through an intensive lifestyle change programme that may include medication.

Diabetes affects an estimated three million people in the UK – predicted to rise to five million by 2025 – and type 2 diabetes accounts for 90% of the total.

NICE observes that individual risk of developing type 2 diabetes can be reduced by 60% through lifestyle changes including diet and exercise.

The new guidance recommends that risk assessments be offered to people (except pregnant women) in the following groups:

• adults aged 40 or over

• adults aged 25 or over who are of South Asian, Chinese, African-Caribbean or Black African origin

• adults with conditions that increase the risk of type 2 diabetes, including obesity, hypertension and mental illness.

Individuals considered at high risk should be offered a blood test (fasting glucose or HbA1c) at least once a year, and the correct level of intervention decided accordingly.

NICE recommends preventative measures such as diet and exercise regimes. Medications such as metformin (to improve insulin uptake) and orlistat (to assist weight loss) may be used to treat ‘pre-diabetes’.

As well as helping to prevent type 2 diabetes, these measures will help to diagnose the condition – it is estimated that 850,000 people in the UK have undiagnosed diabetes.

“We are not just seeing an epidemic of type 2 diabetes, it is a tsunami,” said Professor Kamlesh Khunti, chair of the NICE guidance development group.

Scottish diagnostic device company Axis-Shield has accepted a takeover bid by US ‘connected health’ specialist Alere three months after rejecting a slightly lower offer from the same company.

Alere is motivated to acquire Axis-Shield’s Afinion multi-parameter point of care testing devices, which compete with its US diagnostic products.

Axis-Shield rejected an offer of £230m from the US company in July but has now accepted an offer of £235m, an increase of only 2%.

The Dundee-based company blamed the “volatile economic and market backdrop” for its amended decision.

Alere took its second offer directly to Axis-Shield’s shareholders following the company’s rejection of its first offer.

Business analyst Mike Mitchell of Seymour Pierce commented that the increase in the offer was “not much more than a token gesture,” adding that “under more settled circumstances, the board may have considered to take a more robust position.”

Afinion, described by Axis-Shield as “a new concept in Point of Care”, is a multiparameter analyser device for on-the-spot testing of whole blood, plasma or urine samples for a range of characteristics including HbA1c and cholesterol.

Based in Massachusetts, Alere specialises in diagnostic testing systems for a range of conditions, supporting home-based healthcare through a ‘connected health’ strategy.

The CHMP has given a positive opinion to Novo Nordisk’s basal insulin analogue Levemir as an add-on treatment in patients with type 2 diabetes.

The opinion is based on a clinical trial where, as an add-on therapy to Victoza, in combination with metformin, reduced glycated haemoglobin (HbA1C) and sustained weight loss were demonstrated.

Alan Moses, Global Chief Medical Officer at Novo Nordisk, says the decision provides an “additional treatment option” for patients who need more options to achieve personalised glucose targets.

Meanwhile, the Committee has also adopted a positive opinion on the extended use of the insulin in children aged between two and five years old with type 1 diabetes.

It reviewed data that showed children treated with Levemir plus a fast-acting insulin analogue experienced a lower rate of all-day and nocturnal hypoglycaemia when compared to those taking human basal insulin and insulin aspart.

Dr Nandu Thalange, Norfolk and Norwich University Hospital, says that when treating children their safety must always come first and welcomed the CHMP’s decision. “Reducing risk of hypoglycaemia – particularly at night – is a vital part of modern management of young children with diabetes,” said Dr Thalange. “Children under six years are at the highest risk of severe hypoglycaemia and other acute diabetes complications, and any treatment which improves safety – not least in this group – is to be welcomed.”

Novo Nordisk now anticipates that the European Commission will shortly approve the usage of Levemir as an add-on therapy to Victoza in patients with type 2 diabetes and extend the marketing authorisation to make the insulin detemir the only basal insulin analogue for the use in this young patient group with type 1 diabetes.

Levemir, Victoza and NovoRapid, another insulin therapy by Novo Nordisk, contributed to a profit increase of 27% for the company in 2010.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

Boehringer Ingelheim and Eli Lilly have received Marketing Authorisation from the European Commission (EC) for its type 2 diabetes tablet Trajenta (linagliptin).

The EC has approved Trajenta in combination with metformin and metformin plus sulphonylurea after clinical trials involving approximately 6,000 adults showed it reduced haemoglobin A1c (HbA1c) levels.

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, says Trajenta has been shown to be a “reliable and efficacious treatment” for type II diabetes.

The tablet has also been approved for use as monotherapy in patients who have not responded to diet and exercise alone, and for whom metformin is inappropriate.

Unlike other DPP-4 inhibitors, Trajenta is primarily excreted unmetabolised via bile and gut which means there is no dose adjustment required for adult patients that may have declining kidney or liver function.

Professor Anthony Barnett, Consultant Physician, Heart of England NHS Foundation Trust and Emeritus Professor of Medicine, University of Birmingham, says that with Trajenta only available at a single 5mg dose, it is “convenient for physicians”.

“The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes,” said Enrique Conterno, President of Lilly Diabetes. “Linagliptin can be an important treatment option for people living with type II diabetes.”

Boehringer and Lilly began an alliance in January this year that centres on four pipeline compounds which represent several of the largest treatment classes in the field of diabetes.