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 commissioning policies stop people with type 1 diabetes from gaining access to essential specialist services, medical experts have warned.

The proportion of people with diabetes who receive all essential checks is much higher for people with type 2 than type 1.

As a result, a disproportionately high number of patients with type 1 diabetes are receiving avoidable hospital treatment for failures of control.

According to the National Diabetes Audit, whereas 56.4% of patients with type 2 diabetes receive all nine NICE-recommended checks annually, only 38.5% of patients with type 1 diabetes do so.

In addition, the incidence of acute diabetic ketoacidosis in patients with type 1 diabetes is rising.

The reason, the Association of British Clinical Diabetologists said, is that type 1 diabetes (which always requires insulin therapy) needs a collaborative care pathway involving primary care and specialist teams.

Current NHS commissioning policy makes this difficult: payment by results attaches a specific cost to each referral, while the ‘Nicholson challenge’ is driving tighter referral management.

However, patients receiving specialist guidance to manage their insulin regimes better could avoid severe hypoglycaemia and ketoacidosis, as well as diabetic foot and eye damage.

Chris Walton, Chairman of the Association, said: “We would like specialist care to have more of a leadership role and to be more accountable. There are alternative ways of commissioning which should enable a more inclusive collaborative arrangement between specialists and generalists.”

For example, he argued, all patients with type 1 diabetes should have access to insulin pump provision; and all areas should have pathways to involve a specialist team when a severe episode of hypoglycaemia or ketoacidosis occurs.

Novartis’ Galvus (vildagliptin) has been approved for use by the European Commission for patients with type 2 diabetes who cannot take metformin, the current standard treatment.

The approval is based on data from clinical trials which assessed the drug as a monotherapy and found the treatment delivered improvements in glycaemic control, was generally well-tolerated and associated with a low risk of hypoglycaemia.

David Epstein, Head of Novartis, expects the brand to develop into a “blockbuster, we believe, quite soon”.

Galvus is already approved in the EU as an add-on treatment to metformin, sulphonylureas and thiazolidinediones. Towards the end of 2011, it received approval for patients with type 2 diabetes and moderate or severe renal impairment.

Last year it recorded sales of $677 million, an impressive increase of 66%, despite not being available in the USA. But it is the latest approval which has caused excitement at Novartis. The company estimates that more than 47 million Europeans have type 2 diabetes. It estimates this total will rise to 57 million people by 2030, with a quarter of these people unable to take metformin due to intolerance or contraindications.

A combination of a branded drug from Boehringer Ingelheim and Eli Lilly and a drug widely available in generic form has been shown in a phase III trial to be effective in treating type 2 diabetes.

Boehringer and Lilly’s Trajenta (linagliptin) in combination with metformin was shown to be more effective in controlling blood glucose levels than metformin alone.

Metformin, a successful glucophage drug for control of type 2 diabetes, was developed by Bristol-Myers Squibb and is now available in multiple branded and generic formulations.

Both drugs are used as monotherapies for type 2 diabetes in the UK, and some doctors already prescribe them together; but the new findings are likely to make the combination a standard treatment option.

The 24-week trial, part of a wider phase III study of the combination, showed that poorly controlled patients who received both drugs achieved an average reduction of 3.7% in HbA1c.

The drug combination was well tolerated, with only 9% of patients suffering side-effects and only 1.5% suffering hypoglycaemic events.

A previous one-year monotherapy trial had shown Trajenta to be of similar efficacy to glimepiride but with a significantly lower risk of side-effects, hypoglycaemic events and weight gain.

Trajenta is also the only approved diabetes medication with no need for dose adjustment in adult patients.

Professor Klaus Dugi, Corporate Senior VP of Medicine at Boehringer Ingelheim, said: “Many patients with high HbA1c levels require more than metformin alone to reach their blood glucose targets. Linagliptin can support patients with type 2 diabetes to effectively manage their condition.”

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.”