Regular marijuana use reduces the risk of developing type 2 diabetes, according to a US study based on the National Health and Nutrition Survey.

Data for 2005–2010 show that people who reported recent marijuana use had 16% lower fasting insulin and lower insulin resistance.

The finding will strengthen the case for the medical use of marijuana, already licensed in 19 US states for use under conditions that avoid the health risks of smoking and excessive intake of the drug.

A synthetic form of its active ingredient, tetrahydrocannabinol (THC) is available in pill form and avoids the negative respiratory effects of smoking, as well as making doses easier to control.

The national survey covered 4,657 people. Participants answered questions about their drug use and gave fasting blood samples.

The link between marijuana use and markers of low type 2 diabetes risk (lower fasting insulin and insulin resistance) was stronger where the drug use was recent (within a month).

People with diagnosed type 2 diabetes were excluded from the data analysis, as their dietary patterns were likely to have been influenced by treatment.

Joseph S. Alpert, Editor-in-Chief of The American Journal of Medicine, commented: “We desperately need a great deal more basic and clinical research into the short- and long-term effects of marijuana in a variety of clinical settings such as cancer, diabetes, and frailty of the elderly.”

Janssen has submitted a Marketing Authorisation Application to the EMA for the approval of a fixed-dose therapy which would combine canagliflozin and immediate release metformin for the treatment of type 2 diabetes.

Canagliflozin is an investigational, oral medication for adult patients which blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

Metformin is a first-line pharmacotherapy which is used either alone or in combination with other medications, including insulin, to treat type 2 diabetes.

When combined, the fixed-dose therapy may offer adult patients a convenient medication in a single pill.

Janssen submitted a similar application to the US FDA for canagliflozin on 31 May 2012 and for a fixed-dose therapy combining canagliflozin and immediate release metformin on 12 December 2012.

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).

The UK now has more than three million people living with diabetes, new research claims.

Analysis carried out by the charity Diabetes UK and its partner Tesco found that 4.6% of the UK’s population has either Type 1 or Type 2 diabetes.

More worryingly, a further 850,000 people are thought to living with Type 2 diabetes without being diagnosed.

Barbara Young, Chief Executive of Diabetes UK, said the charity was “hugely concerned” at the findings and had “no reason to think this will mark the end of what has been a rapid rise in the condition.”

The new findings indicate an increase of some 132,000 people who have been diagnosed with the condition in the last 12 months. Every year in England and Wales around 24,000 people with diabetes die earlier than expected.

Experts have now warned that unless the precedence of diabetes is tackled the NHS will be burdened with unsustainable costs in the future.

“This unfolding tragedy is already putting huge pressure on the NHS and will have potentially devastating consequences for those people who develop the condition. But this is not inevitable,” said Barbara Young.

“By identifying those at high risk of developing Type 2 diabetes, we can ensure they start getting support to make the kind of lifestyle changes that can help prevent it. And by making sure people who have Type 1 or Type 2 diabetes are already getting the care and support they need, we can help them avoid the devastating complications diabetes can cause.”

Diabetes UK and Tesco have now established a new national partnership with the aim to raise £10 million to help create a healthier future for diabetics. The partnership will fund the largest public awareness campaign aimed at some seven million people thought to be at risk of contracting Type 2 diabetes.

“I’m delighted Tesco has made Diabetes UK its National Charity Partner, as this will make a real difference in curbing the rise in the condition,” said Barbara Young.

Novo Nordisk (NN) has celebrated 90 years of manufacturing and selling insulin for the treatment of diabetes.

The Danish company was the first to develop human insulin and the insulin pen for fixed dose injection.

It now produces half of the world’s insulin – a drug vital to all people with type 1 diabetes and many with type 2.

NN was founded by medical researchers August and Marie Krogh. August was a Nobel Prize winning zoologist and Marie was a doctor and diabetes patient.

In 1922, the couple went to Canada to meet Professor Macleod, the leader of the team who had discovered insulin. They gained permission to commercialise the drug in Scandinavia, and launched the company in early 1923.

Treatment innovations developed by NN include ‘modern’ insulins (genetically engineered insulin analogues with enhanced properties) and GLP-1, a type 2 diabetes drug than enhances the production and absorption of the body’s insulin.

In 2002, NN started the World Diabetes Foundation, an international funding agency supporting diabetes prevention and treatment in the developing world.

The company also manufactures biopharmaceuticals to treat haemophilia and growth disorders, and established the Novo Nordisk Haemophilia Foundation in 2005 to support patient care and treatment.

“Our 90 year anniversary is a significant milestone for Novo Nordisk. Our commitment to changing the lives of people with diabetes is unparalleled both globally and here in the UK, where we have been operating for over 25 years,” said Peter Meeus, NN’s UK Managing Director.

“Our researchers have discovered many breakthroughs in diabetes treatments for patients and our dedication to the training and support of NHS doctors and nurses has helped thousands to share expertise between primary and specialist care.”

Based in West Sussex, Novo Nordisk UK employs about 400 people.

GlaxoSmithKline (GSK) plans redundancies in its European sales and administration force to help it cut £1bn from its annual European, R&D and manufacturing costs by 2016.

The London-based pharma giant said it will achieve most of the cost reductions through technical improvements in its R&D and manufacturing processes.

According to CEO Andrew Witty, the cost savings plan has been driven by drug pricing pressures across Europe as the recession continues to worsen.

He also noted that job cuts would primarily affect sales and administration staff across Europe, but did not indicate the likely numbers.

Witty emphasised that GSK has six new drugs (including treatments for HIV, type 2 diabetes, melanoma and asthma) under review by regulatory bodies, with late-stage clinical trial data expected for another nine products within two years.

The company aims to launch up to 15 products within three years, he told business analysts. But given the economic uncertainties affecting Europe, 2013 would be a year of “twists and turns” and “not everything is going to go smoothly”.

According to a company spokeswoman, the technical and staffing changes (including redundancy payments) will have a combined one-off cost of £1.5bn, and will primarily be focused on Europe.

Taking insulin to control type 2 diabetes may increase the risk of developing serious complications, a new study suggests.

An epidemiological study based on the UK Clinical Practice Research Datalink (CPRD) has shown that type 2 diabetes patients taking insulin are at higher risk of heart attack, stroke, cancer and retinopathy than those taking oral medications.

The study follows a population-based study that showed people with type 2 diabetes treated with insulin had a 50% higher mortality rate than people treated with a widely prescribed alternative.

Researchers from Cardiff University’s School of Medicine used CRPD data, which covers about 10% of the UK population, to compare the mortality rates of people whose type 2 diabetes is treated in different ways.

Lead study author Professor Craig Currie noted that the use of insulin to control blood glucose levels in people with type 2 diabetes has grown “markedly” in recent years. However, he noted, “By reviewing data from CPRD between 1999 and 2011 we’ve confirmed there are increased health risks for patients with type 2 diabetes who take insulin to manage their condition.”

Type 1 diabetes requires treatment with insulin, but type 2 diabetes – which often occurs in older and overweight people – can be treated in a number of ways depending on the patient’s characteristics.

“This study shows that we need to investigate this matter urgently, and the drug regulatory authorities should take interest in this issue,” Professor Currie added.

A previous study of UK patients taking insulin to control type 2 diabetes found a 50% higher mortality rate than with an oral drug therapy.

However, it should be noted that those patients with type 2 diabetes put on insulin are likely to have the worst diabetes control prior to insulin therapy.

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.

NICE has requested further information on Forxiga (dapagliflozin) as a combination therapy option to treat type 2 diabetes after failing to recommend the product in draft guidance.

Bristol-Myers Squibb and AstraZeneca have been asked for further clarification and information after concerns were raised about trial data and the cost modelling of the drug.

Forxiga has a UK marketing authorisation in adults with type 2 diabetes mellitus. It’s used as monotherapy when diet and exercise alone do not provide adequate control and as an add-on combination therapy with other treatments, such as insulin and metformin.

During the appraisal, NICE’s independent Appraisal Committee questioned the evidence on the clinical effectiveness of Forxiga as an add-on to insulin and metformin.

The Committee noted that the trial data for the drug as an add-on therapy to insulin came from two placebo-controlled trials – one of which was only 12 weeks in duration. The evidence supplied for Forxiga as an add-on to metformin came from three clinical trials and a network meta-analysis.

Concerns were also raised by the Committee surrounding the comparisons made by BMS and AZ of the cost of Forxiga and with that of other anti-diabetic drug therapies and how these were initially made.

“Type 2 diabetes is a serious problem in the UK and it is important that there is a range of different treatment options available,” said Professor Carole Longson, Health Technology Evaluation Centre Director at NICE. “Unfortunately the Appraisal Committee is currently unable to recommend dapagliflozin, one of the options, for the treatment of this condition. They have requested further information from the manufacturer, which will be considered at the next Appraisal Committee meeting in April.”

Final guidance is expected in June 2013.

As the incidence of diabetes in the UK soars, the austerity NHS is increasingly unable to meet the needs of patients with this complex and lethal disease. How can the pharmaceutical industry help the situation?

Blindness. Foot and leg amputation. Kidney failure. These are among the complications of diabetes, a complex metabolic disorder that is now the leading health challenge facing western society.
In diabetes the absorption of glucose (sugar) from the blood fails, causing it to accumulate in the circulatory system. This occurs either because the pancreas stops producing the hormone insulin (type 1 diabetes) or because insulin production is inadequate or the body’s response to it is poor (type 2 diabetes).
Both types of diabetes have genetic risk factors, but type 2 or ‘mature onset’ diabetes has other risk factors such as age, obesity and lack of exercise. Type 1 or ‘juvenile onset’ diabetes is fatal unless the missing insulin is replaced by injection. In type 2 diabetes, a range of medications such as metformin can be used to improve glucose uptake.

The number of people diagnosed with diabetes in the UK has increased from 1.4 million in 1996 to 2.9 million in 2012, and continues to rise, with type 1 diabetes now accounting for only 10% of the total. The prevalence of type 2 diabetes has risen sharply, due to the ageing population and the trend towards obesity.

There is no cure for diabetes. A range of medications exist to treat it, but establishing the correct dosage levels is not easy: only an estimated 6% of diabetes patients get the balance right. Since no medication can make diabetes go away, the condition demands constant monitoring and medication adjustment, as well as checks for complications.

And at a time of deepening austerity in NHS funding, that level of attention to patient needs is getting harder to afford. All the signs are that people with diabetes (especially the more high-maintenance type 1) in the UK are at increasing risk of disabling or fatal complications. Sugar is killing more of us all the time.

High and dry
In November 2012, the Public Accounts Committee observed that diabetes care in England was “depressingly poor”, with 24,000 preventable deaths from the disease happening each year. The report pointed to a lack of clinical leadership and a ‘postcode lottery’ in diabetes care.

Barabara Young, Chief Executive of charity Diabetes UK, commented: “Given all the increasingly strong evidence of inadequate care, we simply cannot understand why the NHS has sleepwalked into this situation.”

During 2012, Diabetes UK drew attention to the need for better access to diagnostics, more referrals to specialist care, and wider awareness of the role of healthy lifestyle in preventing and controlling diabetes.
In April 2012, Young noted that 80% of NHS spending on diabetes care went on treating preventable complications. In May 2012, Diabetes UK stated that diabetes care in England was in a “state of crisis” with fewer than half of patients receiving adequate care.

Yet the medicines and diagnostics exist to reduce the incidence of diabetes, manage the condition and avoid complications. It’s not rocket science. What has gone wrong – and what is the solution?

A preventable crisis
Tracy Kelly, Head of Care at Diabetes UK, spoke to Pf about the problems of diabetes care. For the patient, she said, “Optimal diabetes control requires dedication and motivation from the individual to test, inject or take medication, adjust their dietary intake, potentially make lifestyle changes, monitor their condition and ensure they are receiving their health checks.”

This puts the patient under intense pressure, especially if they have other chronic conditions. How can the pharmaceutical industry help? In three ways, Kelly said: “Better provision of information and education for people with diabetes and for the healthcare professionals; commitment to research into new and improved treatments and monitoring approaches; and bridging the gap in healthcare services by supporting specialist nurses and dieticians in hospitals, for example with pump training and starting on insulin.”
Importantly, Kelly noted, the agendas of drug treatment and lifestyle change are not opposed: “There should always be a dual approach.” In treating both types of diabetes, clinicians need to look for the optimum blend of medication and lifestyle factors for each patient. The NHS needs to deliver programmes of risk assessment and early diagnosis; offer effective education in self-care for all patients; and ensure that they receive the nine regular checks recommended by NICE.

Working together
Successful diabetes care depends on integrating primary and specialist care, Kelly emphasised. “Effective diabetes care can only be achieved through integration. There must be clear referral plans in place and transparency about who does what and where specialist diabetes care is required. Specialist teams also have a key role to play in educating and supporting primary care.”

Cutting down on GP referrals is a growing NHS trend, praised by David Nicholson in his 2012 NHS review and promised in many CCG commissioning plans. Does this pose a threat to diabetes care? Kelly’s response was clear: “Cutting down referrals to specialist care may increase the risk of complications and could result in increasing costs to the health system. Diabetes is complex and any blanket rules to cut referrals could put lives at risk over the long term.”

For patients with type 1 diabetes, in particular, referral management is a recipe for trouble: “We know it is important for people with type 1 to have access to a team of specialists such as a dietician, podiatrist and counsellor. But often their access to this kind of support only comes once complications have developed.”
In short, drug manufacturers and healthcare providers can work together to support patients in avoiding complications – but clumsy cost-driven applications of QIPP are tending to disable care.

The hidden disease
As Louis MacNeice said, the North begins inside. Danish pharmaceutical company Novo Nordisk has specialised in diabetes care since its launch in 1923. Its insulin products (used by many type 2 as well as type 1 patients) are the standard of care in the UK. The company’s CEO, Lars Sorensen, recently observed: “What we are good at, all of a sudden becomes the biggest public health problem we have ever seen.”
Peter Meeus, Vice President, Novo Nordisk UK and Ireland, spoke to Pf about the company’s role in meeting the diabetes challenge. He noted that according to the National Diabetes Audit, only half of diagnosed patients in the UK are achieving treatment targets, while fewer than half of all people with diabetes receive all nine recommended healthcare checks.

Too often, Meeus noted, diabetes is only detected when secondary complications arise such as retinopathy and foot ulcers. Insulin can be the most effective treatment, but fear of injecting is sometimes a barrier to its adoption. As a result, “many patients start on insulin too late and are therefore at risk for developing serious late complications”. This is unfortunate, as the needles used today are much thinner and less painful.

Shot in the dark
According to Meeus, the pharmaceutical industry can help the NHS meet the challenge of diabetes by helping to identify the high proportion of diabetes patients who are poorly controlled, and to ensure these patients achieve control within the national guidelines.

He added: “Novo Nordisk is working with the DH and local health economies, together with physicians, to deliver agreed diabetes health outcomes at both national and local level, using appropriate innovative medicinal interventions as well as service design and support.” Specifically, the company provides Diabetes Education Nurse Facilitators to primary and secondary care organisations where needed, and its local Diabetes Outcomes Directors work to assist the redesign of diabetes services.

The company may owe its current growth in part to the growing incidence of diabetes, Meeus said, but its depth of experience in this therapy area has enabled it to take advantage of the opportunities: “Innovation and science have always been at the core of Novo Nordisk’s business, and as a result we today have the broadest portfolio of R&D diabetes projects. At a time when others in the pharmaceutical industry are cutting R&D budgets, we’re increasing our investment.”

“The challenge going forward,” he concluded, “is the fact that diabetes today is the biggest problem for healthcare systems, but at the same time the healthcare budgets are under increased pressure.” Diabetes UK and millions of patients would agree. But where there’s a will, there’s (sometimes) a way.