Scottish Medicines Consortium approve 'Januvia'®▼ (sitagliptin) for the treatment of type 2 diabetes

8 October 2007: The Scottish Medicines Consortium (SMC) announced today that sitagliptin (100mg) has been accepted for restricted use within NHS Scotland for treatment of patients with type 2 diabetes mellitus, to improve glycaemic control.

Sitagliptin (Januvia®) is accepted for restricted use within NHS Scotland for treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control. It should be restricted to use in patients only when the addition of sulphonylureas is not appropriate, and represents an alternative to other agents such as thiazolidinediones.

Efficacy, as assessed by measurement of HbA1c, is similar to sulphonylurea and thiazolidinedione drugs added at this stage in therapy. It appears to have minimal effects on body weight.1

Professor Andrew Morris, Professor of Diabetic Medicine at the University of Dundee, commented on the SMC decision, saying, “This provides NHS Boards, Area Drug and Therapeutic Committees, and healthcare professionals in Scotland with consistent and clear guidance on the role of sitagliptin in type 2 diabetes. It offers a new treatment approach that can be added to existing treatment regimes to help patients gain more control of their blood sugar levels. This will be of help to our ongoing battle against diabetes in Scotland.”

There are nearly 150,000 people in Scotland with type 2 diabetes,2,3 and it is predicted this figure will increase rapidly over the next five years4. Recent research has shown that Scotland is second only to the US in terms of levels of obesity5, which is of particular concern considering that 20 percent of all type 2 diabetes cases in Scotland are linked with obesity2,3 5.

Currently, despite pharmacological intervention, approximately two-thirds of adults with type 2 diabetes in the UK are not reaching recommended levels of glycaemic control6. Diabetes costs the NHS approximately £150,000 every hour, with the majority spent on treating complications.7

Professor Anthony Barnett, Birmingham Heartlands Hospital, comments, “Many patients fail to achieve adequate diabetes control putting them at increased risk of long term complications. This is in part contributed due to limitations of current therapies and concerns about weight gain and hypoglycaemia, as well as tolerability issues. It is excellent news that we now have another class of oral agents to increase the choice of compounds for our patients, particularly since sitagliptin appears to have an excellent tolerability profile with weight neutrality and very low risk of hypoglycaemia."

Sitagliptin, a once daily oral treatment, is the first in a new class of type 2 diabetes therapy, called DPP-4 inhibitors. It was licensed in the UK in April 2007 and has been prescribed in over one million prescriptions globally and works with the body's own way of controlling blood glucose, by increasing levels of gut hormones found naturally in the body, called incretins.

- ends –

To view the SMC recommendation, please go to:

For further information, please contact:

Georgie Griffith / Francesca McNeil

Cohn & Wolfe

Office: 020 7331 5369 / 5350

Louise Barr / Helen Wright

Merck Sharp & Dohme Limited

Office: 01992 452126 / 467272

Notes to editors

The Scottish Medicines Consortium (SMC) provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licenced from January 2002). This advice will be made available as soon as practical after the launch of the product involved. The remit of SMC excludes the assessment of vaccines, branded generics, non-prescription-only medicines (POMs), blood products, plasma substitutes and diagnostic drugs. The review of device-containing medicines will be confined to those licensed as medicines by the MHRA/EMEA.

For full prescribing information, including Clinical Particulars and Pharmacological Properties, please refer to the Summary of Product Characteristics included in this press kit. If the SPC is missing, please contact any of the individuals listed at the end of this release for a copy.

'Januvia'® is a Registered Trademark of Merck & Co., Inc., Whitehouse Station, New Jersey, USA

Merck Sharp & Dohme Limited (MSD) is the UK subsidiary of Merck & Co., Inc., of Whitehouse Station, New Jersey, USA, a leading research-based pharmaceutical company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health.


  1. SMC website
  2. Diabetes UK web site. What is Diabetes? (Accessed February 2007)
  3. Diabetes UK. State of the Nation Report (2006)
  4. Diabetes UK web site. Diabetes UK Scotland Manifesto 2007 Consultation (Accessed September 2007)
  5. Obesity in Scotland; An epidemiology briefing: ScotPHO Public Health Information for Scotland 2007
  6. Saydah SH, et al. Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed Diabetes. JAMA 2004; 291:335–342
  7. Wanless D. Securing our Future Health: Taking a long-term view. Final report. HM Treasury. April 2002. Chapter 2. Page 25. Section 2.49. (This figures is calculated from an annual cost of £1.3 billion)

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