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NICE recommends liraglutide for type 2 diabetes mellitus

In draft guidance published today (10 September 2010), NICE recommends liraglutide[[1]] (Victoza, Novo Nordisk) 1.2 mg daily for some people with type 2 diabetes mellitus. However, it does not recommend liraglutide at 1.8mg daily, as the available evidence does not suggest any significant additional benefit with the higher dose.

Liraglutide 1.2 mg daily in dual therapy regimens (in combination with metformin or a sulphonylurea) is recommended as an option for the treatment of people with type 2 diabetes, only if:

  • the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated, and
  • the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated.

As part of triple therapy regimens, liraglutide 1.2mg daily is recommended (in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione[2]) only when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual). The patient being treated must also have either:

  • a body mass index (BMI) of ≥ 35kg/m2 (in those of European descent, and appropriate adjustments made for other ethnic groups), and specific psychological or medical problems associated with high body weight, or
  • a BMI ≤ 35 kg/m2, where insulin therapy would have significant occupational implications, or weight loss would benefit other significant obesity-related comorbidities.

Treatment with liraglutide 1.2 mg daily should only be continued if the person's diabetes has shown a beneficial metabolic response; defined as a reduction of at least 1% in HbA1c at 6 months for dual therapy regimens, and for triple therapy regimens, defined as a reduction of at least 1% in HbA1c and a weight loss of at least 3% of initial body weight at 6 months.

However, NICE does not recommend liraglutide 1.8mg as a treatment option for people with type 2 diabetes. The independent Appraisal Committee thought that because the clinical data showed that there was only a marginal benefit[[3]] from using the higher dose of liraglutide 1.8mg compared with liraglutide 1.2mg, (and no clinical trial has evaluated the effects of dose escalation with liraglutide from 1.2 mg to 1.8 mg), treatment with the higher dose was not justified.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: "There are about 2.5 million people in the UK living with diabetes - 90% of whom have type 2 diabetes[4]. It is a serious, progressive disease, and so we are pleased to be able to recommend liraglutide 1.2 mg daily as a clinically and cost effective treatment option for some patients with type 2 diabetes. We were unable to recommend use of the higher dose however, as the available evidence does not suggest any significant additional benefit."

NICE has not yet issued final guidance to the NHS; these decisions may change after appeal.

Final guidance is likely to be published in October 2010.

Ends.

Notes to Editors

About the appraisal

  • Consultees can appeal against the decisions in this final appraisal determination guidance (FAD).
  • If there are no appeals, the recommendations in this FAD will be issued as guidance.
  • View the Type 2 diabetes: newer agents (partial update of CG66), NICE clinical guideline 87 (2009).
  • Liraglutide is administered once daily as a subcutaneous (under the skin) injection. The recommended starting dosage is liraglutide 0.6 mg daily. After at least 1 week, the dose should be increased to 1.2 mg. The summary of product characteristics states that, based on clinical response, after at least 1 week the dose can be increased to 1.8 mg. Daily doses higher than 1.8 mg are not recommended.
  • Liraglutide is available in a prefilled, disposable pen device comprising a pen injector and cartridge. The pen holds 3 ml of solution and contains 18 mg of liraglutide. Each pen holds 30 doses of 0.6 mg, 15 doses of 1.2 mg, or 10 doses of 1.8 mg. It is available in two pack sizes: 2 x 3 ml prefilled pens (£78.48), and 3 x 3 ml pens (£117.72) (British National Formulary [BNF 59] March, 2010). The drug costs for liraglutide as reported by the manufacturer are £2.62 and £3.92 per day (1.2 mg dose and 1.8 mg dose, respectively), and £954.84 and £1432.26 per year (1.2 mg dose and 1.8 mg dose, respectively). Costs may vary in different settings because of negotiated procurement discounts.
  • The most frequently reported adverse effects of liraglutide are gastrointestinal, including nausea, diarrhoea, vomiting, constipation, abdominal pain, and dyspepsia (indigestion). These gastrointestinal adverse effects may occur more frequently at the start of treatment with liraglutide, and usually diminish within a few days or weeks on continued treatment. Hypoglycaemia (low blood sugar) is also common, especially so when liraglutide is used in combination with a sulphonylurea.

About NICE

  • The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
  • NICE produces guidance in three areas of health:
  1. public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.
  2. health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS.
  3. clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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[1] Liraglutide works by stimulating the release of insulin; it also reduces the appetite and therefore food intake by slowing gastric emptying.

[2] Metformin, sulfonylurea and thiazolidinedione are other classes of drugs that are used in the management of type 2 diabetes mellitus, and lower glucose levels in the blood.

[3] The Committee noted that the results of a meta-analysis presented in the Evidence Review Group (ERG) showed no significant difference between liraglutide 1.2mg and liraglutide 1.8mg in terms of patients reaching an HbA1c level of less than 7%.

This page was last updated: 08 September 2010

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.