Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme

  1. B. Zinman1,*,
  2. W. E. Schmidt2,
  3. A. Moses3,
  4. N. Lund4,
  5. S. Gough5

Article first published online: 30 OCT 2011

DOI: 10.1111/j.1463-1326.2011.01493.x

Issue

Diabetes, Obesity and Metabolism

Diabetes, Obesity and Metabolism

Volume 14, Issue 1, pages 77–82, January 2012

Additional Information

How to Cite

Zinman, B., Schmidt, W. E., Moses, A., Lund, N. and Gough, S. (2012), Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes, Obesity and Metabolism, 14: 77–82. doi: 10.1111/j.1463-1326.2011.01493.x

Author Information

  1. 1

    Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada

  2. 2

    St Josef-Hospital, Ruhr-University Medical Faculty, Bochum, Germany

  3. 3

    Novo Nordisk Inc, Princeton, NJ, USA

  4. 4

    Novo Nordisk A/S, Søborg, Denmark

  5. 5

    Oxford Centre for Diabetes, Endocrinology and Metabolism, and NIHR Oxford Biomedical Research Centre, Churchill Hospital, Oxford, UK

*Dr. Bernard Zinman, Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, 60 Murray Street, Suite L5-024, Mail Box 17, Ontario, Canada M5T 3L9. E-mail: zinman@lunenfeld.ca

Publication History

  1. Issue published online: 14 DEC 2011
  2. Article first published online: 30 OCT 2011
  3. Accepted manuscript online: 22 AUG 2011 03:56PM EST
  4. Date submitted 14 April 2011; date of first decision 15 May 2011; date of final acceptance 17 August 2011

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Keywords:

  • GLP-1;
  • incretin therapy;
  • liraglutide;
  • type 2 diabetes

Aim: Effective type 2 diabetes management requires a multifactorial approach extending beyond glycaemic control. Clinical practice guidelines suggest targets for HbA1c, blood pressure and lipids, and emphasize weight reduction and avoiding hypoglycaemia. The phase 3 clinical trial programme for liraglutide, a human glucagon-like peptide 1 analogue, showed significant improvements in HbA1c and weight with a low risk of hypoglycaemia compared to other diabetes therapies. In this context, we performed a meta-analysis of data from these trials evaluating the proportion of patients achieving a clinically relevant composite measure of diabetes control consisting of an HbA1c <7% without weight gain or hypoglycaemia.

Methods: A prespecified meta-analysis was performed on 26-week patient-level data from seven trials (N = 4625) evaluating liraglutide with commonly used therapies for type 2 diabetes: glimepiride, rosiglitazone, glargine, exenatide, sitagliptin or placebo, adjusting for baseline HbA1c and weight, for a composite outcome of HbA1c <7.0%, no weight gain and no hypoglycaemic events.

Results: At 26 weeks, 40% of the liraglutide 1.8 mg group, 32% of the liraglutide 1.2 mg group and 6–25% of comparators (6% rosiglitazone, 8% glimepiride, 15% glargine, 25% exenatide, 11% sitagliptin, 8% placebo) achieved this composite outcome. Odds ratios favoured liraglutide 1.8 mg by 2.0- to 10.5-fold over comparators.

Conclusions: As assessed by the composite outcome of HbA1c <7%, no hypoglycaemia and no weight gain, liraglutide was clearly superior to the other commonly used therapies. However, the long-term clinical impact of this observation remains to be shown.

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