Diabetes (type 2) - dapagliflozin [ID427]

Dapagliflozin for the treatment of type 2 diabetes

Status: History
Expected date of issue: June 2013
Process: STA

Scoped as part of Batch 21

Topic area:
  • Endocrine, nutritional and metabolic

NICE project team

Executive Lead: Andrew Dillon
Technical Lead: Matthew Dyer
Communications manager: Shalu Kanal
Project manager: Bijal Joshi


Provisional schedule

Closing date for invited submissions / evidence submission: 17 July 2012
1st appraisal committee meeting: 08 January 2013
2nd appraisal committee meeting 05 March 2013
3rd appraisal committee meeting: 09 April 2013


Consultees and commentators



Commentators (no right to submit or appeal)



  • Bristol Myers Squibb and AstraZeneca (dapaglifozin)

Patient/carer groups

  • Afiya Trust
  • Black and Ethnic Minority Diabetes Association
  • Black Health Agency
  • Diabetes Research & WellnessFoundation
  • Diabetes UK
  • Equalities National Council
  • Insulin Dependent Diabetes Trust
  • Insulin Pump Therapy (INPUT)
  • Insulin Pumpers UK
  • Muslim Council of Britain
  • Muslim Health Network
  • Network of Sikh Organisations
  • South Asian Health Foundation
  • Specialised Healthcare Alliance
  • Surya Foundation

Professional groups

  • Association for the Study of Obesity
  • Association of British Clinical Diabetologists
  • Association of Diabetes Specialist Nurses
  • British Association for Services to the Elderly
  • British Geriatrics Society
  • British Society for Paediatric Endocrinology & Diabetes
  • Diabetes Monitoring Forum
  • Diabetes Specialist Nurses
  • National Diabetes Nurse Consultant Group
  • National Pharmacy Association
  • Primary Care Diabetes Society
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians
  • Royal Pharmaceutical Society
  • Royal Society of Medicine
  • Society of Endocrinology
  • United Kingdom Clinical Pharmacy Association


  • Department of Health
  • NHS Gloucestershire
  • NHS Middlesbrough
  • Welsh Government


  • Board of Community Health Councils in Wales
  • British National Formulary
  • Care Quality Commission
  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • Diabetes UK Cymru
  • Healthcare Improvement Scotland
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • National Association of Primary Care
  • NHS Alliance
  • NHS Commercial Medicines Unit
  • NHS Confederation
  • Public Health Wales NHS Trust
  • Scottish Medicines Consortium

Comparator manufacturers

  • Actavis UK (glipizide, metformin, tolbutamide)
  • Almus Pharmaceuticals (metformin, tolbutamide)
  • Aurobindo Pharma (glipizide, metformin)
  • Boehringer Ingelheim and Lilly Uk (linagliptin)
  • Bristol laboratories (metformin)
  • Bristol Myers Squibb, AstraZeneca (saxagliptin)
  • Eli Lilly (exenatide, insulin)
  • Goldshield (metformin)
  • Kent Pharmaceuticals (glibenclamide, glimepiride, metformin, tolbutamide)
  • Merck Sharpe and Dohme (metformin, sitagliptin)
  • Mylan (glimepiride, glipizide, metformin, tolbutamide)
  • Novartis Pharmaceuticals UK (metformin, vildagliptin)
  • Novo Nordisk (insulin, liraglutide)
  • Pfizer (glipizide)
  • Sanofi Aventis (glimepiride, insulin)
  • Somex Pharma (glimepiride)
  • Takeda (metformin, pioglitazone)
  • Teva UK (glibenclamide, glimepiride, glipizide, metformin)
  • Tillomed Laboratories (metformin)
  • Winthrop Pharmaceuticals UK (glimepiride, metformin)
  • Wockhardt UK (glibenclamide, insulin, metformin)

Relevant research groups

  • Cochrane Metabolic & Endocrine Disorders Group
  • Diabetes Foundation
  • Heart Disease and Diabetes Research Trust
  • MRC Clinical Trials Unit
  • National Institute for Health Research
  • Research Institute for the Care of Older People

Evidence Review Group

  • National Institute for Health Research Health Technology Assessment Programme
  • Warwick Evidence

Associated guideline groups

  • National Clinical Guidelines Centre

Associated public health groups

  • None



Project history

Date Update
19 March 2013 Following the discussion on 5th March 2013, the Appraisal Committee decided that the Manufacturer's response to the ACD requires further independent review and assessment before it can be satisfied that it has a reliable estimate of cost effectiveness on which to base its decision. NICE has therefore asked the decision support unit to further review the economic analysis provided in response to consultation and to perform exploratory analyses, particularly in relation to how changes in weight are modelled over time for the different treatments.  The Committee will discuss dapagliflozin again at its meeting on 9th April 2013.
9 October 2012 The first Appraisal Committee discussion will now take place on 8th January 2013. The second Committee discussion if required will take place on 5th March 2013.  The allocated Evidence Review Group for this topic has changed to Health Economics Research Unit, University of Aberdeen. The NICE Decision Support Unit will assist in providing an evaluation of the manufacturer’s economic analysis.
7 September 2012 The timelines for the appraisal of dapagliflozin for type 2 diabetes have been extended. This is to allow further resource to be applied to the evaluation of the manufacturer’s economic analysis.


Key documents

This page was last updated: 02 July 2013

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