A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients
NCT ID: NCT02616666
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
632 participants
INTERVENTIONAL
2016-08-25
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dapagliflozin 10 mg
Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.
Dapagliflozin
The product in study is dapagliflozin (FORXIGA™), 10 mg film-coated tablets, and FORXIGA™ should be prescribed according to the instructions in the SmPC and current practice, including up-titration (if considered appropriate by the investigator). Dapagliflozin will be given in combination with metformin.
Standard of Care (SOC)
Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.
Standard of Care
The comparator arm consists of SOC. The SOC arm can be sulphonylurea (SU) or non-SU treatments. SU treatments will include any SU and the related insulin secretagogues repaglinide or nateglinide, each of them in combination with metformin. The non-SU treatments can be metformin and dipeptidyl peptidase 4 inhibitors (DPP-4i), or metformin and glitazones (pioglitazone) combination therapy. Other SGLT-2 inhibitors are excluded. All these treatments are approved in the UK for use in this patient population.
Interventions
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Dapagliflozin
The product in study is dapagliflozin (FORXIGA™), 10 mg film-coated tablets, and FORXIGA™ should be prescribed according to the instructions in the SmPC and current practice, including up-titration (if considered appropriate by the investigator). Dapagliflozin will be given in combination with metformin.
Standard of Care
The comparator arm consists of SOC. The SOC arm can be sulphonylurea (SU) or non-SU treatments. SU treatments will include any SU and the related insulin secretagogues repaglinide or nateglinide, each of them in combination with metformin. The non-SU treatments can be metformin and dipeptidyl peptidase 4 inhibitors (DPP-4i), or metformin and glitazones (pioglitazone) combination therapy. Other SGLT-2 inhibitors are excluded. All these treatments are approved in the UK for use in this patient population.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Provision of informed consent prior to any study specific procedures
2. Females and males aged ≥18 years up to ≤ 75 years
3. Diagnosed with Type 2 Diabetes Mellitus.
4. Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c \> 6.5%.
5. Ability to read and write as judged by the investigator.
Exclusion Criteria
2. Previous enrolment or randomization in the present study
3. Age \> 75 years
4. Pregnancy/active breast feeding at the time of inclusion
5. Known moderate to severe renal impairment (eGFR\<60ml/min).
6. Participation in an interventional clinical trial ≤ 3 months before enrolment.
7. Unsuitable to participate on mental health grounds, as judged by the investigator.
8. Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.
9. Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Clinical Practice Research Datalink
OTHER_GOV
University of Liverpool
OTHER
Responsible Party
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Principal Investigators
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John Wilding, MBChB, DM
Role: PRINCIPAL_INVESTIGATOR
Universtiy of Liverpool, University Hospital, Aintree, Longmoor Lane, Liverpool, L9 7AL, UK
Jesús Medina, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Susan Beatty, MSc
Role: STUDY_DIRECTOR
Clinical Practice Research Datalink
Locations
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Research Site
Forfar, Angus, United Kingdom
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Yate, Avon, United Kingdom
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Bracknell, Berkshire, United Kingdom
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Reading, Berkshire, United Kingdom
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Wokingham, Berkshire, United Kingdom
Research Site, Alum Rock
Birmingham, Birmingham, United Kingdom
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Maesteg, Bridgend, United Kingdom
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Chew Stoke, Bristol, United Kingdom
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Yate, Bristol, United Kingdom
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Iver, Bucks, United Kingdom
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Blackwood, Caerphilly, United Kingdom
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Hengoed, Caerphilly, United Kingdom
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Greenisland, Carrickfergus, United Kingdom
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Whitehead, Carrickfergus, United Kingdom
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Macclesfield, Cheshire, United Kingdom
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Crook, County Durham, United Kingdom
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Denbigh, Denbighshire, United Kingdom
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Exeter, Devon, United Kingdom
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Hull, East Yorkshire, United Kingdom
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Romford, Essex, United Kingdom
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Pinhoe, Exeter, United Kingdom
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Cheltenham, Gloucestershire, United Kingdom
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Trafford, Greater Manchester, United Kingdom
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Worsley, Greater Manchester, United Kingdom
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Alton, Hampshire, United Kingdom
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Farnborough, Hampshire, United Kingdom
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Gosport, Hampshire, United Kingdom
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Havant, Hampshire, United Kingdom
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Romsey, Hampshire, United Kingdom
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Southampton, Hampshire, United Kingdom
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Waterlooville, Hampshire, United Kingdom
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Winchester, Hampshire, United Kingdom
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Southampton, Hants, United Kingdom
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Leominster, Herefordshire, United Kingdom
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Fortrose, Highland, United Kingdom
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Beckenham, Kent, United Kingdom
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Canterbury, Kent, United Kingdom
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Faversham, Kent, United Kingdom
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Gravesend, Kent, United Kingdom
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Rainham, Kent, United Kingdom
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Kineton, Kineton, United Kingdom
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Barnoldswick, Lancashire, United Kingdom
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Blackburn, Lancashire, United Kingdom
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Darwen, Lancashire, United Kingdom
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Lancaster, Lancashire, United Kingdom
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Nelson, Lancashire, United Kingdom
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Thornton-Cleveleys, Lancashire, United Kingdom
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Thornton-Cleveleys, Lancs, United Kingdom
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Loughborough, Leicestershire, United Kingdom
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Balham, London, United Kingdom
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Brockley, London, United Kingdom
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London, London, United Kingdom
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Rotherhithe, London, United Kingdom
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Streatham, London, United Kingdom
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Trafford, Manchester, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
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Wembley, Middlesex, United Kingdom
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Glyncorrwg, Neath Port Talbot, United Kingdom
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Newport, Newport, United Kingdom
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Swaffham, Norfolk, United Kingdom
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Clevedon, North Somerset, United Kingdom
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Pickering, North Yorkshire, United Kingdom
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Ripon, North Yorkshire, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Nottingham, Notts, United Kingdom
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Bicester, Oxfordshire, United Kingdom
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Carterton, Oxfordshire, United Kingdom
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Oxford, Oxfordshire, United Kingdom
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Wantage, Oxfordshire, United Kingdom
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Witney, Oxfordshire, United Kingdom
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Oxford, Oxford, United Kingdom
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Oxford, Oxon, United Kingdom
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Milford Haven, Pembrokeshire, United Kingdom
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Tonypandy, Rhondda Cynon Taff, United Kingdom
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Pontypridd, Rhondda Cynon Taf, United Kingdom
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Telford, Shropshire, United Kingdom
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Axbridge, Somerset, United Kingdom
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Ayr, South Ayrshire, United Kingdom
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Conisbrough, South Yorkshire, United Kingdom
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Worsborough, South Yorkshire, United Kingdom
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Bury St Edmunds, Suffolk, United Kingdom
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Camberley, Surrey, United Kingdom
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Guildford, Surrey, United Kingdom
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London, Surrey, United Kingdom
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Killay, Swansea, United Kingdom
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Barry, Vale of Glamorgan, United Kingdom
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Nuneaton, Warks, United Kingdom
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Alcester, Warwickshire, United Kingdom
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Atherstone, Warwickshire, United Kingdom
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Bidford-on-Avon, Warwickshire, United Kingdom
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Nuneaton, Warwickshire, United Kingdom
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Stratford-upon-Avon, Warwickshire, United Kingdom
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Warwick, Warwickshire, United Kingdom
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Walsall, West Midlands, United Kingdom
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Wolverhampton, West Midlands, United Kingdom
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Crawley, West Sussex, United Kingdom
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Swindon, Wiltshire, United Kingdom
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Droitwich, Worcestershire, United Kingdom
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Kidderminster, Worcestershire, United Kingdom
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Malvern, Worcestershire, United Kingdom
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Alton, , United Kingdom
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Altrincham, , United Kingdom
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Blackburn, , United Kingdom
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Cambridge, , United Kingdom
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Cirencester, , United Kingdom
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Cockermouth, , United Kingdom
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Colchester, , United Kingdom
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Colindale, , United Kingdom
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Dudley, , United Kingdom
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Edmonton, , United Kingdom
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Fareham, , United Kingdom
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Fleet, , United Kingdom
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Gravesend, , United Kingdom
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Hull, , United Kingdom
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Kings Norton, , United Kingdom
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Langport, , United Kingdom
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Liphook, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Maryport, , United Kingdom
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Morriston, , United Kingdom
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Oxford, , United Kingdom
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Petersfield, , United Kingdom
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Rowlands Castle, , United Kingdom
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Royal Leamington Spa, , United Kingdom
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Stansted, , United Kingdom
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Stratford-upon-Avon, , United Kingdom
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Torquay, , United Kingdom
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Wallsend, , United Kingdom
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Waterlooville, , United Kingdom
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Wembley, , United Kingdom
Countries
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Other Identifiers
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2015-001873-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1690R00009
Identifier Type: -
Identifier Source: org_study_id