| Outcome Measures: |
Primary: Proportion of patients achieving clinical success as measured by a 4-item composite endpoint., Proportion of patients achieving clinical success as measured by a 4-item composite endpoint including HbA1c reduction vs. baseline (≥ 0.5%), weight loss vs. baseline (≥ 2 Kg), no reported severe or documented hypoglycaemic events since randomization, and no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC),at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks)., Assessment of outcome measure will be made at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks). | Secondary: HbA1c success (HbA1c reduction vs. baseline ≥ 0.5%) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)., HbA1c reduction, From randomization to 104 weeks of follow up.|Weight loss success (weight vs. baseline ≥ 2 Kg) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)., Weight Loss success, closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)|Severe or documented hypoglycaemic events up to 52 weeks following randomization and separately, up to 104 weeks following randomization (in both cases, allowing a window of 12 weeks)., Documented Hypoglycaemic events, Up to 52 weeks following randomization and separately, up to 104 weeks following randomization (in both cases, allowing a window of 12 weeks).|To assess differences between dapagliflozin and SOC in the proportion of patients not switching from or adding to the treatment to which the patient was randomized (, Switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC) up to 52 weeks following randomization and separately, up to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)., up to 52 weeks following randomization and separately, up to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).|To assess differences between dapagliflozin and SOC in the change from baseline in HbA1, HbA1c at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)., HbA1c at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closet to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).|To assess differences between dapagliflozin and SOC in the patients worry related to the risk of hypoglycaemic episodes measured b HFS-II Worry Scale at 6,12, 18 and 24 months, To assess differences between dapagliflozin and SOC in the patients worry related to the risk of hypoglycaemic episodes measured b HFS-II Worry Scale at 6,12, 18 and 24 months, At 6, 12, 18 and 24 months|To assess differences between dapagliflozin and SOC in the patients satisfaction with treatment as measured by the DTSQ at 6, 12, 18 and 24 months, To assess differences between dapagliflozin and SOC in the patients satisfaction with treatment as measured by the DTSQ at 6, 12, 18 and 24 months, At 6, 12, 18 and 24 months|To assess differences between dapagliflozin and SOC in the patients health related quality of life as measured by SF35v2 at 6, 12, 18 and 24 months, To assess differences between dapagliflozin and SOC in the patients health related quality of life, specifically physical, functioning, role functioning and vitality domains as measured by SF35v2 at 6, 12, 18 and 24 months, At 6, 12, 18 and 24 months|To assess differences between dapagliflozin and SOC in the proportion of patients needing antihypertensive escalation (dose up titration, switch and add-on strategies),, Antihypertensive initiation or escalation (dose up titration, switch and add-on strategies), up to 52 weeks following randomization and separately, up to 104 weeks following randomization., up to 52 weeks following randomization and separately, up to 104 weeks following randomization.|To assess differences between dapagliflozin and SOC in the proportion of patients with diabetic complications:, Proportion of patients with the following diabetic complications: 1. Heart failure 2. Gangrene or amputation of the leg, foot or toe 3. Diabetic ketoacidosis 4. Cerebrovascular disease 5. Nonfatal myocardial infarction 6. Blindness 7. Neuropathy, up to 52 weeks following randomization and separately, up to 104 weeks following randomization.|To assess differences between dapagliflozin and SOC in the change from baseline in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg), To assess differences between dapagliflozin and SOC in the change from baseline in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)., Closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)|To assess differences between dapagliflozin and SOC in the change from baseline in eGFR, eGFR (ml/min) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks)., closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).|To assess differences between dapagliflozin and SOC in the healthcare resource utilization up to 52 weeks following randomization and separately, up to 104 weeks following randomization, Hospitalizations, contacts due to hypoglycaemic events, needing insulin treatment, complications and unscheduled GP visits, up to 52 weeks following randomization and separately, up to 104 weeks following randomization, up to 52 weeks following randomization and separately, up to 104 weeks following randomization.
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| Locations: |
Research Site, Forfar, Angus, United Kingdom|Research Site, Yate, Avon, United Kingdom|Research Site, Bracknell, Berkshire, United Kingdom|Research Site, Reading, Berkshire, United Kingdom|Research Site, Wokingham, Berkshire, United Kingdom|Research Site, Maesteg, Bridgend, United Kingdom|Research Site, Chew Stoke, Bristol, United Kingdom|Research Site, Yate, Bristol, United Kingdom|Research Site, Iver, Bucks, United Kingdom|Research Site, Blackwood, Caerphilly, United Kingdom|Research Site, Hengoed, Caerphilly, United Kingdom|Research Site, Greenisland, Carrickfergus, United Kingdom|Research Site, Whitehead, Carrickfergus, United Kingdom|Research Site, Macclesfield, Cheshire, United Kingdom|Research Site, Crook, County Durham, United Kingdom|Research Site, Denbigh, Denbighshire, United Kingdom|Research Site, Exeter, Devon, United Kingdom|Research Site, Hull, East Yorkshire, United Kingdom|Research Site, Romford, Essex, United Kingdom|Research Site, Pinhoe, Exeter, United Kingdom|Research Site, Cheltenham, Gloucestershire, United Kingdom|Research Site, Trafford, Greater Manchester, United Kingdom|Research Site, Worsley, Greater Manchester, United Kingdom|Research Site, Alton, Hampshire, United Kingdom|Research Site, Farnborough, Hampshire, United Kingdom|Research Site, Gosport, Hampshire, United Kingdom|Research Site, Havant, Hampshire, United Kingdom|Research Site, Romsey, Hampshire, United Kingdom|Research Site, Southampton, Hampshire, United Kingdom|Research Site, Waterlooville, Hampshire, United Kingdom|Research Site, Winchester, Hampshire, United Kingdom|Research Site, Southampton, Hants, United Kingdom|Research Site, Leominster, Herefordshire, United Kingdom|Research Site, Fortrose, Highland, United Kingdom|Research Site, Beckenham, Kent, United Kingdom|Research Site, Canterbury, Kent, United Kingdom|Research Site, Faversham, Kent, United Kingdom|Research Site, Gravesend, Kent, United Kingdom|Research Site, Rainham, Kent, United Kingdom|Research Site, Barnoldswick, Lancashire, United Kingdom|Research Site, Blackburn, Lancashire, United Kingdom|Research Site, Darwen, Lancashire, United Kingdom|Research Site, Lancaster, Lancashire, United Kingdom|Research Site, Nelson, Lancashire, United Kingdom|Research Site, Thornton-Cleveleys, Lancashire, United Kingdom|Research Site, Thornton-Cleveleys, Lancs, United Kingdom|Research Site, Loughborough, Leicestershire, United Kingdom|Research Site, Balham, London, United Kingdom|Research Site, Brockley, London, United Kingdom|Research Site, Rotherhithe, London, United Kingdom|Research Site, Streatham, London, United Kingdom|Research Site, Trafford, Manchester, United Kingdom|Research Site, Liverpool, Merseyside, United Kingdom|Research Site, Wirral, Merseyside, United Kingdom|Research Site, Wembley, Middlesex, United Kingdom|Research Site, Glyncorrwg, Neath Port Talbot, United Kingdom|Research Site, Swaffham, Norfolk, United Kingdom|Research Site, Clevedon, North Somerset, United Kingdom|Research Site, Pickering, North Yorkshire, United Kingdom|Research Site, Ripon, North Yorkshire, United Kingdom|Research Site, Nottingham, Nottinghamshire, United Kingdom|Research Site, Nottingham, Notts, United Kingdom|Research Site, Bicester, Oxfordshire, United Kingdom|Research Site, Carterton, Oxfordshire, United Kingdom|Research Site, Oxford, Oxfordshire, United Kingdom|Research Site, Wantage, Oxfordshire, United Kingdom|Research Site, Witney, Oxfordshire, United Kingdom|Research Site, Oxford, Oxon, United Kingdom|Research Site, Milford Haven, Pembrokeshire, United Kingdom|Research Site, Tonypandy, Rhondda Cynon Taff, United Kingdom|Research Site, Pontypridd, Rhondda Cynon Taf, United Kingdom|Research Site, Telford, Shropshire, United Kingdom|Research Site, Axbridge, Somerset, United Kingdom|Research Site, Ayr, South Ayrshire, United Kingdom|Research Site, Conisbrough, South Yorkshire, United Kingdom|Research Site, Worsborough, South Yorkshire, United Kingdom|Research Site, Bury St Edmunds, Suffolk, United Kingdom|Research Site, Camberley, Surrey, United Kingdom|Research Site, Guildford, Surrey, United Kingdom|Research Site, London, Surrey, United Kingdom|Research Site, Killay, Swansea, United Kingdom|Research Site, Barry, Vale of Glamorgan, United Kingdom|Research Site, Nuneaton, Warks, United Kingdom|Research Site, Alcester, Warwickshire, United Kingdom|Research Site, Atherstone, Warwickshire, United Kingdom|Research Site, Bidford-on-Avon, Warwickshire, United Kingdom|Research Site, Nuneaton, Warwickshire, United Kingdom|Research Site, Stratford-upon-Avon, Warwickshire, United Kingdom|Research Site, Warwick, Warwickshire, United Kingdom|Research Site, Walsall, West Midlands, United Kingdom|Research Site, Wolverhampton, West Midlands, United Kingdom|Research Site, Crawley, West Sussex, United Kingdom|Research Site, Swindon, Wiltshire, United Kingdom|Research Site, Droitwich, Worcestershire, United Kingdom|Research Site, Kidderminster, Worcestershire, United Kingdom|Research Site, Malvern, Worcestershire, United Kingdom|Research Site, Alton, United Kingdom|Research Site, Altrincham, United Kingdom|Research Site, Alum Rock, Birmingham, United Kingdom|Research Site, Blackburn, United Kingdom|Research Site, Cambridge, United Kingdom|Research Site, Cirencester, United Kingdom|Research Site, Cockermouth, United Kingdom|Research Site, Colchester, United Kingdom|Research Site, Colindale, United Kingdom|Research Site, Dudley, United Kingdom|Research Site, Edmonton, United Kingdom|Research Site, Fareham, United Kingdom|Research Site, Fleet, United Kingdom|Research Site, Gravesend, United Kingdom|Research Site, Hull, United Kingdom|Research Site, Market Square, Kineton, United Kingdom|Research Site, Kings Norton, United Kingdom|Research Site, Langport, United Kingdom|Research Site, Leamington Spa, United Kingdom|Research Site, Liphook, United Kingdom|Research Site, Liverpool, United Kingdom|Research Site, London, N8, United Kingdom|Research Site, London, United Kingdom|Research Site, Maryport, United Kingdom|Research Site, Morriston, United Kingdom|Research Site, Newport, United Kingdom|Research Site, Oxford, OX2, United Kingdom|Research Site, Oxford, United Kingdom|Research Site, Petersfield, United Kingdom|Research Site, Rowlands Castle, United Kingdom|Research Site, Stansted, United Kingdom|Research Site, Stratford-upon-Avon, United Kingdom|Research Site, Torquay, United Kingdom|Research Site, Wallsend, United Kingdom|Research Site, Waterlooville, United Kingdom|Research Site, Wembley, United Kingdom
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