A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients

NCT02616666 | Completed Phase 4

• 2 other identifiers: D1690R000092015-001873-42
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 132

Brief Summary

A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Randomised; Pragmatic; Standard of Care; Dapagliflozin; FORXIGA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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).

  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).

  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).

  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 (

  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, closet to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).

Study Arms (2)

Dapagliflozin 10 mg

EXPERIMENTAL

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.

Drug: Dapagliflozin

Standard of Care (SOC)

ACTIVE COMPARATOR

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.

Drug: Standard of Care

Interventions

Dapagliflozin DRUG

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.

Also known as: FORXIGA

Dapagliflozin 10 mg

Standard of Care DRUG

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.

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Females and males aged ≥18 years up to ≤ 75 years
• Diagnosed with Type 2 Diabetes Mellitus.
• Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c \> 6.5%.
• Ability to read and write as judged by the investigator.

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Previous enrolment or randomization in the present study
• Age \> 75 years
• Known moderate to severe renal impairment (eGFR\<60ml/min).
• Participation in an interventional clinical trial ≤ 3 months before enrolment.
• Unsuitable to participate on mental health grounds, as judged by the investigator.
• Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.
• Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.

Sponsors & Collaborators

• University of Liverpool: lead
• AstraZeneca: collaborator
• Clinical Practice Research Datalink: collaborator

Study Sites (132)

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

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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, N8, United Kingdom

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Maryport, United Kingdom

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Morriston, United Kingdom

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Oxford, OX2, 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

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• John Wilding, MBChB, DM

  Universtiy of Liverpool, University Hospital, Aintree, Longmoor Lane, Liverpool, L9 7AL, UK

  PRINCIPAL INVESTIGATOR

• Jesús Medina, PhD

  AstraZeneca

  STUDY DIRECTOR

• Susan Beatty, MSc

  Clinical Practice Research Datalink

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 30, 2015
• Study Start: August 25, 2016
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

GB (132)