Type 2 Diabetes MellitusPhase 4DECIDENCT02616666

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

A Phase 4 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by University of Liverpool at 132 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 632 participants
Where: 132 sitesUnited Kingdom
Study dates: 25 Aug 2016to 12 Dec 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For inclusion in the study patients should fulfil the following criteria at the time of screening:
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.

Who cannot join

Patients should not enter the study if any of the following exclusion criteria are fulfilled:
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
Pregnancy/active breast feeding at the time of inclusion
Known moderate to severe renal impairment (eGFR<60ml/min).

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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.

Trial locations and contacts

132 sites in 1 country.

City, postcode or hospital

132 sites in 1 country

United Kingdom132 sites

Research Site
Alcester, Warwickshire
Research Site
Alton, Hampshire
Research Site
Alton
Research Site
Altrincham
Research Site
Atherstone, Warwickshire
Research Site
Axbridge, Somerset
Research Site
Ayr, South Ayrshire
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Balham, London
Research Site
Barnoldswick, Lancashire
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Barry, Vale of Glamorgan
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Beckenham, Kent
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Bicester, Oxfordshire
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Bidford-on-Avon, Warwickshire
Research Site, Alum Rock
Birmingham, Birmingham
Research Site
Blackburn, Lancashire
Research Site
Blackburn
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Blackwood, Caerphilly
Research Site
Bracknell, Berkshire
Research Site
Brockley, London
Research Site
Bury St Edmunds, Suffolk
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Camberley, Surrey
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Cambridge
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Canterbury, Kent
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Carterton, Oxfordshire
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Cheltenham, Gloucestershire
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Chew Stoke, Bristol
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Cirencester
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Clevedon, North Somerset
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Cockermouth
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Colchester
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Colindale
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Conisbrough, South Yorkshire
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Crawley, West Sussex
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Crook, County Durham
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Darwen, Lancashire
Research Site
Denbigh, Denbighshire
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Droitwich, Worcestershire
Research Site
Dudley
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Edmonton
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Exeter, Devon
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Fareham
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Farnborough, Hampshire
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Faversham, Kent
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Fleet
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Forfar, Angus
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Fortrose, Highland
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Glyncorrwg, Neath Port Talbot
Research Site
Gosport, Hampshire
Research Site
Gravesend, Kent
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Gravesend
Research Site
Greenisland, Carrickfergus
Research Site
Guildford, Surrey
Research Site
Havant, Hampshire
Research Site
Hengoed, Caerphilly
Research Site
Hull, East Yorkshire
Research Site
Hull
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Iver, Bucks
Research Site
Kidderminster, Worcestershire
Research Site
Killay, Swansea
Research Site, Market Square
Kineton, Kineton
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Kings Norton
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Lancaster, Lancashire
Research Site
Langport
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Leominster, Herefordshire
Research Site
Liphook
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Liverpool, Merseyside
Research Site
Liverpool
Research Site
London, London
Research Site
London, Surrey
Research Site
London, N8
Research Site
Loughborough, Leicestershire
Research Site
Macclesfield, Cheshire
Research Site
Maesteg, Bridgend
Research Site
Malvern, Worcestershire
Research Site
Maryport
Research Site
Metropolitan Borough of Wirral, Merseyside
Research Site
Milford Haven, Pembrokeshire
Research Site
Morriston
Research Site
Nelson, Lancashire
Research Site
Newport, Newport
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Nottingham, Nottinghamshire
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Nottingham, Notts
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Nuneaton, Warks
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Nuneaton, Warwickshire
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Oxford, Oxfordshire
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Oxford, Oxford
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Oxford, Oxon
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Oxford, OX2
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Petersfield
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Pickering, North Yorkshire
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Pinhoe, Exeter
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Pontypridd, Rhondda Cynon Taf
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Rainham, Kent
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Reading, Berkshire
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Ripon, North Yorkshire
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Romford, Essex
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Romsey, Hampshire
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Rotherhithe, London
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Rowlands Castle
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Royal Leamington Spa
Research Site
Southampton, Hampshire
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Southampton, Hants
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Stansted
Research Site
Stratford-upon-Avon, Warwickshire
Research Site
Stratford-upon-Avon
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Streatham, London
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Swaffham, Norfolk
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Swindon, Wiltshire
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Telford, Shropshire
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Thornton-Cleveleys, Lancashire
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Thornton-Cleveleys, Lancs
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Tonypandy, Rhondda Cynon Taff
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Torquay
Research Site
Trafford, Greater Manchester
Research Site
Trafford, Manchester
Research Site
Wallsend
Research Site
Walsall, West Midlands
Research Site
Wantage, Oxfordshire
Research Site
Warwick, Warwickshire
Research Site
Waterlooville, Hampshire
Research Site
Waterlooville
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Wembley, Middlesex
Research Site
Wembley
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Whitehead, Carrickfergus
Research Site
Winchester, Hampshire
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Witney, Oxfordshire
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Wokingham, Berkshire
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Wolverhampton, West Midlands
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Worsborough, South Yorkshire
Research Site
Worsley, Greater Manchester
Research Site
Yate, Avon
Research Site
Yate, Bristol

Other trials in United Kingdom

About this study

Official title: A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)

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

Read the detailed description

A longitudinal, open labelled, pragmatic randomized 104 week multicentre 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
Being tested: Dapagliflozin, Standard of Care
Keywords: Type 2 diabetes mellitus, Randomised, Pragmatic, Standard of Care, Dapagliflozin, FORXIGA
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
Also called FORXIGA
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 CareDrug
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.

Study groups in NCT02616666
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
HbA1c reduction
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: up to 52 weeks following randomization and separately, up to 104 weeks following randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 201612 Dec 2025

First posted30 Nov 2015 (estimated)
Study start25 Aug 2016
Primary completion12 Dec 2025
Study completion12 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 632 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02616666
Sponsor's protocol ID: D1690R00009
Other IDs: 2015-001873-42, 2015
Acronym: DECIDE
Status last verified: Feb 2026
First submitted: 17 Nov 2015
Last updated: 20 Feb 2026
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)
ClinicalTrials.gov ID: NCT02616666
Acronym / sponsor ID: DECIDE / D1690R00009
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus, Randomised, Pragmatic, Standard of Care, Dapagliflozin, FORXIGA
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 632 participants (actual)
Lead sponsor: University of LiverpoolUniversity, hospital or other
Collaborators: AstraZeneca, Clinical Practice Research Datalink
Study start: 25 Aug 2016 (actual)
Primary completion: 12 Dec 2025 (actual)
Study completion: 12 Dec 2025 (actual)
First posted: 30 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin 10 mg	Experimental	Drug: DapagliflozinPatients 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 (SOC)	Active comparator	Drug: Standard of CarePatients 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

For inclusion in the study patients should fulfil the following criteria at the time of screening:
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%.

Key exclusion criteria (10 listed)

Patients should not enter the study if any of the following exclusion criteria are fulfilled:
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
Pregnancy/active breast feeding at the time of inclusion

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinAlso: FORXIGAThe 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.	Drug	Dapagliflozin 10 mg
Standard of CareThe 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.	Drug	Standard of Care (SOC)

Primary outcome

Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.
Time frame: 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).
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).

13 secondary outcomes

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).
Time frame: 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).
Time frame: 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).
Time frame: 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 (
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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),
Time frame: 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:
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: up to 52 weeks following randomization and separately, up to 104 weeks following randomization.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Wilding, MBChB, DM principal investigator

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

Jesús Medina, PhD study director

AstraZeneca

Susan Beatty, MSc study director

Clinical Practice Research Datalink

132 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by University of Liverpool at 132 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving clinical success as measured by a 4-item composite endpoint. (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.