New diabetes drug dapagliflozin put to the test against standard care

NCT ID NCT02616666

Disease control Sponsor: University of Liverpool Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug dapagliflozin (Forxiga) works better than standard treatments for people with type 2 diabetes whose blood sugar is not well controlled on metformin alone. Over 600 adults took either dapagliflozin plus metformin or usual care (like sulfonylureas). Researchers tracked blood sugar control, weight loss, and safety for up to two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: dapagliflozin (brand name Forxiga), a tablet taken by mouth
What this could lead to: If successful, this could show that dapagliflozin helps more people achieve better blood sugar control and weight loss without increasing hypoglycemia risk compared to usual treatments.
What could go wrong: This is a completed Phase 4 trial, so results are already known. However, it was relatively small (632 people) and may not apply to all diabetes patients. Dapagliflozin can cause side effects like urinary infections or dehydration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

632 people

The number who actually took part.

Started

Aug 2016

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For inclusion in the study patients should fulfil the following criteria at the time of screening: 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: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

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

London, 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

Metropolitan Borough of Wirral, Merseyside, United Kingdom
Research Site

Wembley, Middlesex, United Kingdom
Research Site

Glyncorrwg, Neath Port Talbot, United Kingdom
Research Site

Newport, Newport, 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, Oxford, 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

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

Kings Norton, United Kingdom
Research Site

Langport, United Kingdom
Research Site

Liphook, United Kingdom
Research Site

Liverpool, United Kingdom
Research Site

London, N8, United Kingdom
Research Site

Maryport, United Kingdom
Research Site

Morriston, United Kingdom
Research Site

Oxford, OX2, United Kingdom
Research Site

Petersfield, United Kingdom
Research Site

Rowlands Castle, United Kingdom
Research Site

Royal Leamington Spa, 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
Research Site, Alum Rock

Birmingham, Birmingham, United Kingdom
Research Site, Market Square

Kineton, Kineton, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.