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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

632

Participants

Timeline

Start Date

August 25, 2016

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

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.

DRUG

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.

Trial Locations (132)

Unknown

Research Site, Forfar

Research Site, Yate

Research Site, Bracknell

Research Site, Reading

Research Site, Wokingham

Research Site, Alum Rock, Birmingham

Research Site, Maesteg

Research Site, Chew Stoke

Research Site, Yate

Research Site, Iver

Research Site, Blackwood

Research Site, Hengoed

Research Site, Greenisland

Research Site, Whitehead

Research Site, Macclesfield

Research Site, Crook

Research Site, Denbigh

Research Site, Exeter

Research Site, Hull

Research Site, Romford

Research Site, Pinhoe

Research Site, Cheltenham

Research Site, Trafford

Research Site, Worsley

Research Site, Alton

Research Site, Farnborough

Research Site, Gosport

Research Site, Havant

Research Site, Romsey

Research Site, Southampton

Research Site, Waterlooville

Research Site, Winchester

Research Site, Southampton

Research Site, Leominster

Research Site, Fortrose

Research Site, Beckenham

Research Site, Canterbury

Research Site, Faversham

Research Site, Gravesend

Research Site, Rainham

Research Site, Market Square, Kineton

Research Site, Barnoldswick

Research Site, Blackburn

Research Site, Darwen

Research Site, Lancaster

Research Site, Nelson

Research Site, Thornton-Cleveleys

Research Site, Thornton-Cleveleys

Research Site, Loughborough

Research Site, Balham

Research Site, Brockley

Research Site, London

Research Site, Rotherhithe

Research Site, Streatham

Research Site, Trafford

Research Site, Liverpool

Research Site, Metropolitan Borough of Wirral

Research Site, Wembley

Research Site, Glyncorrwg

Research Site, Newport

Research Site, Swaffham

Research Site, Clevedon

Research Site, Pickering

Research Site, Ripon

Research Site, Nottingham

Research Site, Nottingham

Research Site, Bicester

Research Site, Carterton

Research Site, Oxford

Research Site, Wantage

Research Site, Witney

Research Site, Oxford

Research Site, Oxford

Research Site, Milford Haven

Research Site, Tonypandy

Research Site, Pontypridd

Research Site, Telford

Research Site, Axbridge

Research Site, Ayr

Research Site, Conisbrough

Research Site, Worsborough

Research Site, Bury St Edmunds

Research Site, Camberley

Research Site, Guildford

Research Site, London

Research Site, Killay

Research Site, Barry

Research Site, Nuneaton

Research Site, Alcester

Research Site, Atherstone

Research Site, Bidford-on-Avon

Research Site, Nuneaton

Research Site, Stratford-upon-Avon

Research Site, Warwick

Research Site, Walsall

Research Site, Wolverhampton

Research Site, Crawley

Research Site, Swindon

Research Site, Droitwich

Research Site, Kidderminster

Research Site, Malvern

Research Site, Alton

Research Site, Altrincham

Research Site, Blackburn

Research Site, Cambridge

Research Site, Cirencester

Research Site, Cockermouth

Research Site, Colchester

Research Site, Colindale

Research Site, Dudley

Research Site, Edmonton

Research Site, Fareham

Research Site, Fleet

Research Site, Gravesend

Research Site, Hull

Research Site, Kings Norton

Research Site, Langport

Research Site, Liphook

Research Site, Liverpool

Research Site, Maryport

Research Site, Morriston

Research Site, Petersfield

Research Site, Rowlands Castle

Research Site, Royal Leamington Spa

Research Site, Stansted

Research Site, Stratford-upon-Avon

Research Site, Torquay

Research Site, Wallsend

Research Site, Waterlooville

Research Site, Wembley

N8

Research Site, London

OX2

Research Site, Oxford

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Clinical Practice Research Datalink

OTHER_GOV

lead

University of Liverpool

OTHER