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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Standard of Care

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)

• Study Type: Interventional
• Enrollment (Actual): 632
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Alton, United Kingdom
    • Research Site
  • Altrincham, United Kingdom
    • Research Site
  • Birmingham, United Kingdom
    • Research Site, Alum Rock
  • 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
  • Kineton, United Kingdom
    • Research Site, Market Square
  • 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, United Kingdom
    • Research Site
  • London, United Kingdom, N8
    • Research Site
  • Maryport, United Kingdom
    • Research Site
  • Morriston, United Kingdom
    • Research Site
  • Newport, United Kingdom
    • Research Site
  • Oxford, United Kingdom
    • Research Site
  • Oxford, United Kingdom, OX2
    • 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
    • Research Site
  • Angus
    • Forfar, Angus, United Kingdom
      • Research Site
  • Avon
    • Yate, Avon, United Kingdom
      • Research Site
  • Berkshire
    • Bracknell, Berkshire, United Kingdom
      • Research Site
    • Reading, Berkshire, United Kingdom
      • Research Site
    • Wokingham, Berkshire, United Kingdom
      • Research Site
  • Bridgend
    • Maesteg, Bridgend, United Kingdom
      • Research Site
  • Bristol
    • Chew Stoke, Bristol, United Kingdom
      • Research Site
    • Yate, Bristol, United Kingdom
      • Research Site
  • Bucks
    • Iver, Bucks, United Kingdom
      • Research Site
  • Caerphilly
    • Blackwood, Caerphilly, United Kingdom
      • Research Site
  • Carrickfergus
    • Greenisland, Carrickfergus, United Kingdom
      • Research Site
    • Whitehead, Carrickfergus, United Kingdom
      • Research Site
  • Cheshire
    • Macclesfield, Cheshire, United Kingdom
      • Research Site
  • County Durham
    • Crook, County Durham, United Kingdom
      • Research Site
  • Denbighshire
    • Denbigh, Denbighshire, United Kingdom
      • Research Site
  • Devon
    • Exeter, Devon, United Kingdom
      • Research Site
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom
      • Research Site
  • Essex
    • Romford, Essex, United Kingdom
      • Research Site
  • Exeter
    • Pinhoe, Exeter, United Kingdom
      • Research Site
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom
      • Research Site
  • Greater Manchester
    • Trafford, Greater Manchester, United Kingdom
      • Research Site
    • Worsley, Greater Manchester, United Kingdom
      • Research Site
  • Hampshire
    • 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
  • Hants
    • Southampton, Hants, United Kingdom
      • Research Site
  • Herefordshire
    • Leominster, Herefordshire, United Kingdom
      • Research Site
  • Highland
    • Fortrose, Highland, United Kingdom
      • Research Site
  • Kent
    • 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
  • Lancashire
    • 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
  • Lancs
    • Thornton-Cleveleys, Lancs, United Kingdom
      • Research Site
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom
      • Research Site
  • London
    • Brockley, London, United Kingdom
      • Research Site
    • Rotherhithe, London, United Kingdom
      • Research Site
    • Streatham, London, United Kingdom
      • Research Site
  • Manchester
    • Trafford, Manchester, United Kingdom
      • Research Site
  • Merseyside
    • Liverpool, Merseyside, United Kingdom
      • Research Site
    • Wirral, Merseyside, United Kingdom
      • Research Site
  • Middlesex
    • Wembley, Middlesex, United Kingdom
      • Research Site
  • Neath Port Talbot
    • Glyncorrwg, Neath Port Talbot, United Kingdom
      • Research Site
  • Norfolk
    • Swaffham, Norfolk, United Kingdom
      • Research Site
  • North Somerset
    • Clevedon, North Somerset, United Kingdom
      • Research Site
  • North Yorkshire
    • Pickering, North Yorkshire, United Kingdom
      • Research Site
    • Ripon, North Yorkshire, United Kingdom
      • Research Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom
      • Research Site
  • Notts
    • Nottingham, Notts, United Kingdom
      • Research Site
  • Oxfordshire
    • 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
  • Oxon
    • Oxford, Oxon, United Kingdom
      • Research Site
  • Pembrokeshire
    • Milford Haven, Pembrokeshire, United Kingdom
      • Research Site
  • Rhondda Cynon Taf
    • Pontypridd, Rhondda Cynon Taf, United Kingdom
      • Research Site
  • Rhondda Cynon Taff
    • Tonypandy, Rhondda Cynon Taff, United Kingdom
      • Research Site
  • Shropshire
    • Telford, Shropshire, United Kingdom
      • Research Site
  • Somerset
    • Axbridge, Somerset, United Kingdom
      • Research Site
  • South Ayrshire
    • Ayr, South Ayrshire, United Kingdom
      • Research Site
  • South Yorkshire
    • Worsborough, South Yorkshire, United Kingdom
      • Research Site
  • Suffolk
    • Bury St Edmunds, Suffolk, United Kingdom
      • Research Site
  • Surrey
    • Camberley, Surrey, United Kingdom
      • Research Site
    • Guildford, Surrey, United Kingdom
      • Research Site
    • London, Surrey, United Kingdom
      • Research Site
  • Swansea
    • Killay, Swansea, United Kingdom
      • Research Site
  • Vale Of Glamorgan
    • Barry, Vale Of Glamorgan, United Kingdom
      • Research Site
  • Warks
    • Nuneaton, Warks, United Kingdom
      • Research Site
  • Warwickshire
    • 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
  • West Midlands
    • Walsall, West Midlands, United Kingdom
      • Research Site
    • Wolverhampton, West Midlands, United Kingdom
      • Research Site
  • West Sussex
    • Crawley, West Sussex, United Kingdom
      • Research Site
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom
      • Research Site
  • Worcestershire
    • Droitwich, Worcestershire, United Kingdom
      • Research Site
    • Kidderminster, Worcestershire, United Kingdom
      • Research Site
    • Malvern, Worcestershire, United Kingdom
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin 10 mg; 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; 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.; Other Names: FORXIGA
Active Comparator: Standard of Care (SOC); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Heart failure; Gangrene or amputation of the leg, foot or toe; Diabetic ketoacidosis; Cerebrovascular disease; Nonfatal myocardial infarction; Blindness; 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.

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: AstraZeneca; Clinical Practice Research Datalink
• Investigators: Study Director: Jesús Medina, PhD, AstraZeneca; Principal Investigator: John Wilding, MBChB, DM, Universtiy of Liverpool, University Hospital, Aintree, Longmoor Lane, Liverpool, L9 7AL, UK; Study Director: Susan Beatty, MSc, Clinical Practice Research Datalink

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2016
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimated): November 30, 2015

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dapagliflozin; Type 2 diabetes mellitus; Standard of Care; Randomised; Pragmatic; FORXIGA
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: D1690R00009; 2015-001873-42 (EudraCT Number)