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

Type 2 Diabetes Mellitus Clinical Trial

— DECIDE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02616666
• Other study ID #: D1690R00009
• Secondary ID: 2015-001873-42
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 25, 2016
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 632
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Liverpool	AstraZeneca, Clinical Practice Research Datalink

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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)
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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).
Secondary	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.