Clinical trial NCT02616666: A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients
Official title: A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Randomised
Pragmatic
Standard of Care
Dapagliflozin
FORXIGA
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Clinical Practice Research Datalink
First posted: 2015-11-30
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.
timeFrame: 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:
measure: 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).
timeFrame: From randomization to 104 weeks of follow up.
measure: 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).
timeFrame: 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)
measure: 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).
timeFrame: Up to 52 weeks following randomization and separately, up to 104 weeks following randomization (in both cases, allowing a window of 12 weeks).
measure: 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 (
timeFrame: up to 52 weeks following randomization and separately, up to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).
measure: To assess differences between dapagliflozin and SOC in the change from baseline in HbA1
timeFrame: 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).
measure: 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
timeFrame: At 6, 12, 18 and 24 months
measure: 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
timeFrame: At 6, 12, 18 and 24 months
measure: 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
timeFrame: At 6, 12, 18 and 24 months
measure: To assess differences between dapagliflozin and SOC in the proportion of patients needing antihypertensive escalation (dose up titration, switch and add-on strategies),
timeFrame: up to 52 weeks following randomization and separately, up to 104 weeks following randomization.
measure: To assess differences between dapagliflozin and SOC in the proportion of patients with diabetic complications:
timeFrame: up to 52 weeks following randomization and separately, up to 104 weeks following randomization.
measure: To assess differences between dapagliflozin and SOC in the change from baseline in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)
timeFrame: 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)
measure: To assess differences between dapagliflozin and SOC in the change from baseline in eGFR
timeFrame: 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).
measure: 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
timeFrame: up to 52 weeks following randomization and separately, up to 104 weeks following randomization.
Other outcomes:
Locations:
city: Forfar
country: United Kingdom
facility: Research Site
state: Angus
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country: United Kingdom
facility: Research Site
state: Avon
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facility: Research Site
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facility: Research Site, Alum Rock
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facility: Research Site
city: Cambridge
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city: Fareham
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city: Fleet
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facility: Research Site
city: Gravesend
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Kineton
country: United Kingdom
facility: Research Site, Market Square
city: Kings Norton
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city: Langport
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city: Leamington Spa
country: United Kingdom
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city: Liphook
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city: Liverpool
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facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
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city: Maryport
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city: Morriston
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city: Newport
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facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Petersfield
country: United Kingdom
facility: Research Site
city: Rowlands Castle
country: United Kingdom
facility: Research Site
city: Stansted
country: United Kingdom
facility: Research Site
city: Stratford-upon-Avon
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
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city: Wallsend
country: United Kingdom
facility: Research Site
city: Waterlooville
country: United Kingdom
facility: Research Site
city: Wembley
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Universtiy of Liverpool, University Hospital, Aintree, Longmoor Lane, Liverpool, L9 7AL, UK
name: John Wilding, MBChB, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Jesús Medina, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Practice Research Datalink
name: Susan Beatty, MSc
role: STUDY_DIRECTOR
References: