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

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ClinicalTrials.gov Identifier: NCT02616666
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
University of Liverpool
AstraZeneca
Information provided by (Responsible Party):
Clinical Practice Research Datalink

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Dapagliflozin Drug: Standard of Care Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)
Actual Study Start Date : August 25, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Proportion of patients achieving clinical success as measured by a 4-item composite endpoint. [ Time Frame: 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). ]
    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).


Secondary Outcome Measures :
  1. Proportion of patients meeting the 4-item composite endpoint at any clinical evaluation that occurs within the first 52 weeks of follow-up [ Time Frame: Any assessment from Week 12 to Week 52 ]
  2. Proportion of patients meeting the 4-item composite endpoint at the clinical evaluation that occurs closest to 104 weeks of follow-up (allowing a window of 12 weeks) [ Time Frame: From Week 92 to Week 116 for change from baseline in HbA1c, weight loss and reports of severe or documented hypoglycaemic events; and from date of randomization up to Week 116 for any switching from or addition to randomized treatment. ]
  3. Proportion of patients meeting the 4-item composite endpoint at least once during the second 52 weeks of follow-up (Week 53 through Week 104) [ Time Frame: Any assessment from Week 53 to Week 104. ]
  4. Proportion of patients achieving an 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 [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116. ]
  5. The proportion of patients achieving a weight loss 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 [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116. ]
  6. Proportion of patients with no reported severe or documented hypoglycaemic events since randomization at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up. [ Time Frame: At the last clinical assessment between Week 40 to Week 64 and, separately, at the last clinical assessment between Week 92 to Week 116. ]
    Proportion of patients with no reported severe or documented hypoglycaemic events since randomizaton 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).

  7. Change from baseline in 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) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  8. Change from baseline in total body weight 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) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  9. Changes in scores from baseline in the HFS-11 Worry scale at 6, 12, 18 and 24 months [ Time Frame: 6, 12, 18 and 24 months ]
  10. Proportion of patients needing antihypertensive escalation (dose up titration, switch and add-on strategies) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up. [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
    Proportion of patients needing antihypertensive escalation (dose up titration, switch and add-on strategies) 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)

  11. Changes in scores from baseline in the DTSQ scale at 6, 12, 18 and 24 months [ Time Frame: 6, 12, 18 and 24 months ]
  12. Proportion of patients not switching from or adding to the treatment to which the patient was randomized at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up. [ Time Frame: Freedom from switching from or adding to randomized treatment should be over entire study until the last assessment up to Week 64 and, separately, up to Week 116 ]
    Proportion of patients not 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 and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).


Other Outcome Measures:
  1. Change in scores from baseline in the MMAS-8 at 6, 12, 18, and 24 months [ Time Frame: 6, 12, 18, up to 24 months ]
  2. Cumulative number of hospitalizations 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). [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  3. Cumulative number of contacts due to hypoglycaemic events 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) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  4. Proportion of patients needing insulin treatment 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) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  5. Proportion of patients with at least one complication 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 fo 12 weeks) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  6. Cumulative number of patient complications 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) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  7. Cumulative number of unscheduled GP visits 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) [ Time Frame: Between Week 40 to Week 64 and, separately, between Week 92 to Week 116 ]
  8. Change in scores from baseline in the SF36 v2 at 6, 12, 18, and 24 months. [ Time Frame: 6, 12, 18, up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616666


Contacts
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Contact: CPRD Interventional Research +44 (0)20 3080 6383 enquiries@cprd.com
Contact: Susan Beatty 0203 080 7050 susan.beatty@mhra.gov.uk

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

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Responsible Party: Clinical Practice Research Datalink
ClinicalTrials.gov Identifier: NCT02616666     History of Changes
Other Study ID Numbers: D1690R00009
2015-001873-42 ( EudraCT Number )
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Keywords provided by Clinical Practice Research Datalink:
Type 2 diabetes mellitus
Randomised
Pragmatic
Standard of Care
Dapagliflozin
FORXIGA

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs