104 Week Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study.

Pragmatic Randomised 104 Week Multicentre Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study. - DECIDE

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001873-42-GB

Enrollment

872

Registered

2015-09-01

Start date

2015-10-27

Completion date

Unknown

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 20.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861

Interventions

Trade Name: FORXIGA Product Name: Forxiga Pharmaceutical Form: Film-coated tablet INN or Proposed INN: dapagliflozin propanediol monohydrate CAS Number: 960404-48-2 Other descriptive name: DAPAGLIFLOZ

Eligibility

Sex/Gender

All

Inclusion 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 676 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 196

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months post-randomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint, at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).;Secondary Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months postrandomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint at any clinical evaluation that occurs within the first 52 weeks of follow-up. To assess differences between dapagliflozin and SOC (subsequent to 52 weeks of followup) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint at the clinical evaluation that occurs: - closest to 104 weeks of follow-up (allowing a window of 12 weeks); - and separately, within the second 52 weeks of follow-up (Week 53 through Week 104). Other objectives include evaluation of each separate item of the composite; change from baseline in HbA1c and in total body weight; the patient’s worry related to the risk of hypoglycaemic episodes; the patient’s satisfaction with treatment; and the need for antyhpertensive escalation. ;Primary end point(s): HbA1c reduction vs. baseline (= 0.5%), weight loss vs. baseline (= 2 Kg), no severe or documented hypoglycaemic events since the last (most recent) clinical assessment, and no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC). ;Timepoint(s) of evaluation of this end point: At the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).	—

Measure

Time frame

Main Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months post-randomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint, at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).;Secondary Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months postrandomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint at any clinical evaluation that occurs within the first 52 weeks of follow-up. To assess differences between dapagliflozin and SOC (subsequent to 52 weeks of followup) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint at the clinical evaluation that occurs: - closest to 104 weeks of follow-up (allowing a window of 12 weeks); - and separately, within the second 52 weeks of follow-up (Week 53 through Week 104). Other objectives include evaluation of each separate item of the composite; change from baseline in HbA1c and in total body weight; the patient’s worry related to the risk of hypoglycaemic episodes; the patient’s satisfaction with treatment; and the need for antyhpertensive escalation. ;Primary end point(s): HbA1c reduction vs. baseline (= 0.5%), weight loss vs. baseline (= 2 Kg), no severe or documented hypoglycaemic events since the last (most recent) clinical assessment, and no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC). ;Timepoint(s) of evaluation of this end point: At the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).

—

Secondary

Measure	Time frame
Secondary end point(s): HbA1c reduction vs. baseline (= 0.5%); weight loss vs. baseline (= 2 Kg); no severe or documented hypoglycaemic events since the last (most recent) clinical assessment; no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC); HFS-II Worry scale score; DTSQ score; proportion of patients needing antyhypertensive escalation. ;Timepoint(s) of evaluation of this end point: • At any clinical evaluation that occurs within the first 52 weeks of follow-up. • At the clinical evaluation that occurs closest to 104 weeks of follow-up (allowing a window of 12 weeks). • At any clinical evaluation within the second 52 weeks of follow-up (Week 53 through Week 104).	—

Measure

Time frame

Secondary end point(s): HbA1c reduction vs. baseline (= 0.5%); weight loss vs. baseline (= 2 Kg); no severe or documented hypoglycaemic events since the last (most recent) clinical assessment; no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC); HFS-II Worry scale score; DTSQ score; proportion of patients needing antyhypertensive escalation. ;Timepoint(s) of evaluation of this end point: • At any clinical evaluation that occurs within the first 52 weeks of follow-up. • At the clinical evaluation that occurs closest to 104 weeks of follow-up (allowing a window of 12 weeks). • At any clinical evaluation within the second 52 weeks of follow-up (Week 53 through Week 104).

—

Countries

United Kingdom

Contacts

Public ContactEnquires

Clinical Practice Research Datalink (CPRD)

+44 (0)20 3080 6383

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026