A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study)
概览
- 阶段
- 4 期
- 干预措施
- Dapagliflozin
- 疾病 / 适应症
- Type 2 Diabetes Mellitus
- 发起方
- University of Liverpool
- 入组人数
- 632
- 试验地点
- 115
- 主要终点
- Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)
详细描述
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)
研究者
入排标准
入选标准
- •For inclusion in the study patients should fulfil the following criteria at the time of screening:
- •Provision of informed consent prior to any study specific procedures
- •Females and males aged ≥18 years up to ≤ 75 years
- •Diagnosed with Type 2 Diabetes Mellitus.
- •Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c \> 6.5%.
- •Ability to read and write as judged by the investigator.
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Previous enrolment or randomization in the present study
- •Age \> 75 years
- •Pregnancy/active breast feeding at the time of inclusion
- •Known moderate to severe renal impairment (eGFR\<60ml/min).
- •Participation in an interventional clinical trial ≤ 3 months before enrolment.
- •Unsuitable to participate on mental health grounds, as judged by the investigator.
- •Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.
- •Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.
研究组 & 干预措施
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.
干预措施: Dapagliflozin
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.
干预措施: Standard of Care
结局指标
主要结局
Proportion of patients achieving clinical success as measured by a 4-item composite endpoint.
时间窗: 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).
次要结局
- To assess differences between dapagliflozin and SOC in the proportion of patients needing antihypertensive escalation (dose up titration, switch and add-on strategies),(up to 52 weeks following randomization and separately, up to 104 weeks following randomization.)
- 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(up to 52 weeks following randomization and separately, up to 104 weeks following randomization.)
- 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(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(At 6, 12, 18 and 24 months)
- To assess differences between dapagliflozin and SOC in the change from baseline in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)(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 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).(From randomization to 104 weeks of follow up.)
- 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, 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 proportion of patients not switching from or adding to the treatment to which the patient was randomized ((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 proportion of patients with diabetic complications:(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 eGFR(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 (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).(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).(Up to 52 weeks following randomization and separately, up to 104 weeks following randomization (in both cases, allowing a window of 12 weeks).)