A Multicentre Randomised Open-Label Crossover 2-Period 2 Treatment Clinical Trial to Evaluate Effect of Dapagliflozin 10 mg Once Daily on the Quality of Life in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 主要终点
- Composite endpoint including quality of life score
研究概览
简要总结
This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV study.
The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.
详细描述
The study will comprise the following phases: Screening, Treatment Period 1 and Treatment Period 2.
After screening examinations and assessments, all patients enrolled will be randomly assigned in equal proportion (1:1) to either study arm:
Arm 1:
- Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks during Treatment Period 1
- Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks during Treatment Period 2
Arm 2 (the same treatment phases in reverse order):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study patients should fulfil ALL the criteria listed below:
- •A voluntary informed consent form for participation in the study signed by the patient prior to any study-specific procedures
- •Male and female patients of 18-74 years of age
- •Diagnosed type 2 diabetes
- •Therapy with metformin at a stable dose ≤1,500 mg/day for at least 8 weeks before enrolment
- •HbA1c >7.0% and ≤10% at the Screening Visit
- •C-peptide ≥1.0 ng/ml at the Screening Visit
- •Body mass index ≤45.0 kg/m² at the Screening Visit
- •For women of childbearing potential - use of reliable birth control methods
- •Ability to complete study-specific procedures
- •Ability to complete questionnaires
排除标准
- •Type 1 diabetes
- •Diabetic ketoacidosis at Screening
- •AST and/or ALT > 3 × upper limit of normal at Screening
- •Total serum bilirubin > 34.19 μmol/l at Screening
- •Decompensated diabetes mellitus (HbA1c >10% at Screening)
- •Patients with moderate to severe renal impairment (CrCl <60 ml/min or <60 ml/min/1.73 m2 at Screening) or terminal renal insufficiency
- •Severe concomitant diseases or severe cardiovascular, renal, hepatic, hematologic, endocrine, mental or rheumatic pathology
- •Malignancy within 5 years before enrolment
- •Acute (including viral and infectious) diseases within 1 month before the Screening Visit.
- •Development of severe acute diseases during the study which significantly affect the benefit/risk ratio for the subject or affecting study efficacy/safety assessment criteria
- •History of acute myocardial infarction or stroke within 6 months before the Screening Visit or during the study. Heart failure (NYHA III-IV)
- •Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the Screening Visit.
- •For women of childbearing potential - a positive pregnancy test or the patient is breast-feeding or planning pregnancy during the study
- •History of Hepatitis B and C or HIV
- •Individual hypersensitivity to any component of the investigational product (dapagliflozin)
- •Treatment with sodium-dependent glucose cotransporter inhibitors (SGLT2) has been administered within 3 months prior to enrolment or is planned during the study.
- •Loop diuretics have been administered for 3 months before the Screening Visit or are planned during the study.
- •Hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption
- •The patient is unable to follow study procedures and attend the study centre for scheduled study visits or is going to relocate within the protocol-specific timelines
- •The patient is a subject of other studies within 3 months before enrolment
研究组 & 干预措施
Arm 2
Arm 2 - metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks (Treatment Regimen 2) followed by therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks (Treatment Regimen 1)
干预措施: Metformin (Drug)
Arm 1
Arm 1 - therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks (Treatment Regimen 1) followed by metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks (Treatment Regimen 2)
干预措施: Dapagliflozin (Drug)
Arm 1
Arm 1 - therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks (Treatment Regimen 1) followed by metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks (Treatment Regimen 2)
干预措施: Metformin (Drug)
Arm 2
Arm 2 - metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks (Treatment Regimen 2) followed by therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks (Treatment Regimen 1)
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Composite endpoint including quality of life score
时间窗: 48 weeks
Change in the overall quality of life, obesity-specific quality of life and treatment satisfaction in the course of the therapy by the end of each 24-week treatment period compared to the quality of life, obesity-specific quality of life and treatment satisfaction at baseline.
次要结局
- Proportion of patients(48 weeks)
- Change in fasting plasma glucose(48 weeks)
- Change in HbA1c level(48 weeks)
- Change in waist circumference(48 weeks)
- Change in body weight(48 weeks)