Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 225
- 试验地点
- 3
- 主要终点
- Changes in nighttime blood pressure
研究概览
简要总结
Centres: Three university hospitals and the primary care centres in their area in Madrid (Clínico San Carlos, La Paz, 12 de Octubre) Type of study: Randomized, multicentric, placebo-controlled, single-blind pilot study Main outcome: Nighttime blood pressure in type 2 diabetic patients Objective: To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients withalbuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2..
Patients: 225 patients with a previous diagnosis of type 2 diabetes and eGFR> 30mL/min x1,73m2, office BP above 140/70 mmHg, HbA1C 7.5-10%, albuminuria levels between 30 mg/g creatinine and 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.
Intervention: 10 mg once daily of dapagliflozin or placebo resembling dapagliflozin.
详细描述
Effect of dapagliflozin on nighttime blood pressure in type 2 diabetes
TYPE OF STUDY: Randomized, multicentric, placebo-controlled, single-blind pilot study.
CENTRES: Three university hospitals and the primary care centres in their area in Madrid (Clínico San Carlos, La Paz, 12 de Octubre)
PRIMARY OBJECTIVE:
To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients with albuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a previous diagnosis of type 2 diabetes and
- •Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min x1.73m2and
- •Diagnosis of essential hypertension established at least one year before inclusion visit and suboptimal BP control (office BP above 140/70 mmHg)
- •HbA1C 7.5-10%
- •Albuminuria levels ≥ 30 mg/g of creatinine
排除标准
- •Age < 18 years old or ≥ 75 years old.
- •Women of childbearing potential. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •Type 1 diabetes
- •Albuminuria above 3000 mg/g of creatinine
- •Established cardiovascular disease (stable heart failure, peripheral arterial disease or myocardial infarction or stroke within the previous 6 months)
- •Intolerance to dapagliflozin
- •On treatment with loop diuretic
- •On treatment with SGLT2 inhibitors.
- •On treatment with pioglitazone.
- •Patients diagnosed of hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Patients who routinely work during nightime (period between 11.00 p.m. and 7.00 a.m.)
研究组 & 干预措施
Dapagliflozin
The investigational medicinal product (IMP) is Dapagliflozin 10 MG Oral Tablet [Farxiga] given once daily (film coated tablets, oral use).
Dapagliflozin 10 MG Oral Tablet [Farxiga] will be administered through out the planned intervention period of the study (12 weeks).
Dosage form and strength: 10 mg, Green, plain, diamond shaped, film coated tablet (orally)
干预措施: Dapagliflozin 10 MG Oral Tablet [Farxiga] (Drug)
Placebo matching dapagliflozin
The comparator will be placebo oral tablet matching dapagliflozin 10 mg. Placebo will be administered through out the planned intervention period of the study (12 weeks).
Dosage form and strength: Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Changes in nighttime blood pressure
时间窗: 12 weeks
Changes in mean nighttime blood pressure (systolic and diastolic) between baseline and last visit (units: mmHg)
次要结局
- Changes in office blood pressure. Both systolic and diastolic blood pressure will be assessed(12 weeks)
- Changes in albuminuria(12 weeks)
- Changes in HBA1C(12 weeks)