DETAIL = Diabetics Exposed to Telmisartan And enalapIL: A Randomised, Double-blind, Parallel-group Comparison of the Renal and Antihypertensive Effects of Telmisartan and Enalapril in Subjects With Mild to Moderate Hypertension and Concurrent Type II Diabetes Mellitus and Diabetic Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 57
- 主要终点
- Change from baseline in glomerular filtration rate GFR after five years of treatment.
研究概览
简要总结
To compare the renal consequences of two different approaches to blocking the renin angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and diabetic nephropathy.
详细描述
The aims of this study were to compare the renal consequences of two different approaches to blocking the activity of the renin angiotensin system - Angiotensin II antagonism with telmisartan and ACE inhibition with enalapril - in patients with hypertension and concurrent type II diabetes mellitus and diabetic nephropathy.
The study was designed to investigate albumin excretion rates in the short term, and in the longer term, to assess the outcome with respect to maintenance of renal function (GFR) and incidence of clinical endpoints.
Study Hypothesis:
Association of Hypertension and Diabetes Essential hypertension accounts for the majority of hypertension in people with diabetes, particularly in those with type II diabetes, who constitute more than 90% of those with a dual diagnosis of diabetes and hypertension.
Both diabetes and hypertension each confer increased cardiovascular risk, and patients with both conditions have more atherogenic risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the ages 35 and 80 years.
- •Current ACE inhibitor therapy for a minimum period of 3 months prior to study entry.
- •Confirmed diagnosis of type II diabetes:
- •Subjects currently treated by diet or diet and oral hypoglycaemic drugs, OR
- •Subjects currently treated with insulin, with a history of onset of diabetes after the age of 40 and a body weight in excess of ideal body weight at the time of diagnosis, and treated with oral agents for a minimum period of two years
- •On treatment diastolic blood pressure of < 95 mmHg.
- •Documentation of a normal renal ultrasound within previous 6 months prior to inclusion (alternate methods eg pyelography, renal isotope method was also acceptable).
- •Mean of three consecutive overnight urinary albumin excretion rates > 20 and < 1000 g/min at the end of the pre-treatment observation period. (A minimum of two of the three samples must be > 20 g/min.)
- •Glycosylated haemoglobin (HbA 1c) < 10%.
- •Serum creatinine < 140 mol/L.
- •Glomerular filtration rate (GFR) > 70 ml/min/1.73 m
- •Ability to provide written informed consent.
排除标准
- •Type I diabetes mellitus.
- •Pre-menopausal women (last menstruation < 1 year prior to start of screening period):
- •Who were not surgically sterile (tubal ligation, hysterectomy) or
- •Who were not practising acceptable means of birth control (and do not plan to continue using this method throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives.
- •Who had a positive serum pregnancy test at baseline.
- •Afro-Caribbean subjects.
- •Mean seated SBP > 180 mmHg.
- •Hepatic dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) > 1.5 times the upper limit of normal.
- •Known causes of renal dysfunction other than diabetic nephropathy.
- •Subjects who had a solitary kidney or known renal artery stenosis.
- •NYHA functional class CHF II - IV.
- •Known drug or alcohol dependency.
- •Subjects receiving any investigational therapy within one month of providing written informed consent.
- •Known hypersensitivity to telmisartan or ACE inhibitors or to any component of the formulation.
- •Subjects with a history of suspected angioedema related to ACE inhibitor therapy.
结局指标
主要结局
Change from baseline in glomerular filtration rate GFR after five years of treatment.
时间窗: 5 years
次要结局
- Change from baseline in GFR after one, two, three and four years of treatment(Baseline, 1,2,3 and 4 years)
- Change from baseline in creatinine(up to 5 years)
- Changes in vital signs (DBP, SBP, pulse rate)(up to 5 years)
- Number of patients with Adverse Events(up to 5 years)
- Physical examination(up to 5 years)
- Clinical laboratory parameters(up to 5 years)
- Incidence of all cause mortality(up to 5 years)
- Percentage change from baseline in urinary albumin excretion rate(up to 5 years)
- Incidence of clinical endpoints (including- end-stage renal disease, myocardial infarction, cerebrovascular accident, congestive heart failure)(up to 5 years)
- Resting 12-lead ECG(up to 5 years)