NCT01664676已完成4 期
A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
研究概览
简要总结
Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities.
- •Male gender
- •T2DM, diagnosed according to international guidelines
- •Age 20-60 years, both included
- •Body Mass Index (BMI): 20-32 kg/m2, both included
- •Metformin treatment
- •Albumin/creatinine ratio <25 mg/mmol
排除标准
- •Known or suspected allergy to trial product or related products
- •Previous participation in this trial
- •Previous treatment with GLP-1 analogues or DPP-4 inhibitors
- •Current treatment with any antidiabetic drug other than metformin
- •Poorly regulated glycemic control (HbA1c > 8%)
- •Impaired kidney function: estimated GFR < 70ml/min
- •Impaired liver function: liver parameters exceed 2 times upper normal limit
- •Subjects with active malignancy
- •Severe cardiac insufficiency classified according to NYHA III-IV
- •Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
- •Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg
- •Antihypertensive treatment consisting of more than two different pharmaceutical products
- •Symptoms related to benign prostate hyperplasia
- •Claustrophobia
- •Any metal body implants
- •History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine neoplasia syndrome type 2
- •Personal or family history of medullary thyroid carcinoma
- •Any diseases judged by the investigator that could affect the trial
- •Any medication judged by the investigator that could affect the trial
研究组 & 干预措施
Liraglutide
Experimental
1.2 mg liraglutide sc. (single-dose)
干预措施: Liraglutide (Drug)
Placebo-liraglutide
Placebo Comparator
Placebo liraglutide sc. (single-dose)
干预措施: Placebo-liraglutide (Drug)
结局指标
主要结局
Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
时间窗: 10-15 hours post-dose
次要结局
- Renal Blood Flow (functional magnetic resonance imaging)(15 hours post-dose)
- Renal electrolyte clearance(10-15 hours post-dose)
- Excretion of kidney injury markers(0-10 hours and 10-15 hours post-dose)
- Plasma concentrations of various hormones(10-15 hours post-dose)
研究者
研究点 (1)
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