NCT02545738已完成4 期
Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in albuminuria
研究概览
简要总结
The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes.
详细描述
Initial findings point to a clinically significant antiproteinuric effect of liraglutide treatment, possibly independent from blood pressure reduction. The mechanism behind is unclear and the magnitude of albuminuria reduction needs to be verified. Antiproteinuric effects are usually renoprotective and potentially also cardioprotective and may suggest an additional benefit from liraglutide treatment.
The aim of this study is to evaluate the magnitude of the antiproteinuric effect of short-term liraglutide treatment (12 weeks) in patients with type 2 diabetes and albuminuria. In addition, possible mechanisms causing the antiproteinuric effect will be explored.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
- •Male or female patients >18 years with type 2 diabetes (WHO criteria).
- •HbA1c ≥ 48 mmol/mol (6.5 %)
- •eGFR ≥ 30 ml/min/1.73 m2 (estimated by MDRD formula)
- •Fertile female patients must use chemical, hormonal or mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomi or have been surgically sterilized or hysterectomised at least six months prior to screening
- •Patients must be on stable RAAS-blocking treatment (unchanged dose 4 weeks before inclusion)
- •Geometic mean urine albumin-to-creatinine ratio (UACR) above 30 mg/g at screening (measured in at least two of three consecutive morning spot urine samples)
- •Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening.
- •Patients must be on stable glucose lowering medication for at least two weeks before the first visit.
- •Must be able to communicate with the investigator.
排除标准
- •SBP > 180 mm Hg at screening
- •Type 1 diabetes mellitus
- •Chronic pancreatitis / previous acute pancreatitis
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, which in the investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
- •Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
- •Inflammatory bowel disease
- •Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
- •Previous bowel resection
- •Body mass index <18.5 kg/m2
- •Females of childbearing potential who are pregnant, breast-feeding, intending to become pregnant or not using adequate contraceptive methods
- •Clinical signs of diabetic gastroparesis
- •Impaired liver function (transaminases > two times upper reference levels)
- •The receipt of any investigational product 90 days prior to this trial
- •Known or suspected abuse of alcohol or narcotics
- •Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
研究组 & 干预措施
Liraglutide
Experimental
Liraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.
干预措施: Liraglutide (Drug)
Placebo
Placebo Comparator
Placebo s.c. for 12 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Change in albuminuria
时间窗: 24 weeks
24h urinary albumin excretion rate (UAER mg/24h)
次要结局
- Change in 24h blood pressure(24 weeks)
- Change in kidney function(24 weeks)
- Change in renin-angiotensin system hormones(24 weeks)
- 24h heart rate(24 weeks)
- Change in markers of inflammation(24 weeks)
研究者
Peter Rossing
Professor
Steno Diabetes Center Copenhagen
研究点 (1)
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