NCT01398267已完成1 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Aleglitazar 150 µg in Type 2 Diabetic Patients Treated With Lisinopril 20 mg on Renal Function, the Renin-angiotensin System and the Pharmacokinetics of Lisinopril
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Glomerular filtration rate (mGFR), measured as iohexol clearance
研究概览
简要总结
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients, 18 to 65 years of age, inclusive
- •Diabetes mellitus Type 2, diagnosed at least 3 months before screening
- •Treated with stable dose of metformin for at least 4 weeks prior to screening
- •Treated with stable dose of Angiotensin-converting enzyme inhibitor (ACEI) for at least 4 weeks prior to screening
- •Body mass index (BMI) 18 to 38 kg/m2, inclusive
排除标准
- •Positive for HIV-1, HIV-2, hepatitis B or hepatitis C infection
- •Pregnant or lactating females
- •Type 1 diabetes or secondary from of diabetes
- •History or evidence of proliferative diabetic retinopathy or clinically significant neuropathy
- •Clinically significant hepatic disease
- •Clinically significant renal impairment
- •History or evidence of clinically significant cardio-vascular disease or disorder
- •Acute infection or current malignancy requiring treatment except for excised basal cell carcinoma
研究组 & 干预措施
1
Experimental
干预措施: aleglitazar (Drug)
1
Experimental
干预措施: lisinopril (Drug)
2
Placebo Comparator
干预措施: lisinopril (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Glomerular filtration rate (mGFR), measured as iohexol clearance
时间窗: 4 weeks
次要结局
- Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])(4 weeks)
- High density lipoprotein-cholesterol (HDL-C) blood levels(4 weeks)
- Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)(4 weeks)
- Renin-angiotensin system: plasma renin/aldosterone levels)(4 weeks)
- Electrolyte blood/urine concentrations(4 weeks)
- Anti-diuretic hormone (ADH) blood levels(4 weeks)
- Safety: Incidence of adverse events(up to 18 weeks)
- Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])(4 weeks)
- Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril(4 weeks)
研究者
相似试验
已完成
1 期
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective DisorderSchizophreniaNCT01116830Hoffmann-La Roche29
已完成
1 期
A Study of Aleglitazar in Combination With Aspirin in Healthy VolunteersHealthy VolunteerNCT01188304Hoffmann-La Roche44
已完成
1 期
A Study of Aleglitazar in Combination With Ibuprofen in Healthy VolunteersHealthy VolunteerNCT01188317Hoffmann-La Roche44
已完成
2 期
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant TherapyMajor Depressive DisorderNCT01437657Hoffmann-La Roche319
已完成
2 期
A Study of RO4917523 in Pediatric Patients With Fragile X SyndromeFragile X SyndromeNCT01750957Hoffmann-La Roche47