NCT01547897已完成2 期
A Phase IIa Study to Characterize the Effects of CCL2 Inhibition With the Spiegelmer® NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
TME Pharma AG0 个研究点目标入组 76 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
研究概览
简要总结
Primary objective:
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
Secondary objectives:
- To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)
- To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function
- To assess the safety and tolerability of study drug
- To determine the population pharmacokinetics (PK) of study drug
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
- Triple (Participant, Care Provider, Investigator)
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
- •Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
- •HbA1c between 6.0% and 10.5%, inclusive
- •ACR > 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements > 100 mg/g
- •Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
- •Stable treatment with angiotensin-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin-angiotensin system [RAS] blockade)
- •Willing and able to understand and sign an approved Informed Consent form
- •Men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Women must be of non-childbearing potential.
排除标准
- •Type 1 diabetes mellitus
- •Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- •Recent cardiovascular events (3 months)
- •Uncontrolled hypertension (upper limits 180/110 mmHg)
- •Dialysis and/or acute kidney injury within 3 months before screening
- •Significant edema, infectious diseases, leg ulcers
- •Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study
- •Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit
- •Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- •In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit
- •Use of thiazolidinedione class drugs, immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors, two or more diuretic drugs and/or aliskiren
- •In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study.
- •Previous participation in this study.
研究组 & 干预措施
NOX-E36
Active Comparator
干预措施: NOX-E36 (Drug)
Placebo
Placebo Comparator
干预措施: NOX-E36 (Drug)
结局指标
主要结局
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
时间窗: Change versus baseline after 12 weeks treatment
ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
次要结局
- Effect of NOX-E36 on hsCRP(Change versus baseline after 12 weeks treatment)
- Effect of NOX-E36 on HbA1C(Change versus baseline after 12 weeks treatment)
- Effect of NOX-E36 on HOMA-IR(Change versus baseline after 12 weeks treatment)
- Effect of NOX-E36 on eGFR(Change versus baseline after 12 weeks treatment)
研究者
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