NCT00675857已完成2 期
A Phase IIa Study of the Safety and Clinical Proof-of-concept of NC-503 (Eprodisate Disodium) in Patients With Type II Diabetes and Features of Metabolic Syndrome
Bellus Health Inc. - a GSK company0 个研究点目标入组 200 人开始时间: 2008年4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
- 200
- 主要终点
- Change from baseline to Week 26 in HbA1c levels
研究概览
简要总结
The main objectives of the current study are to establish the safety and clinical proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent.
详细描述
Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and gender eligibility: 30 years and older
- •Diagnosis of Type 2 diabetes mellitus
- •Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the Screening visit
- •Patients must have HbA1C level between 7.0-10.0 %, inclusively at screening
- •The participant must have central obesity (Waist circumference) defined per country/ethnic group: Europids: men ≥ 94 cm, women ≥ 80 cm; South Asian, Chinese & Japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
- •Reduced HDL cholesterol ≤ 1.0 mmol/L
- •Hypertriglyceridemia ≥ 1.7 mmol/L or treatment for dyslipidemia
- •Hypertension: ≥ 130/85 mm Hg blood pressure or treatment with antihypertensive medication.
- •Patients must have a Glomerular Filtration Rate (GFR) of ≥ 60 mL/min, and no history of dialysis.
排除标准
- •Patients having received insulin, thiazolidinediones (TZDs) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
- •Has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease
- •Patients who have an increased red blood cell (RBC) turn-over or Thalassemia or anemia
- •Known HIV or history of viral hepatitis type B or C.
- •Any type of diabetes other than Type 2 diabetes
- •Significant hepatic enzyme elevation
- •Body mass index (BMI) of > 40kg/m2
- •Current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening
研究组 & 干预措施
A
Placebo Comparator
干预措施: placebo (Other)
B
Active Comparator
干预措施: NC-503 (eprodisate disodium) (Drug)
结局指标
主要结局
Change from baseline to Week 26 in HbA1c levels
时间窗: 26 weeks
次要结局
- Change in HbA1c levels(26 weeks)
- The rate of achieving glycemic control(26 weeks)
- Change in fasting serum glucose levels(26 weeks)
研究者
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