NCT00924105已完成1 期
A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine (CYT013-IL1bQb) in Patients With Type 2 Diabetes Mellitus
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
- 48
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting Interleukin-1 beta in patients with type 2 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, ≥ 3 months at time of randomization
- •HbA1c in the range of 6.5 - 9.5% (inclusive) at screening
- •Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization
- •Further criteria as defined in the clinical trial protocol
排除标准
- •Symptoms of hyperglycemia (i.e. polyuria and polydypsia)
- •History of significant weight gain or loss (+/-5%) during the 4 weeks before randomization
- •Fasting C-peptide level < 400 pmol/L at screening
- •Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization
- •Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization
- •Current systemic anti-inflammatory therapy other than aspirin ≤ 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids
研究组 & 干预措施
1
Experimental
干预措施: CYT013-IL1bQb (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: continously
次要结局
- Biological measures of glycemia and inflammation(continously)
研究者
研究点 (1)
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