NCT00400283已完成1 期
A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.
研究概览
简要总结
This trial is conducted in Europe. A seven day dose escalation study in subjects 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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Diet treatment only for at least two weeks
- •Body mass index (BMI) between 22-34 kg/m2 inclusive
- •HbA1C between 6.5-12.0% inclusive
- •Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
- •Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD)
排除标准
- •Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
- •History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
- •Impaired renal function, serum creatinine greater than 150µmol/L
- •Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
- •Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
- •Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks
- •Patients who had a significant history of alcoholism or drug/chemical abuse
结局指标
主要结局
To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.
次要结局
未报告次要终点
研究者
研究点 (2)
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