NCT00952445已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 18
研究概览
简要总结
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
- •Fasting Plasma Glucose between 126 and 240 mg/dL
- •Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
- •Fasting C-peptide > 0.8 ng/mL
排除标准
- •Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
- •Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
- •BMI > 42 kg/m2
- •Presence of any diabetic complications requiring chronic therapy
- •Presence or history of any form of hepatic disease
- •Serum creatinine > 1.8 mg/dL
- •History of cardiac arrhythmias or abnormal cardiac electrophysiology
- •Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol
研究组 & 干预措施
T0903131 Besylate
Experimental
1.0 mg
干预措施: T0903131 Besylate (Drug)
T0903131 Besylate (higher dose)
Experimental
10.0 mg
干预措施: T0903131 Besylate (Drug)
Placebo
Placebo Comparator
Once daily, oral
干预措施: Placebo (Drug)
研究者
研究点 (18)
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