临床试验/NCT00871936

NCT00871936已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of SLx-4090 in Combination With Metformin in Subjects With Type 2 Diabetes

Response Pharmaceuticals0 个研究点目标入组 82 人开始时间: 2009年4月最近更新: 2023年11月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 82
主要终点: Reduction in HbA1c

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.

详细描述

HbA1c after 12 weeks
FPG after 12 weeks
Safety and tolerability
Plasma levels of SLx-4090

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•HbA1c 7-11%
•On a stable dose of metformin for at least 6 weeks

排除标准

•Type 1 Diabetes
•Antidiabetic medication other than or in addition to metformin
•FPG > 270 mg/dL

研究组 & 干预措施

1

Experimental

SLx-4090 in combination with Metformin

干预措施: SLx-4090 (Drug)

1

Experimental

SLx-4090 in combination with Metformin

干预措施: Metformin (Drug)

2

Other

Placebo

干预措施: Placebo (Other)

2

Other

Placebo

干预措施: Metformin (Drug)

结局指标

主要结局

Reduction in HbA1c

时间窗: 12 weeks

次要结局

Adverse Events(12 weeks)

研究者

发起方

Response Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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