"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"

AstraZeneca1 个研究点分布在 1 个国家目标入组 1,462 人开始时间: 2005年8月最近更新: 2015年4月29日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: AstraZeneca
入组人数: 1,462
试验地点: 1
主要终点: Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24

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研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

详细描述

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitizone added onto their blinded study medication

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

入选标准

•Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
•HbA1c >= 7.0% and <= 10.0 %
•Body mass index <= 40 kg/m2
•Fasting C-peptide >= 1 ng/dL

排除标准

•Symptomatic poorly controlled diabetes
•Recent cardiac or cerebrovascular event
•Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females