临床试验/NCT00484419

NCT00484419已完成3 期

Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy

Daiichi Sankyo0 个研究点目标入组 169 人开始时间: 2007年5月最近更新: 2016年10月4日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Daiichi Sankyo
入组人数: 169
主要终点: Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint

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

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

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: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

排除标准

•Subjects currently treated with a thiazolidinedione are excluded.

研究组 & 干预措施

rosiglitazone

Active Comparator

rosiglitazone maleate 4mg

干预措施: rosiglitazone maleate (Drug)

colesevelam

Experimental

colesevelam tablets 625 mg

干预措施: Colesevelam HCl (Drug)

sitagliptin

Active Comparator

sitagliptin phosphate tablets

干预措施: sitagliptin phosphate (Drug)

结局指标

主要结局

Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint

时间窗: 16 weeks change = week 16 - week 0.

Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.

次要结局

Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean(16 weeks change = week 16 - week 0.)
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8(8 weeks change = week 8- week 0.)
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean(8 weeks change = week 8- week 0.)
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean(16 weeks change = week 16 - week 0.)
Mean Change in FPG From Week 0(Baseline) to Week 8(8 weeks change = week 8- week 0.)
Mean Change in FPG From Week 0(Baseline) to Week 16(16 weeks change = week 16 - week 0.)
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean(8 weeks change = week 8- week 0.)
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean(16 weeks change = week 16 - week 0.)
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8(8 weeks change = week 8- week 0.)
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16(16 weeks change = week 16 - week 0.)
Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean(16 weeks change = week 16 - week 0.)
Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16(16 weeks change = week 16 - week 0.)
Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16(16 weeks change = week 16 - week 0.)
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean(16 weeks change = week 16 - week 0.)
Mean Change in LDL-C From Week 0(Baseline) to Week 16(16 weeks change = week 16 - week 0.)
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16(16 weeks change = week 16 - week 0.)
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)(16 weeks change = week 16 - week 0.)

研究者

发起方

Daiichi Sankyo

申办方类型

Industry

责任方

Sponsor

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