NCT00349427已完成3 期
A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
研究概览
简要总结
This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rosiglitazone
Experimental
4mg
干预措施: Rosiglitazone 4 mg (Drug)
Rosiglitazone placebo
Placebo Comparator
4mg
干预措施: Rosiglitazone 4 mg (Drug)
结局指标
主要结局
glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
时间窗: 24 weeks
次要结局
- glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks(8, 16, and 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty LiverChronic Hepatitis C InfectionFatty LiverNCT00274495Beth Israel Medical Center30
已完成
3 期
Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT00428090GlaxoSmithKline862
已完成
2 期
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic SteatohepatitisNon Alcoholic SteatohepatitisNCT00492700Association pour la Recherche sur les Maladies Hépatiques Virales63
已完成
2 期
Placebo and Active Controlled Study of Rivoglitazone in Type 2 DiabetesType 2 DiabetesNCT00143520Daiichi Sankyo441
已完成
3 期
Rosiglitazone And Plaque Study for Type 2 Diabetes MellitusNon-insulin-dependent Diabetes MellitusNCT00231387GlaxoSmithKline60