A Randomized, Double-Blind, Comparator-Controlled Study of Pioglitazone HCl vs Glyburide in the Treatment of Subjects With Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild to Moderate Congestive Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 518
- 主要终点
- Progression of Congestive Heart Failure.
研究概览
简要总结
The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure
详细描述
Approximately 16 million people in the United States have been diagnosed with type 2 diabetes, a prevalence rate of approximately 6%, and the numbers are expected to increase with the increasing age of the general population. The risk factors associated with development of type 2 diabetes, such as age, obesity, and diet and exercise habits, also contribute to the development of cardiovascular disease. Additionally, patients with diabetes are at an increased risk for development of microvascular and macrovascular disease.
With regard to congestive heart failure, the risk of congestive heart failure is increased in subjects with diabetes in the absence of coronary artery disease; in subjects with diabetes and established coronary artery disease there is a higher overall risk and greater risk for more severe congestive heart failure. There is evidence that increasing insulin sensitivity and reducing hyperinsulinemia may reduce cardiovascular risks by reducing blood pressure, improving endothelial function, and through cardiac remodeling and function.
Pioglitazone is a thiazolidinedione for the treatment of type 2 diabetes, and is an agonist of the peroxisome proliferator-activated receptor. Pioglitazone received marketing approval in the United States in 1999. As part of the approval process, Takeda fulfilled a postmarketing study evaluating the effects of pioglitazone in the treatment of type 2 diabetes in subjects with congestive heart failure in a6-month clinical study.
An independent Data Safety Monitoring Board used to monitor the overall safety pattern of the study and to conduct unblinded reviews of data found a difference in the composite endpoint of time to first event that approached nominal statistical significance in favor of glyburide. As a result, the committee recommended that Takeda terminate the trial. Consistent with regulatory agency requirements, Takeda is submitting an abbreviated report that focuses on the safety data derived from the terminated study.
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
- 18 Years 至 —（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
Pioglitazone QD
干预措施: Pioglitazone (Drug)
Glyburide QD
干预措施: Glyburide (Drug)
结局指标
主要结局
Progression of Congestive Heart Failure.
时间窗: At First Event.
次要结局
- Change from baseline in Glycosylated Hemoglobin.(Weeks 12, 20 and Final Visit.)
- Change from baseline in Fasting Plasma Glucose.(At All Visits.)
- Change from baseline in Triglycerides.(Weeks 8, 16 and Final Visit.)
- Change from baseline in cholesterol (total cholesterol, high-density lipoprotein and low-density lipoprotein).(Weeks 8, 16 and Final Visit.)
- Change from baseline in 6 Minute Walking test distance(At Final Visit)
- Physician & Subject Congestive Heart Failure Global Assessment Score(At Final Visit)
- Change in New York Heart Association classification(At All Visits.)
- Minnesota Living with Heart Failure Questionnaire total score.(At Final Visit.)
- Changes in blood pressure and heart rate.(At All Visits.)
- All cause mortality.(At First Event.)