A Phase 3b, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Pioglitazone HCl and Metformin HCl Fixed-Dose Combination Therapy Compared to Pioglitazone HCl Monotherapy and to Metformin HCl Monotherapy in the Treatment of Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- Percent Change From Baseline in Glycosylated Hemoglobin
研究概览
简要总结
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.
详细描述
Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism.
Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents.
This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.
Study participation is anticipated to be approximately 6.5 months.
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 15 mg /Metformin 850 mg BID
干预措施: Pioglitazone and metformin (Drug)
Pioglitazone 15 mg BID
干预措施: Pioglitazone (Drug)
Metformin 850 mg BID
干预措施: Metformin (Drug)
结局指标
主要结局
Percent Change From Baseline in Glycosylated Hemoglobin
时间窗: Baseline and Week 24
The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.
次要结局
- Change From Baseline in Fasting Plasma Glucose(Baseline and Week 24)
- Change From Baseline in Fasting Insulin(Baseline and Week 24)
- Change From Baseline in Homeostasis Model Assessment - Insulin Resistance(Baseline and Week 24)
- Median Percent Change From Baseline in High Sensitivity C-reactive Protein(Baseline and Week 24)
- Change From Baseline in Adiponectin(Baseline and Week 24)
- Change From Baseline in Total Cholesterol(Baseline and Week 24)
- Change From Baseline in Low-Density Lipoprotein Cholesterol(Baseline and Week 24)
- Change From Baseline in High-Density Lipoprotein Cholesterol(Baseline and Week 24)
- Change From Baseline in Triglycerides(Baseline and Week 24)
- Change From Baseline in Mean Low Density Lipoprotein Particle Concentration(Baseline and Week 24)
- Change From Baseline in Mean Low Density Lipoprotein Particle Size(Baseline and Week 24)
- Change From Baseline in Large Low Density Lipoprotein (L3) Concentration(Baseline and Week 24)
- Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration(Baseline and Week 24)
- Change From Baseline in Medium-Small Low Density Lipoprotein Concentration(Baseline and Week 24)
- Change From Baseline in Small Low Density Lipoprotein Concentration(Baseline and Week 24)
- Change From Baseline in Very Small Low Density Lipoprotein Concentration(Baseline and Week 24)
- Change From Baseline in Mean High Density Lipoprotein Particle Concentration(Baseline and Week 24)
- Change From Baseline in Mean High Density Lipoprotein Particle Size(Baseline and Week 24)
- Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration(Baseline and Week 24)
- Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration(Baseline and Week 24)
- Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration(Baseline and Week 24)
- Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration(Baseline and Week 24)
- Change From Baseline in Mean Very Low Density Lipoprotein Particle Size(Baseline and Week 24)
- Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration(Baseline and Week 24)
- Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration(Baseline and Week 24)
- Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration(Baseline and Week 24)