An Open-label, Randomized, Active-controlled Study to Compare the Effect of DPP-IV Inhibitor and TZD as add-on Therapy to Metformin on Glycemic Variability and Oxidative Stress in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Glycemic Variability
研究概览
简要总结
The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.
详细描述
Activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. Dipeptidyl peptidase IV (DPP-IV), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. We believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.
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
- •Male or female with age 18-80 years
- •Type 2 diabetes mellitus
- •On stable dose of metformin (more than 1000mg) for at least 1 month
- •HbA1c 7~10%
- •Subjects on statins, ACE inhibitors, ARBs and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study
- •BP under control - no change required to BP medications
- •Agreement to maintain prior diet & exercise
排除标准
- •Type 1 DM or Any kind of secondary DM
- •Pregnant or lactating women.
- •Treatment with sulfonylurea, α-glucosidase inhibitor, glinide, GLP-1 analogues, DPP-IV inhibitors or insulin therapy within 1 month prior to informed consent.
- •Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent.
- •HbA1c <7% or >10%
- •Uncontrolled hypertension ( BP > 160/100 mmHg)
- •Congestive heart failure (NYHA class I to IV).
研究组 & 干预措施
Pioglitazone
pioglitazone: 15mg, QD, PO, 16 weeks
干预措施: pioglitazone (Drug)
vildagliptin
vildagliptin 50mg,BID,PO,16 weeks
干预措施: Galvus (vildagliptin) (Drug)
结局指标
主要结局
Glycemic Variability
时间窗: 16 weeks
次要结局
- Oxidative stress(16 weeks)
- HbA1C(16 weeks)
- hypoglycemia(16 weeks)