The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- The change of HbA1c
研究概览
简要总结
Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.
Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical practice. It is well established that DPP-IV inhibitor improve glycemic control in patients with type 2 diabetes.
But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c ≥ 7%
排除标准
- •Contraindication to Vildagliptin
- •Pregnant or breast feeding women
- •Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- •Chronic hepatitis B or C (except healthy carrier of HBV)
- •Liver disease (AST/ALT > 3-fold the upper limit of normal)
- •Renal failure (Cr > 2.0)
- •Cancer within 5 years
- •Not appropriate for oral antidiabetic agent
- •Medication which affect glycemic control
- •Disease which affect efficacy and safety of drugs
- •Other clinical trial within 30 days
研究组 & 干预措施
Vildagliptin
Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin
干预措施: Vildagliptin (Drug)
Sulphonylurea dose-up
Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin
干预措施: Sulphonylurea dose-up (Drug)
结局指标
主要结局
The change of HbA1c
时间窗: 24weeks
次要结局
- Fasting Plasma Glucose (FPG)(24 weeks)
- HbA1c < 7.0% without hypoglycemia(24 weeks)
- Hypoglycemia(24 weeks)
- Postprandial Plasma Glucose (PPG)(24 weeks)
- Body weight(24 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital