Multi Center, Open Label Study to Evaluate the Influence of Pioglitazone Treatment Over 6 Months on Metabolic Control in Type II Diabetic Patients Previously Treated With Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value
研究概览
简要总结
The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.
详细描述
To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control.
Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value (screening visit V1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •insulin therapy > 1 year
- •residual ß-cell function (C-peptide increase in iv glucagon test)
- •written informed consent
排除标准
- •type 1 diabetes
- •oral therapy
- •life-threatening disease
- •heart failure (NYHA I-IV)
研究组 & 干预措施
A
pioglitazone/glimepiride
干预措施: pioglitazone and glimepiride (Drug)
结局指标
主要结局
The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value
时间窗: 6 months
次要结局
- Absolute change of HbA1c Insulin resistance according to minimal model and HOMA-S analysis change of insulin resistance according to minimal model and HOMA-S analysis to baseline first phase insulin response(6 months)