Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) after a testmeal measured CGM.
研究概览
简要总结
Comparison of efficacy and safety of glargine insulin and metformin as first line drug of patients insufficiently treated with lifestyle intervention. So far treatment also algorithm with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion and glycemic variability as determinants of oxidative stress will be measured by continuous glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As secondary objectives effect on endothelial function, renal function and biomarkers of low great inflammation will be evaluated. So far only scarce information on face to face comparison in ealy diabetes exists.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •early type 2 diabetes (lower than 5 years known)
- •male and female(35 to 75 years)
- •HbA1c 7 to 8 %, if drug naive and <= 8.5 with previous OAD intake
- •Informed consent
排除标准
- •any treatment more than one OAD at the same time
- •treatment with one OAD < 6 weeks time
- •insulin treatment
- •acute coronary syndrome < 6 months
- •severe liver disease
- •alcohol abuse or drug addiction
- •severe kidney disease
- •acute critical illness with renal impairment
- •i.v. application of iodine
- •ketoacidosis
- •acute or chronic illness witch may lead to hypoxia or cardial failure
- •allergy against one of the drugs
- •deficit in compliance or cooperation
- •pregnancy or breast feeding
- •women in fertile age without accepted contraceptive
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Insulin glargine
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Area under the curve (AUC) after a testmeal measured CGM.
时间窗: baseline and visit 8
次要结局
- HbA1C, glycemic variability, glycemic load, insulin secretion after testmeal, free fatty acids, biomarkers of low grade inflammation, endothelial dysfunction.(baseline and visit 8)