NCT03164187已完成不适用
Evaluation of Type 2 Diabetes Treatment in AZERbaijan
Servier Affaires Médicales4 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Decrease in HbA1c
研究概览
简要总结
The aim of this study is to analyze the efficacy of Diabeton 60 MR as intensive sugar-lowering therapy into routine clinical practice, in patients for whom the treating physician has already decided to prescribe this medication. This concerns untreated newly diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients:
- •Males and females, aged over 35
- •Currently treated: with diet only, or with metformin therapy for at least 3 months prior to inclusion
- •Who have not been able to achieve target level of glycaemia, with glycated hemoglobin (HbA1c) level exceeding 7%.
排除标准
- •Patients with at least one of the following criteria are not included in the study:
- •Type 1 diabetes
- •Severe liver (ALT and AST levels 2.5 times as high as upper level of normal range) or renal insufficiency (creatinin plasma level above 140 µmole/L)
- •Patients who are on insulin therapy, or at risk to receive an insulin treatment in the next 4 months, according to physician judgment.
- •Intolerance to Gliclazide if such prescription was done in the past
- •Pregnancy and breast-feeding
- •Night workers or patients able to skip meals
- •Presence of any contraindication listed in the SmPC.
研究组 & 干预措施
Diabeton MR 60
干预措施: Diabeton 60 MR (Drug)
结局指标
主要结局
Decrease in HbA1c
时间窗: over 4 months
Percentage of patients achieving HbA1c level ≤ 7 %
时间窗: week 16.
次要结局
- Mean daily dosage of Diabeton MR(Week 2, 4, 6, 8 and 16)
- number of hypoglycemia episodes(Week 0, 2, 4, 6, 8 and week 16.)
研究者
研究点 (4)
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