NCT00353691已完成3 期
Glimepiride Versus Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus: A Single Blind Comparison Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value.
研究概览
简要总结
To compare the change in glycemic control from baseline to endpoint (last available posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes receiving either glimepiride or metformin as monotherapy.
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
- Single
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value.
次要结局
- Responder rate, defined as proportion of subjects with HbA1c < 7.0% at Week 24 or last evaluable on-therapy observation
- Mean change in fasting plasma glucose (FPG) from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.
- Change in HbA1c from baseline to Week 12
- Mean change in fasting SMBG from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.
- Percent completers, defined as subjects who continued study medication until completion of all requirements of Visit 6 (Week 18)
- Mean change in lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) from baseline to Wk 24 or last evaluable on-treatment value.
- Mean change in body mass index (BMI) from baseline to Wk 12 and Wk 24 or last evaluable on-treatment value
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately ControlledType 2 Diabetes MellitusNCT01699932Sanofi167
进行中（未招募）
不适用
Effect of glimepiride on glycemic control in patients with typ 2 diabetes treated with insulin and metfromiPatients with type 2 diabetes, who are treated with insulin and metformin .EUCTR2008-001092-29-SEKarolinska Institutet, Department of Clinical Sciences, Danderyd Hospital. Division of internal medi
已完成
3 期
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes PatientsDiabetes Mellitus, Type 2NCT01459809Sanofi538
已完成
1 期
Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mgHealthyNCT00934323Handok Inc.33
已完成
1 期
Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mgHealthyNCT00934817Handok Inc.36