NCT01910194已完成2 期
A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- AUCISEC(0-10min)
研究概览
简要总结
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
详细描述
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists
- •Inadequately controlled diabetes mellitus
排除标准
- •Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
研究组 & 干预措施
Lyxumia
Other
4 weeks Luxumia plus another 4 weeks combination
干预措施: Luyxumia versus Lantus (Drug)
Lantus
Other
4 weeks Lantus plus another 4 weeks combination
干预措施: Luyxumia versus Lantus (Drug)
结局指标
主要结局
AUCISEC(0-10min)
时间窗: Within 0 to 10 min after iv glucose challenge
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Gan & Lee Insulin Glargine Target Type (1) Evaluating ResearchDiabetes Mellitus, Type 1NCT03371082Gan and Lee Pharmaceuticals, USA576
已完成
3 期
Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DMType 2 DiabetesNCT02058147Sanofi1,170
进行中（未招募）
1 期
Effect of insulin glargine and lixisenatide versus insulin glargine on brain insulin sensitivity in patients with type 2 diabetesEUCTR2018-003557-21-DEniversity Hospital Tuebingen40
招募中
不适用
Effect of insulin glargine and lixisenatide and insulin degludec and liraglutide on glucose variability and oxidative stress in type 2 diabetes patientsType 2 diabetes mellitusJPRN-UMIN000043068Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine30
已完成
2 期
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic PatientsType 2 Diabetes MellitusNCT01476475Sanofi323