NCT01193296已完成4 期
Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
研究概览
简要总结
The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions.
- •HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months
排除标准
- •Age >= 80 years
- •BMI <= 22 and >=40 kg/m2
- •Secondary T2 DM
- •Hepatic failure, ASAT/ALAT>3 ULN, and moderate/severe renal failure (CI < 50 ml/min) CHF III & IV
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Sitagliptin
Active Comparator
干预措施: Sitagliptin (Drug)
Vildagliptin
Experimental
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
时间窗: 8 weeks
次要结局
- Glycemic control assessed through CSGM(8 weeks)
- Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks(8 weeks)
- Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT00542633Biodel472
已完成
不适用
Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)Type1diabetesNCT05708040Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal48
已完成
2 期
A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 DiabetesDiabetes Mellitus, Type 2NCT02053272Jazz Pharmaceuticals207
已完成
不适用
Diabetes teleMonitoring of Patients in Insulin TherapyType 2 Diabetes Treated With InsulinNCT04981808Aalborg University Hospital331
已完成
1 期
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study CompoundsHealthy VolunteersType 2 DiabetesNCT04676906Novo Nordisk A/S18