A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
研究概览
简要总结
The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female in age ≥18 at Visit 1
- •Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
- •HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
- •With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin
排除标准
- •Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1
- •Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
- •Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
- •Pregnant women or breastfeeding women at the time of enrolment
- •Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment
研究组 & 干预措施
LAF237 (vildagliptin) 50mg once daily (QD)
Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
干预措施: LAF237 (vildagliptin) (Drug)
LAF237 (vildagliptin) 50mg once daily (QD)
Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
干预措施: Metformin (Drug)
LAF237 (vildagliptin) 50mg twice daily (BID)
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
干预措施: LAF237 (vildagliptin) (Drug)
LAF237 (vildagliptin) 50mg twice daily (BID)
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
时间窗: Baseline, Month 12 (weeK 52)
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c
次要结局
- Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)(Baseline, Month 3, 6, 9 and 12)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)(Baseline, Month 3, 6, 9 and 12)
- Percentage of Patients Achieving Good Glycemic Control(Month 3, 6, 9, 12)
- Percentage of Overall Drug Compliance in 12 Months(Month 12)
- Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability(Month 12)