CTRI/2022/10/046453招募中Unknown
A Multicentric Active Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 9
- 主要终点
- Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24
研究概览
简要总结
A Multicentric Active Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients conducted on approximately on 210 patients from approximately 14 clinical sites. There are three visits in the study and study duration is of 168 days (24 weeks)+/- 2 week window period.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The inclusion criteria are in accordance with the approved prescribing information and the subjects meeting all of the criteria will be included: 1.Male and female patients above 18 years of age.
- •2.Type 2 diabetes mellitus patients prescribed Vildagliptin 100mg SR once daily formulation by the treating physician as per the approved prescribing information and in accordance with the clinical practice.
- •3.Patients willing to sign patient authorization form (PAF).
排除标准
- •The exclusion criteria are in accordance with the approved prescribing information and the subjects meeting any of the criteria will be excluded:
- •Known case of type 1 Diabetes Mellitus (DM)
- •Known history of any acute metabolic diabetic complications such as ketoacidosis
- •Patients with known history of heart failure NYHA functional class IV
- •Patients with known history of hepatic impairment including patients with a pretreatment ALT or AST >2.5X the upper limit of normal
- •Patients with known history of moderate or severe renal impairment or End Stage Renal Disease (ESRD)
- •Patient with known hypersensitivity to Vildagliptin or to any of the excipients.
结局指标
主要结局
Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24
时间窗: Baseline to week 24
次要结局
- Change in HbA1c, FPG, LFT (AST and ALT), Serum Creatinine, Serum Amylase, Serum Lipase from baseline to week 24.(Baseline to week 24)
研究者
研究点 (9)
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