Post-approval, Observational study to assess safety and effectiveness of Sitagliptin+Glimepiride+Metformin in patients with diabetes on dual therapy in real-life settings of India.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment.
研究概览
简要总结
Post-approval, Observational study to assess safety and effectiveness of Sitagliptin + Glimepiride + Metformin in patients with diabetes on dual therapy in real-life settings of India.
Objective: To study the clinical impact of triple drug combination of Sitagliptin + Glimepiride + Metformin in patients with diabetes on dual therapy.
Primary Endpoint:
Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment.
Mean change in FBG and 1&2-h PPG levels from baseline to 4 ± 1 and 12 ± 1 weeks follow-up.
Mean change in weight after 12 ± 1 weeks of treatment from baseline.
Drug-Dose utilization pattern.
Secondary Endpoints:
Treatment adherence and compliance.
Safety assessment and tolerability.
Physician’s Global Assessment for improvement and user experience.
Duration of observation: 12 weeks
Criteria for evaluation:
HbA1c level to be assessed at 12 ± 1 weeks.
FBG and 1&2-h PPG levels to be assessed at 4± 1 and 12 ± 1 weeks.
Treatment responders with HbA1c less than or equal to 7% or FBG <110 mg/dl or PPG <160 mg/dl at 12 ± 1 weeks in cases with CV risk as assessed by Q-Risk scale for Risk factor (more than or equal to 3), Comorbidities (CKD or PAD or Stroke), Family history, Current status for Micro &/or Macrovascular complications.
Safety: WHO classified safety variables for Very Common (>10%), Common (>1%), Uncommon (<1%) and Rare (<0.1%) Adverse event information.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female patients 18 to 65 years.
- •Patients uncontrolled on dual therapy (Glimepiride + Metformin) or (Sitagliptin + Metformin) with HbA1c more than 7.5 & less than 8.5 %.
- •Treatment-naïve with HbA1c more than 7.0 & less than 9.0%.
- •Patients with FBG more than 126 mg/dl & PPG more than 200 mg/dl.
- •Patients not taking any other OAD drugs.
排除标准
- •History of Type 1 diabetes.
- •Patients were treated with insulin within 8 weeks of screening.
- •Patients with renal dysfunction (crcl less than 60 ml/min) or proteinuria.
- •History of hypersensitivity.
- •Pregnant and lactating women.
- •Patients with Congestive Heart Failure, Unstable angina or ACS within past 6 months.
结局指标
主要结局
Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment.
时间窗: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
Mean change in FBG and 1 & 2-h PPG levels from baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
时间窗: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
Mean change in weight after 12 ± 1 weeks of treatment from baseline.
时间窗: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
Drug-Dose utilization pattern.
时间窗: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
次要结局
- Treatment adherence and compliance.(Safety assessment and tolerability.)
研究者
Dr Kunal Jhaveri
Vishesh Clinic of Internal Medicine