Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Diabetes Quality of Life assessment using DQOL-13 questionnaire
研究概览
简要总结
Scarcity of local patients' quality of life data assessing diabetes treatment led us design a protocol to assess improvement in the quality of life of patients with Type II Diabetes mellitus. Quality of life measures are designed to enable patients' perspectives on the impact of health & healthcare interventions on their lives to be assessed & taken into account in clinical decision making & research. Its an open label experimental study where participants are assessed for quality of life impact over 6 months duration on Metformin + Sitagliptin therapy. Their safety and efficacy profiles will also be monitored
详细描述
Study Objective: To assess the changes in quality of life (QOL) in patients with type 2 diabetes mellitus receiving sitagliptin plus metformin therapy in routine care.
Study design: Open label, prospective, multicenter, experimental study.
Sample size: The sample size is 157. To overcome loss to follow-ups, total n=300 will be recruited where each site will enroll 30 patients.
Number of Site: There will be 10 sites.
Duration of study: 12 months (data lock point will be the completion of 6 months of follow-up from the time of last patient's enrollment date)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with Type 2 Diabetes mellitus between 18 to 65 years
- •HbA1C 7% - 10%
- •who can give informed consent.
- •Patient uncontrolled on metformin and lifestyle modification from at least 3 months or who are metformin resistant
排除标准
- •type 1 diabetes
- •≥1 episode of Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state,
- •≥1 episode of severe hypoglycaemia,
- •Pregnant or lactating women,
- •Pancreatitis,
- •any serious complications or hypersensitivity
研究组 & 干预措施
Uncontrolled Diabetes with Metformin or Metformin resistant
干预措施: Metformin / Sitagliptin Oral Tablet (Drug)
结局指标
主要结局
Diabetes Quality of Life assessment using DQOL-13 questionnaire
时间窗: 6 months
Satisfaction (6 questions) Impact (4 questions) Worry (3 questions) Scoring from 1 to 5 for worst to best quality at each question (low score means poor quality) Assessment at enrollment and follow ups (at 1st, 3rd and 6th months)
次要结局
- Frequency of adverse events and serious adverse events during the course of study follow-up(6 months)
- Change from baseline in HbA1c % and fasting blood sugar FBS (mg/dl) to the last-observation on treatment(6 months)