NCT00766441终止4 期
Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Occurrence of hypoglycemia
研究概览
简要总结
This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.
详细描述
To define metabolic alterations during Ramadan:
- Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values.
- Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c)/Fructosamine, triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C).
- A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Muslim men and women with Type 2 diabetes.
- •Age 18-78 years
- •Intending to fast during the month of Ramadan
- •On oral antihyperglycemic agents (sulphonylurea based/combination therapy)
排除标准
- •Patient with hypersensitivity or contraindication to Sitagliptin treatment
- •Patient with CKD (creatinine clearance <50 ml/min)
- •Patients who have participated in another intervention study in the last 2 months
- •Patients who do not give informed consent
- •Pregnant or breast feeding women.
- •Patients on insulin
- •Patients with severe liver disease
研究组 & 干预措施
1
Active Comparator
Sitagliptin 100mg
干预措施: Sitagliptin (Drug)
2
Active Comparator
Sulphonylurea
干预措施: sulphonylurea (Drug)
结局指标
主要结局
Occurrence of hypoglycemia
时间窗: 4 weeks during Ramadan
次要结局
- Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions(4 weeks during Ramadan)
研究者
研究点 (1)
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