An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,147
- 主要终点
- Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
研究概览
简要总结
This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.
详细描述
This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
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
- •Muslim men and women with type 2 diabetes
- •Participants who intend to fast during the month of Ramadan
- •Participants who have been on a stable dose of sulfonylurea for at least three months
排除标准
- •Participants with type 1 diabetes mellitus
- •Pregnant or breast feeding women
- •Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
- •Participants on insulin
- •Participants on any class of oral diabetic therapy other than sulfonylurea or metformin
研究组 & 干预措施
Sitagliptin
Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
干预措施: Sitagliptin phosphate (Drug)
Sitagliptin
Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
干预措施: Metformin (Drug)
Sulfonylurea
Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
干预措施: Metformin (Drug)
结局指标
主要结局
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
时间窗: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
次要结局
- Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event(30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10))