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
- 3 期
- 状态
- 已完成
- 入组人数
- 870
- 主要终点
- Percentage of Participants With at Least One Symptomatic Hypoglycemic Event
研究概览
简要总结
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.
详细描述
This study and NCT01131182 (MK-0431-263) 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, with type 2 diabetes mellitus
- •Intends to fast during the month of Ramadan
- •Hemoglobin A1c (HbA1c) ≤10% at screening
- •On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose
排除标准
- •Type 1 diabetes mellitus
- •Pregnant or breast feeding or with gestational diabetes
- •Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
- •Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
- •History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
- •Any use of insulin (prior to or during Ramadan)
- •Use of any class of oral antidiabetic therapy other than an SU or metformin
- •Current participation in another interventional study
研究组 & 干预措施
Sitagliptin
Sitagliptin 100mg taken orally once daily with or without metformin
干预措施: Sitagliptin (Drug)
Sitagliptin
Sitagliptin 100mg taken orally once daily with or without metformin
干预措施: Metformin (Drug)
Sulfonylurea Therapy
Usual sulfonylurea therapy with or without metformin
干预措施: Sulfonylurea (Drug)
Sulfonylurea Therapy
Usual sulfonylurea therapy with or without metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Symptomatic Hypoglycemic Event
时间窗: Up to 30 days (Day 1 through last day of Ramadan)
Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).
次要结局
- Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event(Up to 30 days (Day 1 through last day of Ramadan))