Effect of Dosage Reduction of Glucose-Lowering Multidrug Regimens on the Incidence of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: An Open-Label, Parallel-Group, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 687
- 试验地点
- 1
- 主要终点
- Hyperglycemia
研究概览
简要总结
Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Our aim is to investigate the effect of dosage reduction of four glucose-lowering multidrug regimens on the incidence of acute glycemic complications in people with type 2 diabetes who fast during Ramadan.
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
- •Prospective participant is a returning patient with type 2 diabetes;
- •Prospective participant expressed an intention to fast during Ramadan;
- •Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.
排除标准
- •Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;
- •Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;
- •Prospective participant has received niacin or corticosteroids within one month; and,
- •Prospective participant has any history of recurrent hypoglycemia, hypoglycemia unawareness, chronic renal insufficiency (stages IV or V), liver cirrhosis, uncontrolled epilepsy, depressive disorder, bipolar disorder, psychotic disorder, or cognitive dysfunction.
研究组 & 干预措施
Low-dosage therapy
干预措施: Metformin and Glimepiride (Low Dosage) (Drug)
Low-dosage therapy
干预措施: Metformin and Vildagliptin (Low Dosage) (Drug)
Low-dosage therapy
干预措施: Metformin and Insulin Glargine U100 (Low Dosage) (Drug)
Low-dosage therapy
干预措施: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage) (Drug)
Regular-dosage therapy
干预措施: Metformin and Glimepiride (Regular Dosage) (Drug)
Regular-dosage therapy
干预措施: Metformin and Vildagliptin (Regular Dosage) (Drug)
Regular-dosage therapy
干预措施: Metformin and Insulin Glargine U100 (Regular Dosage) (Drug)
Regular-dosage therapy
干预措施: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage) (Drug)
结局指标
主要结局
Hyperglycemia
时间窗: 29 days of Ramadan
Incidence of hyperglycemia
Hypoglycemia
时间窗: 29 days of Ramadan
Incidence of hypoglycemia
次要结局
- Diabetic ketoacidosis(29 days of Ramadan)
- Hyperosmolar hyperglycemic state(29 days of Ramadan)
研究者
Ayman A. Zayed, MD
Professor of Medicine
University of Jordan