Early Diabetes Intervention Program
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Progression of fasting glucose >140 mg/dL
研究概览
简要总结
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
详细描述
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting plasma glucose <140 mg/dL
- •75 g OGTT 2hr glucose >120 mg/dL
- •BMI > 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes
- •Age at least 25 years
排除标准
- •Cancer within 5 years
- •Chronic infectious disease (HIV, Hepatitis)
- •CVD event within 6 months
- •Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control
- •elevated AST or ALT
- •Serum creatinine >1.4 mg/dL (men) or >1.3 mg/dL (women)
- •TG >600 mg/dL
- •Known glucosidase intolerance
- •Inability to comply with protocol requirements.
研究组 & 干预措施
Placebo
Matched placebo was administered for acarbose 100 mg once daily
干预措施: Placebo (Drug)
Acarbose
acarbose 100 mg once daily
干预措施: Acarbose (Drug)
结局指标
主要结局
Progression of fasting glucose >140 mg/dL
时间窗: From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization
Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression.
次要结局
未报告次要终点
研究者
Kieren Mather
Associate Professor of Medicine
Indiana University