NCT02029846终止4 期
Glycemia in Diabetic Elders Trial
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
- 2
- 试验地点
- 1
- 主要终点
- Time to Achieve Glycemic Target (HbA1c <7.5%).
研究概览
简要总结
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetics diagnosed for at least 6 months
- •Patients ages ≥ 65 years and older
- •Active patients in the Bay West Endocrinology practice
- •Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
- •Eligible for randomization to either treatment group
- •Patients willing to follow either treatment arm including regimen using one or more injectables
- •Patients to have an English Reading Level of Grade 6 or above
- •Patients residing at home
排除标准
- •Unwilling to use a regimen that may contain using one or more injections
- •Using short acting insulin prior to the study
- •Using GLP-1 in past 10 weeks
- •History of hypoglycemia unawareness or episodes needing emergency intervention
- •End-stage renal disease
- •Blindness
- •Terminal illness
研究组 & 干预措施
Standard Treatment
Active Comparator
A regimen with traditional drugs only
干预措施: Standard Treatment (Drug)
Incretin-based Treatment
Experimental
A regimen including incretin-based drugs
干预措施: Incretin-Based Treatment (Drug)
结局指标
主要结局
Time to Achieve Glycemic Target (HbA1c <7.5%).
时间窗: 6 months
Data not analyzed due to n=1 each arm.
次要结局
- Overall Hypoglycemia Measured by Glucose Meter(6 months)
研究者
研究点 (1)
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