NCT01006018终止不适用
DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Insulin Secretion
研究概览
简要总结
To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Impaired glucose tolerance (IGT) by oral glucose tolerance test
排除标准
- •History of diabetes mellitus
- •History of congestive heart failure
- •History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
- •History of liver disease (ALT or AST >2.5 times the upper limit of normals)
- •History of renal disease (serum creatinine >1.5 mg/dl)
- •History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)
- •Current treatment with glucocorticoids
- •History of immune disorder, including HIV
- •Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures
研究组 & 干预措施
Sitagliptin + Pioglitazone PLACEBO
Experimental
Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
- pioglitazone PLACEBO daily by mouth
干预措施: Sitagliptin + Pioglitazone PLACEBO (Drug)
Sitagliptin + Pioglitazone
Experimental
Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
- pioglitazone (TZD) 15 mg daily by mouth
干预措施: Sitagliptin + Pioglitazone (Drug)
PLACEBO
Placebo Comparator
Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
- pioglitazone (TZD) PLACEBO daily by mouth
干预措施: PLACEBO (Drug)
结局指标
主要结局
Insulin Secretion
时间窗: baseline, 6 months, 9 months (after a 3 month washout)
Not measured as study was prematurely terminated due to unanticipated delays.
次要结局
未报告次要终点
研究者
Dr. Mary Rhee
Assistant Professor
Emory University
研究点 (2)
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