Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
2015年1月22日 更新者：Novartis Pharmaceuticals
A Randomized, Double-blinded, Placebo-controlled, Crossover Trial to Assess the Effect of Orally Administered LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).
研究概览
研究类型
介入性
注册 (实际的)
14
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Chula Vista、California、美国、91910
- Novartis Investigative Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients, age 18-65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
- Fasting plasma glucose ≤250mg/dL at screening.
- If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
Exclusion Criteria:
- Patients with type 1 diabetes mellitus.
- Patients with history of acute diabetic complications within the 6 months prior to screening.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
- Patients with signs or symptoms of significant diabetic complications.
- Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
Other protocol-defined inclusion/exclusion criteria may apply
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg
Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days.
Period 2- Placebo treatment once daily for 4 days Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days.
Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days.
14 days washout periods between treatment periods.
|
LIK066 15 mg, 50 mg and 150 mg
|
|
实验性的：Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo
Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days.
Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days.
Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days.
Period 4- Placebo treatment once daily for 4 days.
14 days washout periods between treatment periods.
|
LIK066 15 mg, 50 mg and 150 mg
|
|
实验性的：Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg
Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days.
Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days.
Period 3- Placebo treatment once daily for 4 days.
Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days.
14 days washout periods between treatment periods.
|
LIK066 15 mg, 50 mg and 150 mg
|
|
实验性的：Sequence 3: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg
Period 1- Placebo treatment once daily (q.d.) for 4 days.
Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days.
Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days.
Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days.
14 days washout periods between treatment periods.
|
LIK066 15 mg, 50 mg and 150 mg
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose
大体时间：Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)
|
Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations.
The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule.
The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.
|
Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年7月1日
初级完成 (实际的)
2014年1月1日
研究完成 (实际的)
2014年1月1日
研究注册日期
首次提交
2013年8月1日
首先提交符合 QC 标准的
2013年8月1日
首次发布 (估计)
2013年8月5日
研究记录更新
最后更新发布 (估计)
2015年2月6日
上次提交的符合 QC 标准的更新
2015年1月22日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.