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Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

2013年5月23日 更新者：Takeda

Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes

The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

研究概览

地位

完全的

条件

干预/治疗

详细说明

SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.

This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.

研究类型

介入性

注册 (实际的)

71

阶段

  • 第三阶段

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

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 70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

  • Diagnosis of type 2 diabetes
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
  • Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
  • Fasting plasma glucose less than 13.3 mmol per L.
  • Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
  • Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
  • Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
  • If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
  • Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.

Exclusion Criteria

  • History of type 1 diabetes.
  • History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
  • Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
  • History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
  • Hemoglobin less than 120 g per L for males and less than100 g per L for females.
  • Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  • Serum creatinine level greater than 133 μmol per L.
  • Fasting total cholesterol greater than 6.5 mmol per L.
  • New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
  • History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
  • History of acute metabolic diabetic complications.
  • History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
  • History of infection with human immunodeficiency virus.
  • History of diabetic gastro paresis.
  • History of gastric bypass surgery.

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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂 QD
药品：Placebo
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
其他名称：
  • 阿托斯
  • SYR-322
  • AD-4833
实验性的：阿格列汀 25 毫克 QD
药品：Alogliptin
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
其他名称：
  • SYR-322
  • SYR110322
实验性的：Alogliptin 25 mg QD + Pioglitazone 30 mg QD
药品：Alogliptin and Pioglitazone
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
其他名称：
  • 阿托斯
  • SYR-322
  • SYR110322
  • AD-4833
  • 阿格列汀

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
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
大体时间：Baseline and Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Baseline and Week 16.

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
大体时间：Baseline and Week 4.
The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.
Baseline and Week 4.
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
大体时间：Baseline, Week 4 and Week 16.
The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
大体时间：Baseline, Week 4 and Week 16.
Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
大体时间：Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucose
大体时间：Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Insulin
大体时间：Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon
大体时间：Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Glycosylated Hemoglobin
大体时间：Baseline, Week 8 and Week 16.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.
Baseline, Week 8 and Week 16.
Change From Baseline in Fasting Plasma Glucose
大体时间：Baseline, Week 4, Week 8 and Week 16.
The change in fasting plasma glucose collected at each week indicated relative to baseline.
Baseline, Week 4, Week 8 and Week 16.
Change From Baseline in Postprandial C-Peptide
大体时间：Baseline, Week 4 and Week 16.
The change in postprandial C-peptide collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Proinsulin
大体时间：Baseline, Week 4 and Week 16.
The change in postprandial proinsulin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
大体时间：Baseline, Week 4 and Week 16.
The change in hs-CRP collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Adiponectin
大体时间：Baseline, Week 4 and Week 16.
The change in adiponectin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
大体时间：Baseline, Week 4 and Week 16.
The change in VCAM collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
大体时间：Baseline, Week 4 and Week 16.
The change in ICAM collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in e-Selectin
大体时间：Baseline, Week 4 and Week 16.
The change in e-Selectin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
大体时间：Baseline and Week 16.
Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.
Baseline and Week 16.

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。

赞助

Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2007年7月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2008年4月4日

首先提交符合 QC 标准的

2008年4月9日

首次发布 (估计)

2008年4月10日

研究记录更新

最后更新发布 (估计)

2013年5月27日

上次提交的符合 QC 标准的更新

2013年5月23日

最后验证

2013年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SYR-322_301
  • 2007-000486-38 (EudraCT编号)
  • U1111-1113-2081 (注册表标识符：WHO)
  • NL22649.029.08 (注册表标识符：CCMO)

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.

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