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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 主要终点
- Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
研究概览
简要总结
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.
详细描述
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo QD
干预措施: Placebo (Drug)
Alogliptin 25 mg QD
干预措施: Alogliptin (Drug)
Alogliptin 25 mg QD + Pioglitazone 30 mg QD
干预措施: Alogliptin and Pioglitazone (Drug)
结局指标
主要结局
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
时间窗: 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.
次要结局
- Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)(Baseline, Week 4 and Week 16.)
- Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.(Baseline and Week 4.)
- Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.(Baseline, Week 4 and Week 16.)
- Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.(Baseline, Week 4 and Week 16.)
- Postprandial Changes Over Time From Baseline for Glucose(Baseline, Week 4 and Week 16.)
- Postprandial Changes Over Time From Baseline for Insulin(Baseline, Week 4 and Week 16.)
- Postprandial Changes Over Time From Baseline for Glucagon(Baseline, Week 4 and Week 16.)
- Change From Baseline in Glycosylated Hemoglobin(Baseline, Week 8 and Week 16.)
- Change From Baseline in Fasting Plasma Glucose(Baseline, Week 4, Week 8 and Week 16.)
- Change From Baseline in Postprandial C-Peptide(Baseline, Week 4 and Week 16.)
- Change From Baseline in Postprandial Proinsulin(Baseline, Week 4 and Week 16.)
- Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)(Baseline, Week 4 and Week 16.)
- Change From Baseline in Adiponectin(Baseline, Week 4 and Week 16.)
- Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)(Baseline, Week 4 and Week 16.)
- Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)(Baseline, Week 4 and Week 16.)
- Change From Baseline in e-Selectin(Baseline, Week 4 and Week 16.)
- Change From Baseline in Endothelial Function Through Pulse Wave Tonometry(Baseline and Week 16.)