NCT01527747暂停4 期
Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in fasting and postprandial triglyceride concentrations
研究概览
简要总结
The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on fasting and post-meal blood triglyceride (blood fat) levels.
详细描述
This study is designed to help us understand the effects of DPP-4 inhibition on triglyceride levels before and after eating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Willing to provide signed written informed consent
- •Men and women aged 18-80 years
- •Type 2 diabetes (as defined by the ADA - see reference 18)
- •Baseline HgbA1c between 6.5% and 8%; HgbA1c 7.5-8.0% among subjects taking sulfonylureas
- •Baseline plasma triglyceride concentration between 200 and 700 mg/dl
- •Stable diabetes medication regimen for at least 12 weeks prior to study entry
- •Taking a statin for at least 8 weeks, unless statin therapy is contraindicated or intolerable
- •Treatment with other lipid-lowering medications only if the dose has been stable for > 8 weeks.
- •Non-smoker
- •Body mass index < 45.0 kg/m2
- •BP < 140/85
- •Normal serum TSH and free T4 concentrations (hypothyroid subjects taking a stable replacement dose of levothyroxine will be allowed if they are biochemically euthyroid)
- •Subjects will otherwise be healthy
- •Women of child-bearing potential must be willing to use reliable contraception, as defined by our IRB, throughout the study (There are currently no FDA recommended restrictions on the use of saxagliptin in sexually active men, or requirements for contraception in their wives or sexual partners)
- •Able and willing to complete study procedures
排除标准
- •Transaminase concentrations > 2 times the ULN. (Mild elevations of AST and ALT will be allowed up to 2x ULN at baseline if there is no evidence of viral hepatitis or intrinsic liver disease. Since many of these subjects may have some degree of hepatic steatosis, a key intervention is the implementation of treatment to lower glucose and triglycerides)
- •Estimated creatinine clearance < 60 ml/min
- •Microalbumin-creatinine ratio > 120
- •Alcohol consumption > 1 drink daily in women and > 2 drinks daily in men
- •Pancreatitis within the preceding 6 months
- •Type 1 diabetes
- •History of diabetic ketoacidosis (DKA)
- •Cardiovascular disease (CAD, stroke, PVD)
- •Known human immunodeficiency virus (HIV) infection
- •Viral hepatitis
- •Pregnancy or lactation
- •A current diagnosis of active non-dermatologic cancer
- •Other life-threatening illness
- •History of small bowel resection or gastric bypass surgery
- •Use of glucocorticoid medications, beta blockers, thiazide diuretics, excess alcohol intake (beta-blockers and thiazide diuretic will be allowed, if necessary, if the dose has been stable for > 12 weeks prior to study entry and the dose will remain stable throughout the study. Complete exclusion of these drugs would exclude a substantial proportion of diabetic patients)
- •Use of systemic cytochrome P450 3A4 (CYP 3A4/5) inhibitors such as ketaconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.
- •Current enrollment in another research study or use of any investigational drug within 90 days of study entry
- •Other medical conditions that may interfere with participation in the study, in the opinion of the investigator
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo arm
干预措施: Saxagliptin (Drug)
Saxagliptin
Experimental
Active drug arm
干预措施: Saxagliptin (Drug)
结局指标
主要结局
Change in fasting and postprandial triglyceride concentrations
时间窗: baseline, 6 weeks
Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin
次要结局
- Changes in glycemia(baseline, 6 weeks)
研究者
P. Barton Duell, M.D.
Director, Lipid-Atherosclerosis Laboratory
Oregon Health and Science University
研究点 (1)
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