NCT00380380已完成3 期
A Randomized, Single-blind, Placebo Controlled, Cross-over Study to Evaluate the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Evaluate the effects of acute effects of vildagliptin on gastric emptying
研究概览
简要总结
Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to complete a 1-week wash-out of current anti-diabetic medications
- •Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
- •Blood glucose criteria must be met
排除标准
- •History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- •Need for insulin within 3 months or patients on thiazolidinediones
- •Significant concommitant disease or complications of diabetes
- •Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
- •Abnormal liver function tests as defined by the protocol
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Evaluate the effects of acute effects of vildagliptin on gastric emptying
次要结局
- Effect on steady state levels of active GLP-1 and GIP
- Change in fasting and postprandial glucose levels.
- Change in glucagon secretion
- Effect on gastric peristalsis
- Effect on satiety
- Change in postprandial glucose kinetics
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical EffectsInflammationPsoriasisNCT01261767Novo Nordisk A/S55
已完成
1 期
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)InflammationSystemic Lupus Erythematosus (SLE)NCT00960362Argos Therapeutics13
终止
1 期
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy VolunteersMetabolism and Nutrition DisorderObesityNCT01044108Novo Nordisk A/S117
已完成
1 期
A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 YearsMetabolism and Nutrition DisorderObesityNCT02696148Novo Nordisk A/S24
撤回
2 期
Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 InfectionCOVID-19NCT05074394Sorrento Therapeutics, Inc.