NCT00651105已完成3 期
A Double-blind, Placebo-controlled, Randomized, Cross-over Study to Evaluate the GLP-1-mediated and Non-GLP-1-mediated Effects of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
适应症
干预措施
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
- 63
- 试验地点
- 1
- 主要终点
- GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects
研究概览
简要总结
The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon secretion, using treatment observations of the overall glycemic response.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria - Type-2 Diabetes Patients
- •Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and who are in otherwise good health
- •Must have been diagnosed with T2DM at least 6 months prior to screening, and whose diabetes is controlled by diet and exercise alone or by stable dosage ( > 3 months) of metformin
- •HbA1c in the range of 6.5% to 9% at screening
- •Inclusion Criteria - Healthy Volunteers
- •Male or female subjects aged 30 to 75 years, determined to be in good health
- •Normal oral glucose tolerance test (OGTT) at screening
- •Age, gender and weight matched to subjects with T2DM
排除标准
- •Exclusion criteria - Type-2 Diabetes Patients
- •A history of:
- •Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly
- •Acute metabolic diabetic complications (such as ketoacidosis or hyperosmolar state (coma)) within the past 6 months
- •Torsades de Pointes, ventricular tachycardia or ventricular fibrillation
- •Any severe hypoglycemic episode within 3 months of screening
- •Use of any of the following medications:
- •Antihypertensive or lipid-lowering agents unless on a stable dose for at least 3 months prior to screening
- •Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
- •Chronic oral/intramuscular/intravenous corticosteroid treatment ( > 7 consecutive days of treatment) within 8 weeks prior to screening
- •Exclusion Criteria - Healthy Volunteers
- •First degree relative of an individual with T2DM
- •History of gestational diabetes
- •Use of any prescription medication within 1 month prior to dosing. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: Vildagliptin (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects
时间窗: from baseline to Day 10
次要结局
- Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.(10 day treatment periods)
研究者
研究点 (1)
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