EUCTR2011-002986-39-DE进行中（未招募）不适用
A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Fourfold Cross-Over Study to Investigate the Glucose Lowering Effects of Dextromethorphan and Amantadine in Subjects with Type 2 Diabetes Mellitus (T2DM) after an Oral Glucose Tolerance Test
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Male with T2DM on a stable regimen of metformin monotherapy, between 45 and 70 years of age, with a BMI between 25 and 35 kg/m2, HbA1c between 6.5 and 8% (extremes included).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
- •Male with T2DM on a stable regimen of metformin monotherapy, between 45 and 70 years of age, with a BMI between 25 and 35 kg/m2, HbA1c between 6.5 and 8% (extremes included).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
- •- Current or previous treatment with insulin therapy
- •- Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening
- •- Any severe medical or surgical history of conditions likely to confound study assessments or study endpoints
- •- Serious respiratory, serious and/or unstable coronary heart disease, congestive heart failure of New York Heart Association Class II or worse, second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of stroke (within the preceding 6 months) or serious peripheral vascular disease
- •- History of arrhythmia that is symptomatic or requires treatment
- •- Marked diabetic complications
- •- Any respiratory disease leading to respiratory insufficiency and/or depression
- •- Clinically significant vital signs or 12-lead ECG findings
- •- Clinical or laboratory evidence of hepatic dysfunction or disease
- •- Moderate or severe renal dysfunction defined as a calculated GFR <70 ml/min
- •- Uncontrolled high blood pressure
- •- History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
- •- Use of concomitant medication which would confound study conduct
- •- Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
- •- Current or previous treatment with insulin therapy
- •- Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening
- •- Any severe medical or surgical history of conditions likely to confound study assessments or study endpoints
- •- Serious respiratory, serious and/or unstable coronary heart disease, congestive heart failure of New York Heart Association Class II or worse, second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of stroke (within the preceding 6 months) or serious peripheral vascular disease
- •- History of arrhythmia that is symptomatic or requires treatment
- •- Marked diabetic complications
- •- Any respiratory disease leading to respiratory insufficiency and/or depression
- •- Clinically significant vital signs or 12-lead ECG findings
- •- Clinical or laboratory evidence of hepatic dysfunction or disease
- •- Moderate or severe renal dysfunction defined as a calculated GFR <70 ml/min
- •- Uncontrolled high blood pressure
- •- History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
- •- Use of concomitant medication which would confound study conduct
研究者
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