EUCTR2010-018580-42-HU进行中（未招募）1 期
Randomized, double-blind, placebo-controlled, parallel-group study of the safety and efficacy of imeglimin or placebo add-on therapy in type 2 diabetic subjects not adequately controlled by metformin monotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Poxel
- 入组人数
- 150
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
- All
入选标准
- •- Male or female type 2 diabetic subjects inadequately controlled by metformin monotherapy (1500 mg to 2000 mg per day, both inclusive) as defined by HbA1c = 7.5%
- •- Monotherapy with metformin stable for at least 10 weeks before randomization
- •- Age: = 18 to = 70 years
- •- Body Mass Index (BMI): = 20 to = 40 kg/m²
- •- HbA1c: = 7.5% and = 10%
- •- No treatment with any other oral anti-diabetic, including insulin within 3 months before randomization
- •- Creatinine clearance as estimated by the MDRD formula: = 80 mL/min/SSA (Standard Surface Unit = 1.73 m²)
- •- Permitted concomitant medication stable for at least 14 days before randomization
- •- Effective contraception for women of child bearing potential as defined by an accepted highly effective method of birth control with a low failure rate
- •- Subject has given written informed consent before any study-related activities are carried out
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any disease which in the investigator’s opinion would exclude the subject from the study
- •- Diagnosis of type 1 diabetes
- •- Acute condition which can impair renal function e.g. severe infectious disease or dehydration Uncontrolled high blood pressure (BP): diastolic = 100 mm Hg and systolic = 180 mm Hg
- •- History of drug- induced Torsade de Pointe or presence of a familial long QT syndrome
- •- Impairment of hepatic function (alkaline phosphatase [AP], aspartate aminotransferase [AST] or alanine aminotransferase [ALT] = 3 x the upper limit of normal)
- •- Pregnancy or lactation
- •- Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness
- •- Presence of a contraindication to the study medication or to metformin
- •- Known hypersensitivity to any of the constituents or excipients of the study drug or history with relevant drug (anaphylactic, anaphylactoid reactions)
- •- Evidence of retinopathy of severity =35 in the Classification of Retinopathy Severity (as defined by the Early Treatment Diabetic Retinopathy Study and outlined in Appendix II). An examination by an ophthalmologist within 12 months before randomization is strongly recommended
- •- Change in currently used medication and/or use of any new prescription or non-prescription medication within 14 days prior to randomization. The occasional use of paracetamol is not prohibited
- •- Positive screen for hepatitis B surface antigen (HbsAg), antibody to the hepatitis A virus (Anti-HAV
- •- Immunoglobulin M), antibody to the hepatitis C virus (Anti- HCV), or antibodies to human immunodeficiency (Anti- HIV) 1 and 2 virus
- •- Any history of alcohol abuse or drug addiction
- •- Smoking of more than 10 cigarettes, 3 cigars or 3 pipes per day
- •- Participation in a clinical study within 30 days before randomization
- •- Donation of blood within 30 days before randomization
研究者
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