EUCTR2005-005702-23-DE进行中（未招募）不适用
Efficacy of 500µg roflumilast once daily versus placebo over 12 weeks in patients with diabetes mellitus type 2. A double blind, parallel group, phase IIb, proof of concept clinical study - FORTUNA
ycomed GmbH0 个研究点目标入组 190 人开始时间: 2006年8月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
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
- •· Given written informed consent
- •· Age > 35 and < or = 70 years
- •· Patients with diagnosis of type 2 diabetes according to ADA criteria (American Diabetic Association) and inadequately controlled on diet and exercise alone.
- •· HbA1c at baseline: > or = 7.5 – 8.5 %
- •· BMI between > or = 26 and < or =35 kg/m2
- •· Willingness of patient to check his/her blood glucose with equipment provided by the sponsor during the treatment phase in case of hypo- / hyperglycemia episodes
- •· Willingness to adhere to the physician’s advise to comply with diet and exercise
- •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
- •· Patients diagnosed with type-1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
- •· Patients diagnosed with a heamoglobinopathies, haemolytic anaemia or other diseases which interfere with HbA1c measurement
- •· Non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidysm
- •· Reported gain or loss of more than 5% of body weight within the last 2 month prior to V0
- •· Treatment with any diabetes medication prior to V0
- •· Treatment with any weight-loss medication within 3 months prior to V0
- •· Treatment with any not allowed medication or nutrition additives
- •· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
- •· Known infection with HIV, active hepatitis and/or active liver disease or unexplained elevations in ALT or AST (greater than 3X above the upper limit of normal for ALT or AST confirmed with repeat testing)
- •· History of clinically relevant diseases of the liver, kidney (including serum creatinine greater than 2.0 mg/dL) or gastrointestinal systems
- •· Diagnosis or history of cancer (other than basal cell carcinoma) within 5 years prior to study start
- •· Clinically significant cardial abnormalities (diagnosed clinically or by x-ray / ECG) that are not related to type 2 diabetes mellitus and that require further evaluation
- •· Diagnosis or history of stroke, myocardial infarct, chronic stable and unstable angina pectoris, ventricular arrhythmia, symptomatic congestive heart failure [NYHA III or IV) within 5 years prior to study start
- •· Uncontrolled hypertension, defined as blood pressure > 160/90 mmHg
- •· Presence or history of psychosis or psychotic disorders
- •· Suspected hypersensitivity to the study medication
- •· Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
- •· Female patients of childbearing potential (< 2 years postmenopausal or not sugically sterile), not using and not willing to continue using one of the following highly effective means of birth control with failure rates of less than 1% per year for > 30 days prior to enrollment, for the duration of the study, and for at least 30 days following the last dose of study medication:
- •- Combined oral contraceptives
- •- Approved implantable or injectable contraceptives
- •- Intrauterine contraceptives
- •In case none of the above mentioned contraceptive methods complying with the note for guidance CPMP/ICH/286/95 (modification) can be tolerated, the decision on an appropriate contraceptive method should be taken based on the expert advise of an obstetrician/gynecologist.
- •· Participation in another study (use of investigational product) within 30 days preceding the baseline visit V0 or re-entry of patients already enrolled in this trial.
- •· Participation in a clinical study with study medication for weight loss or type 2 diabetes
- •· Suspected inability or unwillingness to comply with study procedures
- •· History or presence of alcohol or drug dependence within 7 years prior to Screening
- •· Inability to follow study procedures due to e.g. language problems
研究者
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