CTRI/2013/03/003470已完成1 期
A Phase 2A Double blind Placebo controlled RandomizedStudy to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male patients with increased Cardiometabolic Risk
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects will be considered eligible for entry in the study if they meet all of the following criteria
- •1 Adult male
- •2 Age range 30 to 65 years
- •3 Caucasian or Indian ethnicity
- •4 Waist circumference greater than equal to 102 cm for Caucasians and greater than equal to 90 cm for Indians at screening
- •5 Fasting serum insulin greater than equal to 10 mU per ml at screening
- •6 Blood Pressure greater than equal to 130 bar 85 mmHg or patients taking medication for hypertension
- •7 Stable weight during 3 months prior to the study assessed through medical history of the patient
- •8 Drug naive diabetic patients or patients with impaired fasting glucose greater than 100 mg per dl and less than 200 mg per dl. Diabetic patients who were taking metformin and have undergone washout for at least 4 weeks before Day 0 and are currently on life style modification as a treatment for diabetes will also be allowed in the study
- •9 Willingness to give written informed consent prior to any study-related procedures being performed and ability to adhere to the study restrictions and assessments schedule
排除标准
- •Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.
- •1 Medical history physical examination vital signs clinical laboratory tests 12 lead ECG and Chest X ray to exclude tuberculosis in India only with any significant abnormalities in the opinion of the investigator
- •2 Subjects with any known somatic illness including neoplasm endocrine disorder such as cushings disease PCOD and uncontrolled hypothyroidism neurologic disorder active infection or recent surgical procedure within 3 months of the study initiation
- •3 Subject currently using medication which can influence glucose or FFA metabolism such as fibrates niacin ACE inhibitors PPAR agonists omega 3 fatty acids
- •4 eGFR less than 60 mL per min per 1.73m2 as evaluated by Modification of Diet in Renal Disease MDRD method
- •5 History of angina Myocardial Infarction MI or stroke since last 6 months
- •6 Hypertension with SBP and DBP greater than equal to 160 bar 100 mmHg.
- •7 ALT or AST greater than equal to 3 times ULN
- •8 History or presence of malignancy
- •9 History of recreational drug use within the last 30 days or regular consumption of greater than 2 units of alcohol per day
- •10 History of allergy to the test drug or any drug chemically similar to the drug under investigation
- •11 Positive for urine drugs of abuse test at screening
- •12 Seropositive for Hepatitis B Hepatitis C or HIV
- •13 Subjects suffering from any psychiatric acute or chronic illness
- •14 Intake of any medication except those permitted in this study
- •15 Intake of any investigational drug in the period within 3 months prior to the first dose of study drug
- •16 History of significant blood loss due to any reason including blood donation, in the 12 weeks prior to the first dose of study drug or the total blood loss in the last 3 months, including for this study exceeds 450 mL
- •17 History of any bleeding disorder
- •18 Existence of any surgical or medical condition which in the judgment of the principal investigator might interfere with the absorption distribution metabolism or excretion of the study drug or might be likely to compromise the safety of the subject
- •19 Inability to communicate or cooperate with the investigator because of language problems poor mental development or impaired cerebral function
- •20 Inability to comply with study requirements
- •21 Positive drugs of abuse test and alcohol breath test
- •22 Heavy smokers who are smoking greater than 15 cigarettes or equivalent per day
研究者
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