NL-OMON36735招募中2 期
A Phase 2A, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male patients with increased Cardiometabolic Risk - The Torrent study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult male
- •2. Age range 30-65 years at screening
- •3. Caucasian or Indian Ethnicity
- •4. Waist circumference * 102 cm for Caucasians and * 90 cm for Indians at screening.27
- •5. Fasting Serum Insulin * 10 mU/ml at screening
- •6. Blood Pressure 130/85 mmHg at screening(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 naïve diabetic patients* or patients with impaired fasting glucose i.e > 100 mg/dl or 5.5 mmol/l and < 200 mg/dl or 11.0 mmol/l. 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
排除标准
- •1. Medical history, physical examination, vital signs, clinical laboratory tests, 12-lead ECG and Chest X ray (in India only) with any significant abnormalities, in the opinion of the investigator.
- •2. Subjects with any known somatic illness
- •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 < 60 mL/min/1.73m2 at screening
- •5. History of angina, Myocardial Infarction (MI) or stroke since last 6 months.
- •6. Hypertension with SBP/DBP *160/100 mm Hg at screening.
- •7. ALT or AST * ULN*3 at screening
- •8. Heavy smokers (who are smoking >15 cigarettes or equivalent per day).
研究者
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