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

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•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

•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

Not specified