RESEARCH STUDY SUMMARY:
A Phase 3 clinical study of ORAL DRUG X for patients with Type 2 Diabetes Mellitus with established vascular disease in the coronary ,cerebral or peripheral arteries.
PURPOSE:
This study will evaluate the efficacy and safety of ORAL DRUG X in participants with type 2 diabetes mellitus with established vascular disease in the coronary, cerebral or peripheral arteries.
- Study Type: Interventional
- Overall Recruitment Status: Recruiting
- Study Start Date: JUNE 2016
- Estimated Study Completion Date: JUNE 2021
- Estimated Primary Completion Date: JULY 2021(Final data collection date for primary outcome measure)
Inclusion Criteria:
- Male or Female subjects > 40 yrs of age with a Diagnosis of T2DM
- HbA1c at screening visit of 7.0-10.5 % on stable allowable anti –hyperglycemic agents or on no background AHA for at least 8 weeks prior to the screening visit
- Evidence or a history of atherosclerosis involving the coronary ,cerebral or peripheral vascular systems (Coronary artery disease –Myocardial infarction ,history of coronary revascularization ,PCI,CABG,Ischaemic stroke,carotid revascularization,Peripheral arterial disease,Subjects with multiple cardiovascular qualifying events are also eligible for enrollment)
Exclusion Criteria:
- Sitting systolic blood pressure >160 mmHg and /or Diastolic blood pressure > 90 mm Hg at the screening visit
- Fasting triglycerides >600 mg/dl at the screening visit
- Fasting plasma or finger stick glucose >270 mg/dl
- Heart Failure –Class IV ,NYHA classification
- Hemoglobin <10g/dl
- STSH, outside the reference range
- Active, obstructive uropathy or indwelling urinary catheter.
