Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes Mellitus, Hypertension, Carvedilol CR, Beta-blocker, Oxidative stress, Inflammation, Vascular benefits Read More

Inclusion Criteria:

• Is male or female >= 18 and <= 70 years of age
• Has a documented history of type 2 diabetes mellitus for a minimum of four months prior to the screening visit
• Has a documented history of or current presentation with Stage 1 or Stage 2 hypertension and meets one of the following criteria:
• Has controlled hypertension (sSBP <130 mmHg AND sDBP <80 mmHg) on >=2 antihypertensive medications NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications OR
• Has uncontrolled hypertension (sSBP >=130 and <=170 mmHg AND/OR sDBP >=80 and <=105 mmHg) on one or two antihypertensive medications OR
• Has newly diagnosed or previously untreated hypertension (sSBP >=130 and <=170 mmHg AND/OR sDBP >=80 and <=105 mmHg
• At Randomization, sitting systolic blood pressure (sSBP) >= 130 mmHg or sitting diastolic blood pressure (sDBP) >= 80 mmHg and sSBP <= 170 mmHg and sDBP <= 105 mmHg
• Has been on a stable dose of a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) for a minimum of four months prior to the screening visit

Exclusion Criteria:

• Has any clinically significant abnormality identified in the screening physical examination, laboratory tests or electrocardiogram which, in the judgement of the investigator, would preclude safe completion of the study
• Is female of childbearing potential
• Has any of these cardiac conditions: uncontrollable or symptomatic arrhythmias, unstable angina, sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker), bradycardia (heart rate <55 bpm), and stroke within three months of study screening, and history of myocardial infarction.
• Has Congestive Heart Failure NYHA (New York Heart Association) class II-IV
• Has type 1 diabetes mellitus
• Has newly diagnosed type 2 diabetes (within 4 months of screening visit)
• Has HbA1c > 8.5%
• Has the following, as it relates to subject's antidiabetic therapy:Initiated or changed dosage or formulation of thiazolidinediones (TZDs) within 6 months of screening visit.
• A history of acute or chronic acidosis, including diabetic ketoacidosis
• Has current clinical diagnosis of chronic obstructive pulmonary disease (COPD, e.g., chronic bronchitis) or asthma
• Has a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm
• Has evidence of any of the following clinically significant diseases that could impair the absorption, metabolism, or excretion of orally-administered medication:
• renal disease defined as estimated Glomerular Filtration Rate (eGFR) <60mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula below: GFR (mL/min/1.73m2) = 186 x [Serum Creatinine (umol/L) x 0.0113]-1.154 x Age(years)-0.203 (x 0.742 if female)
• hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical assessment)
• Chronic biliary disorders
• Has endocrine disorders (e.g., pheochromocytoma, active and untreated hypo or hyperthyroidism)
• Has any known contraindication to ACE inhibitors, alpha- or beta-blocker treatment
• Has systemic disease, including cancer, with reduced (<12 months) life expectancy
• Has used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
• Has a history of a psychological illness or any condition that would interfere with the subject's ability to understand or complete the requirements of the study