Signaling Mechanisms and Vascular Function in Diabetes Mellitus

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Ruboxistaurin is being tested to see if it is effective in treating certain diabetic complications, such as diseases of the blood vessels.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Eli Lilly and Company
• Treatments: Ruboxistaurin

Criteria

Inclusion Criteria:

• Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin

Exclusion Criteria:

• Any diabetic subject with a HgbA1C level of <7% or >11%

• Evidence of atherosclerosis

• symptoms of angina

• symptoms of claudication

• symptoms of cerebrovascular ischemia

• findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements

• hypertension defined as a systolic blood pressure > = 150 mmHg and a diastolic blood pressure >= 95 mmHg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics)

• hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and LDL cholesterol levels >130mg/dL.

• renal insufficiency (serum creatinine >1.5 mg/dL for men; >1.2 mg/dL for women)

• hepatic dysfunction defined as liver enzyme abnormalities > two times the upper limit of normal

• chronic pulmonary disease

• congestive heart failure

• pregnancy (or subjects planning to become pregnant);

• history of cigarette smoking within the last five years;

• history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)

• use of any, vasoactive, cardioactive, or non-steroidal anti-inflammatory medications within 24 hours of vascular testing visits