Effect of LY333531 on Vascular and Neural Functions

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.

Key facts

Study ID

NCT00482976

Run by

Chromaderm, Inc.

People needed

30

Starts

2003-12-01

Expected to finish

2005-03-01

Last updated by the study team

2016-07-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1
• HbA1c less than 9% and fasting plasma glucose less than 260mg/dl
• Blood pressure less than 160/100 mmHg
• Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl

You may not qualify if…

• Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit 1.
• History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure.
• Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control)
• TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease.
• ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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