TART - Troglitazone Atherosclerosis Regression Trial

• Status: Completed
• Trial end date: 2000-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parke-Davis
• Treatments: Troglitazone

Criteria

Inclusion Criteria:

• Men and women ages 30-70 years

• Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions

• At least 30 years of age at onset of diabetes

• Metabolic control and management requiring insulin without other anti-diabetic medications

• Willingness to sign informed consent

Exclusion Criteria:

• Known sensitivity to troglitazone or other thiazolidinediones

• For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial

• Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization

• Medical illness that may require oral or parenteral glucocorticoid therapy

• Physical disability that would interfere with diabetes self-management

• Untreated or unstable diabetic retinopathy

• History of insulin allergy

• Present or recent history of alcohol intake over 5 drinks per day or substance abuse

• Participation in another clinical trial

• Currently taking nicotinic acid