Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease

Completed · Phase 2

Conditions studied: Diabetes, Coronary Artery Disease

In brief

ALT-2074 (BXT-51072) belongs to a class of drugs called "glutathione peroxidase mimics." ALT-2074 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2 genotype have poor cardiovascular clinical outcomes. The purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype

Key facts

Study ID

NCT00491543

Run by

Synvista Therapeutics, Inc

People needed

66

Starts

2007-06-01

Expected to finish

2008-05-01

Last updated by the study team

2008-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 to 75 years of age.
• Diagnosis of Type 2 diabetes mellitus
• Stable coronary artery disease (CAD) documented or suspected, not requiring adjustment for ≥2 months, as determined by: a. A history of myocardial infarction verified by Q-wave electrocardiogram and/or medical records, occurring greater than 6 months before the screening Visit; OR b. A coronary angiogram and/or stress test; OR c. A ankle brachial pressure index less than 0.9; OR d. Age greater than 60 years of age
• Hp 2-2 genotype.
• Ability to communicate and comply with all study requirements.

Where it is running

• Radiant Research — Chicago, Illinois, United States
• Radiant Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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