Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease
A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ALT 2074 in Subjects With Type 2 Diabetes Who Have a Haptoglobin Type 2-2 Genotype and Coronary Artery Disease
1 other identifier
interventional
66
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes
Started Jun 2007
Shorter than P25 for phase_2 diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2007
CompletedFirst Posted
Study publicly available on registry
June 26, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedJuly 2, 2008
June 1, 2007
June 23, 2007
July 1, 2008
Conditions
Outcome Measures
Primary Outcomes (3)
Biomarkers of inflammation and oxidative stress
28 days
Safety
28 days
Pharmacokinetics
28 days
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Radiant Research
Chicago, Illinois, 60610, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Related Publications (1)
Blum S, Asaf R, Guetta J, Miller-Lotan R, Asleh R, Kremer R, Levy NS, Berger FG, Aronson D, Fu X, Zhang R, Hazen SL, Levy AP. Haptoglobin genotype determines myocardial infarct size in diabetic mice. J Am Coll Cardiol. 2007 Jan 2;49(1):82-7. doi: 10.1016/j.jacc.2006.08.044. Epub 2006 Dec 13.
PMID: 17207726BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey G Geohas, MD
Radiant Research
- PRINCIPAL INVESTIGATOR
Michale Noss, MD
Radiant Reasearch
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 23, 2007
First Posted
June 26, 2007
Study Start
June 1, 2007
Study Completion
May 1, 2008
Last Updated
July 2, 2008
Record last verified: 2007-06